for 260th meeting... · web viewregistration board may also develop rationalized check list for...

Minutes for 260th Meeting Registration Board held on 28-29th June, 2016.

Item No. Detail of Item Page No(s)

Item No.I Confirmation for minutes of 259th Registration Board meeting 04

Item No.II Pharmaceutical Evaluation & Registration Division 05 - 375

Item No.III Biological Drugs Division 376 - 483

Item No.IV Quality Assurance & Laboratory Testing Division 484 – 490

Item No.V Additional cases 491 - 493

Minutes for 260th Meeting Registration Board 1

260th meeting of Registration Board was held on 28-29th June, 2016 in the Committee

Room, Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting was chaired by Mr.

Ghulam Rasool Dutani, Director Pharmaceutical Evaluation & Registration Division, DRAP. The meeting

started with recitation of the Holy Verses. The meeting was attended by the following:-

1. Lt General (R) Karamat Ahmed Karamat. Member

2. Brig (R). Dr. Muzammil Hasan Najmi, Associate Dean, Basic Sciences Division, Foundation University Medical College, Rawalpindi

Member

3. Mr.A.Q.Javed Iqbal Member

4. Sheikh Sarfraz AhmadAdditional Draftsman, M/o Law and Justice

Member

5. Mr.Ghulam Mujtaba, Assistant Director Representative of IPO

Member

6. Dr.Muhammad ArshadPresident, Pakistan Veterinary Medical Council

Member

7. Dr.Amanullah KhanDirector Drugs Testing Laboratory Government of Baluchistan, Quetta

Member

8. Dr.Muhammad Khalid KhanDirector Drugs Testing Laboratory Government of Khyber Pakhtunkhwa, Peshawar

Member

9. Mr.Abdus Salam ShahDirector Drugs Testing Laboratory Government of Sindh, Karachi

Member

10. Mr.Saleem Butt Director Drugs Testing Laboratory Government of Punjab, Rawalpindi

Member

11. Shaikh Ansar Ahmad,Director Biological Drugs Division, DRAP

Member

12. Dr.Noor Muhammad ShahDirector Medical Device Division, DRAP

Member

13. Dr.Abdur RasheedChairman, Quality ControlQA&LT Division, DRAP

Member

14. Dr. Obaidullah, Deputy Director General (Reg.I) Secretary


Dr.Muhammad Khalid Khan attended the meeting on 28.06.2016 while Dr.Muhammad

Arshad and Mr.Abdus Salam Shah participated on 29.06.2016 only.

Dr.Masud-ur-Rehman (DDG Biological), Zaheer-ud-Din M Babar (DDC R.I/R IV),

Muhammad Akhter Abbas (DDC/Incharge, PEC), Dr.Hafsa Karam Elahi (DDC,PEC),

Muhammad Amin (DDC R.V / DDC,PEC), Tehreem Sara (DDC RRR), Adnan Faisal Saim

(DDC,QC), Babar Khan (ADC R.II/RIII), Dr.Ghazanfar Ali Khan (ADC RRR), Salateen

Waseem Phillips (ADC,PEC), Muhammad Ansar (ADC,PEC) and Muneeb Cheema

(ADC,Biological) assisted relevant Directors and Secretary of the Board with agenda.

Shafiq Ahmad Abbasi, Ayub Siddique, Nadeem Alamgeer and Abuzar Faizi Rattu

attended the meeting as observer on behalf of PPMA, Pharma Beauru and PCDA respectively.

In addition to routine agenda, following was also discussed and decided:

Registration Board deliberated that only those drugs will be registered for import from India, which are as allowed / permissible as per Import Policy Order, 2016 (Ministry of Commerce).


Item No. I: Confirmation of minutes of 259th meeting Registration Board.

259th meeting of Registration Board was held on 30-31st May, 2016. Draft minutes were

circulated to all members (who attended the meeting) on 15.06.2016 through e-mail with the

request to forward their comments (if any) within 05 days. 02 members forwarded their

comments / observations, as follows:

Dr.Amanullah Khan, Director DTL, Quetta:

Item No.III, Case No.01:

It may be decided as per decision of Registration Board.

Dr.Noor Muhammad Shah, Director Medical Device, DRAP:

While discussing observation of Dr.Amanullah regarding registration of Injection Ropegra, the members were informed that the Board endorsed the statement of registration of the product in parawise comments submitted before the court and change in source was accordingly approved. Member including the undersigned stated that Board has its own wisdom and procedure for registration of drugs instead of endorsing of parawise comments. It was also submitted that as necessary requirements were fulfilled, registration should have been granted for the new source instead of change of source.

Keeping in view comments of Dr.Amanullah Khan, Director DTL, Quetta, respective

case is again placed as agenda item (Item No.II, Case No.01).

Decision: Registration Board deliberated that points observed by Director Medical Device, DRAP has already been discussed in previous meetings. Hence Registration Board confirmed minutes of 259th meeting Registration Board.


Item No. II: Pharmaceutical Evaluation & Registration Division.

Case No.01: New committee(s) for on-site inspection of stability data or any other assignments.

Registration Board in 258th meeting considered following proposal of Dr.Muhammad

Khalid Khan, Director DTL, Peshawar forwarded in response to draft minutes of 257th

Registration Board meeting. Dr.Amanullah Khan, Director DTL, Quetta has also endorsed these

observations.

As per decision of the Registration Board to verify stability data as per site and in this connection already one committee was constituted which is working. However as a member of Registration Board I do feel that only one committee is not sufficient to look after the entire Pharma of the country therefore to avoid unnecessary delay for onsite verification of the data the board may constitute new committee(s) in the public interest compromising of members of the Registration Board only. Registration Board may also develop rationalized check list for onsite verification of the data with clear, time Bound Terms of Reference.

Registration Board after deliberation deferred the case and advised Pharmaceutical Evaluation

Cell to bring complete details / data of stability datas submitted by the manufacturers in forthcoming

meeting. Accordingly, following data is submitted for consideration of Registration Board.

S.No Name of Drug & Composition No of applicants / manufacturers1. Capsule Dex-Lansoprazole 30mg, 60mg 022. Tablet Sofosbuvir 400mg 033. Tablets Cinacalcet 30 mg, 60 mg 014. Tablet Mirabegron 25mg, 50mg 015. Tablet Sitagliptin+Metformin XR 50/500,

50/1000, 100/100001

In 259th meeting, Registration Board decided as follows:

Registration Board deliberated the matter in detail and decided that already constituted panel (Brig (R) Muazmmil Najmi, Dr.Obaidullah and Dr.Saif-ur-Rehman Khattak) will continue to inspect pharmaceutical units for onsite investigation to confirm genuineness/ authenticity of stability data and associated documents, import of API, quality, specification, test analysis, facilities for Anti-retroviral drugs. For rest of formulations, following panels are constituted for aforementioned purposes.


Sind and Balochistan: Director DTL Karachi; Director DTL Quetta and area FID, DRAP.

Punjab: Director DTL Lahore; Director DTL Peshawar and area FID, DRAP.

Islamabad, AJK and KPK: Director DTL Rawalpindi; Director DTL Peshawar and area FID, DRAP.

Registration Board also approved above panels for confirmation genuineness/

authenticity of stability data and associated documents, import of API, quality, specification, test

analysis, facilities for various applications.

Decision: Registration Board deliberated the matter and decided that already constituted panel (Brig (R) Muazmmil Najmi, Dr.Obaidullah and Dr.Saif-ur-Rehman Khattak) will continue to inspect pharmaceutical units for onsite investigation to confirm genuineness/ authenticity of stability data and associated documents, import of API, quality, specification, test analysis, facilities for Anti-retroviral drugs. For rest of formulations, following panels are constituted for aforementioned purposes.

Sind and Balochistan: Director DTL Quetta (Chairman), Director DTL Karachi (Member); and area FID, DRAP (Member / Convener).

Punjab: Director DTL Peshawar (Chairman), Director DTL Lahore; and area FID, DRAP (Member/Convener).

Islamabad, AJK and KPK: Director DTL Peshawar (Chairman), Director DTLRawalpindi and area FID, DRAP (Member/Convener).

Case No.02: Price fixation under the Drug Pricing Policy-2015.

Drug Pricing Committee referred the under mentioned five cases of price fixation for

policy guidelines from the Policy Board of the Authority for price fixation of drugs whose plain

formulations or injections in vials/ampoules are available in the market at much lower prices and

the companies have applied for price fixation of sustained release formulations or injections in

prefilled syrings or modification in dosage administration / drug delivery device respectively.

These formulations are not new chemical entities and DPC could not find any guideline in the

Drug Pricing Policy -2015 to fix prices of these formulations at much higher prices. Therefore,

DPC decided to refer the following cases of price fixation to the Policy Board of the Authority

for policy guideline whose prcice fixation is not covered under the Drug Pricing Policy –2015.


S.No.

Drugs / Composition Reasons for referring to the Policy Board for policy guideline

1. Panadol Joint TabletsEach modified release tablet contains:-Paracetamol Ph Eur….665mg

M/s GSK, Karachi(M-243)

Plain tablets of Panadol 500mg of the same company are available @ Rs.180.00/200’s (Rs.0.90/- per tablet) and the company is demading Rs.200.00/20’s (Rs.10.00/- per tablet) for modified release of 665mg tablets.

Demanded price of 665mg modified release tablets @ Rs.10/- per tablet is much high in comparison to price of 500mg plain tablet of the same company available @ Rs.0.90/- per tablet.

It is not a new chemical entity. Reference price is neither available nor applicable. DPC decided to refer the matter to Policy Boar for policy guideline.

2. Sayana Press Injection PFS104mg/0.65ml (Medroxyprogesterone acetate)Pre-filled injection system contains Depo-medroxyprogesterone acetate (DMPA) 104mg/0.65ml

Imported by Pfizer Pakistan Limited, Karachi

Imported from Manufacturer: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium.

Main indications:Contraceptive, depot effective for at least 13 weeks.

The company is already marketing injection of Medroxyprogesterone acetate 150mg per 1ml in vial dosage form @ Rs.153.16/1ml x 1’s under the brand name “Depo-Provera”.

Now the company has applied for price fixation of same drug (Medroxyprogesterone acetate) for 104mg per 0.65ml under the brand name “Sayana Press Injection PFS” and demaned maximum retail price of Rs.1078/- per injection in Pre-filled syringe.

Demanded price of Sayana Press Injection @ Rs.1078/- per injection is much higher in comparison to already available brand “Depo-Provera” of the same company @ Rs.153.16 per injection (vial).



S.No.


3. Ritalin LA Capsules 20mg Each capsule contains:-Methyphenidate hydrochloride…..20mg(M-245)

Imported by M/s. Novartis Pharma (Pakistan) Ltd. Karachi/

Imported from M/s. Elan Holdings Inc, Georgiam, USA.

The company is already marketing Methyphenidate hydrochloride 10mg Tablets in plain tablet dosage form @ Rs.140.00 per pack of 10 tablets under the same brand name “Ritalin Tablets”.

Now the company has applied for price fixation of same drug (Methyphenidate hydrochloride) for 20mg per capsule under the brand name “Ritalin LA Capsules 20mg ” and demaned maximum retail price of Rs.2400.00/- for a pack of 30 capsules (Rs.80/- per capsule).

Demanded price of Ritalin LA Capsules 20mg @ Rs.2400.00/- for a pack of 30 capsules (Rs.80/- per capsule) is much higher in comparison to already available brand “Ritalin Tablets 10mg” of the same company @ Rs.140.00 per pack of 10 tablets (plain) (Rs.14/- per tablet).


4. Ritalin LA Capsules 30mg Each capsule contains:-Methyphenidate hydrochloride….320mg(M-245)




Now the company has applied for price fixation of same drug (Methyphenidate hydrochloride) for 20mg per capsule under the brand name “Ritalin LA Capsules 30mg ” and demaned maximum retail price of Rs.3200.00/- for a pack of 30 capsules (Rs.106.67/- per capsule).

Demanded price of Ritalin LA Capsules 30mg @ Rs.3200.00/- for a pack of 30 capsules (Rs.106.67/- per capsule) is much higher in comparison to already available brand “Ritalin Tablets 10mg” of the same company @ Rs.140.00 per pack of 10 tablets (plain) (Rs.14/- per tablet).



S.No.


5. Ritalin LA Capsules 40mg Each capsule contains:-Methyphenidate hydrochloride…..40mg(M-245)




Now the company has applied for price fixation of same drug (Methyphenidate hydrochloride) for 20mg per capsule under the brand name “Ritalin LA Capsules 40mg ” and demaned maximum retail price of Rs.3900.00/- for a pack of 30 capsules (Rs.130/- per capsule).

Demanded price of Ritalin LA Capsules 40mg @ Rs.3900.00/- for a pack of 30 capsules (Rs.130/- per capsule) is much high in comparison to already available brand “Ritalin Tablets 10mg” of the same company @ Rs.140.00 per pack of 10 tablets (plain) (Rs.14/- per tablet).


Policy Board of the Authority in its 14th meeting held on 10th & 11th September, 2015 had

referred the matter to the Drug Registration Board to decide a specialized dosage form whether it

is a new drug or not and its price is to be granted. Accordingly as a new product or a same

product but different strength / different pack size as both are separately mentioned in the Drug

Pricing Policy-2015.

Decision: Mr.Abdul Ghaffar, DDC (Pricing) apprised Registration Board about the case. The Board deferred the case for decision of DRAP’s Policy Board in instant case for further deliberation.


RRR Division

Case No.03: Renewal of registered drug and Post-registration variation approval.

In 243rd Meeting of the Registration Board a following decision was made post-

registration variation was made and the extract is as under:

“Registration Board deliberated that transfer from one importer to another (with no change in manufacturing site), change of brand name and change of name of manufacturer will be considered as post-registration variation. Moreover, this approval will not be considered as renewal of the product and firm will apply for renewal of product as per procedure and will be processed as per import policy for finished drugs.”

Although decision was made as above but notification to this effect for not considering

post-registration variations towards renewal products was not issued and the firms are still

considering/applying renewal of registration from their date of post-registration variations.

Case was deliberated in 259th Registration Board meeting and decided to bring the issue

as agenda in the forthcoming meeting for discussion.

Decision: Registration Board deliberated on the matter at length and decided post-registration variations shall not be considered towards renewal of products w.e.f 01-10-2016. However, it was observed that renewal applications already submitted or to be submitted till 30.09.2016 shall be considered from post registration varioation, if appled by the firm.

Case No.04: Renewal of Registered drugs.

Number of applications submitted for renewal of drugs which are incomplete or have

shortcoming especially with reference to the submitted prescribed renewal fees. The following

applications for renewal of drugs are submitted on Form 5-B after the expiry of validity of the

certificate of registration but within sixty days after validity of certificate of registration. The

applications for renewal are incomplete with reference to renewal application fee or having some other

deficiency.

Rule 27 Drug (Licensing, Registering & Advertising) Rules, 1976 (Duration of certificate of registration). A certificate of registration under this chapter, [shall unless earlier suspended or cancelled, be in force for a period of five years from the date of [Registration of the drug] and may thereafter be renewed for period not exceeding five years and a certificate to this effect shall be issued within one month] at a time.


Provided that an application for the renewal of registration shall not be entertained unless it has been made within sixty days after the expiry of the registration and when an application has been made aforesaid the registration shall subject to the orders passed on the application for the renewal continue in force for the next period of five years and a certificate to this effect shall be issued within one month]. Provided further that in case of an imported drug, the renewal may be granted and a renewal

certificate shall be issued, if in the opinion of the Registration Board it is necessary to do so in the

public interest.

Following cases are placed below for the consideration of Registration Board.

a. M/s Prix Pharma Lahore.

S.No

Reg/No Products/Name Initial Date of Registration

Application receiving dateand fee submitted date/ and due date

1 014568 Farbenda Oral Suspension Each ml containsAlbendazole…. 100 mg

22-2-1994 Due date (21-2-2014)17-3-2014Fee of Rs. 40,000/- deposited on 17-03-2014

Decision: Firm submitted renewal application within 60 days of expiry period of registration time i.e; 17-03-2014 with fee of Rs. 40000/-, therefore Registration Board decided to grant renewal of above product till 21-02-2019 subject to adherence to the Import Policy for Finished Drugs.

b. M/s Navegal Laboratories Rawalpinid.

S.No

Reg/No Products/Name Date of transfer of

Reg.


1 015732 Naveten 1 mg tablet Each tablet containsKetotifen Fumerate.. 1 mg


2 015731 Piram 20 mg capsuleEach capsule containsPiroxicam…..20 mg

dodo

3 018979 Zantidon 150 mg tabletsEach tablet containsRanitidine HCl… 150 mg

dodo


Decision: Firm submitted renewal application within 60 days of expiry period of registration time i.e. 19-02-2013 with full fee, therefore Registration Board decided to grant renewal of above products at serial No. 1 to 3 till 20-01-2018.

c. M/s Nabiqasim Industries (Pvt) Ltd Karachi.

S.No

Reg/No Products/Name Initial Date of

Registration


1 053139 Deplat-AP TabletEach tablet containsClopidogrel(as bisulphate)…. 75 mgAspirin BP….. 75 mg(Manufacturer’s Specification)


2 053135 Lungair 4 mg tabletEach chewable tablet containsMontelukast Acid (as sodium)………. 4 mg(Manufacturer’s Specification)

dodo

3 053142 Valset 250 mg tabletEach tablet containsValproic Acid (as sodium)………. 250 mg(Manufacturer’s Specification)

do do

4 053133 Ordiab 5/500 tabletEach tablet containsGlipizide……. 5.00 mgMetformin Hydrochloride… 500 mg(Manufacturer’s Specification)

do do

5 053138 Clarithro 125mg/5ml Oral DropsEach 5ml containsClarithromycin …….. 125 mg(Manufacturer’s Specification)

do do

6 053140 Lumether tabletEach tablet containsArtemether ……… 20.00 mgLumefantrine…… 120.00 mg(Manufacturer’s Specification)

do do

7 053136 Lungair 4 mg SachetEach chewable tablet containsMontelukast Acid (as sodium)………. 4 mg(Manufacturer’s Specification)

do do


Decision: Firm submitted renewal application within 60 days of expiry period of registration time i.e; 10-12-2013 with full fee, therefore Registration Board decided to grant renewal of above products at serial No. 1 to 7 till 30-11-2018.

d. M/s Mediate Pharmaceuticals (Pvt) Ltd Karachi.

S.No

Reg/No Products/Name Initial Date of Reg.


1 006919 Mefenemic tablet Each tablet containsMefenamic Acid……. 250 mg

9-3-2004 Due date (8-3-2014)11-3-2014Fee of Rs. 10,000/- deposited on 11-3-2014. Remaining fee of Rs/ 10,000 deposited on 18-5-2016

2 012123 Tr.Iodine SolutionEach containsIodine……… 5 gmPotaqssium Iodide……. 10 gm

do do

3 012449 Benephal CapsuleEach Capsule containsCephalexin……….. 250 mg

do do

4 012451 Lakenine CapsuleEach capsule containsAmpicillin Trihydrate eq.to Ampicillin Base…..250 mg

do Do

5 006920 Seladrine tabletEach tablet containsChloroquine Phosphate eq.toChloroquine base……. 80 mg

do Do

6 004327 Seladrine tabletEach tablet containsChloroquine Phosphate250 mg

do Do

7 011342 Frusemide tabletEach tablet containsFrusemide……….. 40 mg

do Do

8 010526 Trupentine LinimentContainsSoft Soap……….. 75 gmTurpentine Oil…… 650 mlPurified water…….. 225 ml(Fresh boiled& cooledCamphor……….. 50 gm

do Do


9 010287 Polter past OintmentEach 400 gm containsHeavy Kaolin……..52.7 gmBoric Acid………….04.5 gmMethylsalicylate…….. 00. 2mlThymol…………….. 50.0 mgPepermint Oil…… 0.05 mlGlycerol………….. 42.5 gm

do Do

10 004488 Aspera-Co tabletEach tablet containsAspirin…………… 300 mgParacetamol……….. 200 mgCaffeine…………. 30 mg

do Do

11 009043 Feverol SuspensionEach 5ml containsParacetamol………… 120 mg

do Do

12 010289 Decmasil tablet Each tablet containsMagnesium Trisilicate.. 500 mg

do Do

13 011180 Duocarte SolutionContainsSalicylic Acid…….. 16.7%Lactic Acid………. 16.7%

do Do

14 012125 Decsazone tabletEach tablet containsDexamethasone……… 0.5 mg

do Do

15 012124 Aminophylline tabletEach tablet containsAminophylline………. 100 mg

do Do

16 006917 Dep-Roll tabletEach tablet containsAspirin…………. 300 mg

do Do

17 010286 Inchthazmol GlycerinEach containsInchthazmol Glycerin….10%/w/w

do Do

18 012448 Benaphal CapsuleEach capsule containsCephalexin………… 500 mg

do Do

19 009352 Cetadrine tabletEach tablet containsEphedrine………….. 30 mg

do Do

20 009042 Anatrate SyrupEach 5ml containsSodium Citrate……. 37.625 Kgs Citric Acid………. 14.200 Kgs

do Do


21 004489 Predamenium tablet 4 mgEach tablet containsChlorpheniramine Maleate…. 4mg

do Do

22 009044 Freshmasil SyrupEach 5ml containsAmmonium Chloride….. 100 mgSodium Citrate…… 60 mgChlorpheniramine Maleate…… 2mgEphedrine HCL….. 7 mgMenthol…………. 1 mg

do Do

23 010525 Mercurochrone SolutionContainsMercurochrone Solution….1%/w/wClean Skin LotionContainsCalamine………….. 15%

do Do

24 004601 Ascorbic Acid tabletEach tablet containsAscorbic Acid……… 50 mg

do Do

25 007032 Cake-Sea 500 tabletEach tablet containsAscorbic Acid……. 500 mg

do Do

26 006918 Paracetamol tabletEach tablet containsParacetamol ………. 500 mg

do Do

27 010524 Gentian Violate PaintContainsCrystal Violet in water…. 0.5%/w/w

do Do

28 007033 Mad folic tabletEach tablet containsFolic Acid………. 5 mg

do Do

29 009353 Kotria tabletEach tablet containsTrimethoprim………. 80 mgSulphamethoxazole……. 400 mg

do Do

30 004328 Paracambind tabletEach tablet containsParacetmol ………..300 mgAspirin……….. 200 mg

do Do

31 010577 Clean Skin SolutionContainsCalamine………..15%

do Do


32 012450 Lakcine CapsuleEach capsule containsAmpicillin Thydrate eq.to Ampicillin Base ……500 mg

do Do

33 006921 Sodamint tabletEach tablet containsSodium Bi Carbonate… 300 mg

do Do

34 004602 Kaleup tabletEach tablet containsCalcium Lactate…… 300 mg

do Do

35 004603 Sulphadiazine tabletEach tablet containsSulphadiazine……. 500 mg

do do

Decision: Firm submitted renewal application within 60 days of expiry period of registration time i.e; 11-03-2014 with full fee, therefore Registration Board decided to grant renewal of above products at serial No. 1-35 till 08-03-2019.

e. M/s Shaheen Pharmaceuticals Swat.

S.No

Reg/No Products/Name Initial Date of Registration


1 068418 Butone ElixirEach 5ml containsPhenobarbitone…….20 mg(shaheen Specification)

2-12-2010 Due date (1-12-2015)3-12-2015 Fee of Rs/10,000 deposited on3-12-2015 remaining fee of Rs 10,000/- deposited on 15-2-2016

Decision: Firm submitted renewal application within 60 days of expiry period of registration time i.e. 03-12-2015 with full fee, therefore Registration Board decided to grant renewal of above product till 01-12-2020.


Registration-I

Case No.05: Request for change of manufacturer of Kefei ® Injection (Reg.No.059054) by M/S. RG Pharmaceutical (Pvt.) Ltd, Karachi.

M/s. RG Pharmaceutical (Pvt) Ltd., Karachi had applied for change of

manufacturer/manufacturing site for their following already registered imported human product

from M/s. Guangzhou Lifetech Phrmaceutical Co. Ltd., China to M/s. Reyoung Pharmaceutical

Co., Ltd No. 06 Erlangshan Road, Yiyuan County, Shandong Province, P.R China:-

S. No. Reg. No. Name of Products.1. 059054 KeFei ® Injection

Each vial contains:-Levocarnitine for injection 1.0gm.

The firm have deposited required fee Rs.100,000/- and submitted following supporting documents:-i) Application on Form 5A.ii) Copies of initial registration letters & renewal status.iii) Original & legalized CoPP & GMP from China regarding new manufacturing facility.iv) Site master plan of the manufacturer.

In 259th meeting The Registration Board observed that following points needs to be

clarified before taking decision:-

i. Brand name owner.ii. Sole agency agreement from the new proposed manufacturer.iii. NOC from previous manufacturer for the proposed change.iv. Approval status by reference regulatory authorities.

The firm has submitted sole agency agreement from the new proposed manufacturer and

NOC from previous manufacturer mentioning that change of manufacturer of Kefei ® Injection

as requested above.

The availability of the drug as lypolized powder could not be confirmed in reference

countries like USA, EMA etc. Moreover, the Board observed that there is need to establish the

product license holder as in the CoPP given by the firm product license holder is mentioned for

generic name and brand name Kefei is not mentioned.

Decision: Registration Board advised to provide evidence of approval of the drug (lyophilized form) by regulatory authorities of reference countries and also to


clarify the product license holder, who is authorized to make such request alongwith supporting document.

Case No.06 Application for registration of drug of M/S. ICI, Karachi - remanded back by Drug Appellate Board in its 144th Sitting.

The Appellate Board in its 144th sitting held on 22-12-2015 has, interalia, decided

to remand back the case filed by M/s. ICI, Karachi regarding rejection of transfer of registration

applications of following products:-

S. No. Reg. No. Brand Name1 063792 Alba 10 Plus Suspension2 075666 Alba 10 suspension3 026563 Alba-25 suspension4 063787 Albasan Plus 2.5 Suspension5 069607 Alpro Suspension6 059134 Bendol 2.5 Suspension7 059153 Bendol 10 Suspension8 059129 Clobendol 2.5 Suspension9 063798 Cypercid Liquid10 035082 Creezan suspension11 059165 Cypermet Liquid12 059161 Darsul Liquid13 063559 Devotyl Liquid14 063549 Enrolac 10 Liquid15 075663 Enrocam Liquid16 059113 Levanil Drench17 075671 Motil Liquid18 059144 Noworm Plus Suspension19 059130 Oxanil Drench20 063800 Oxfenox Plus Suspension21 058800 Oxyfen S.C Drench22 063790 Oxypro Drench23 059124 Paranil Plus Suspension24 059143 Paranil Gold Suspension25 063556 Pulmopro Liquid26 059109 Disulf Liquid27 075656 Resporal Liquid28 075667 Solvita-S Solution 29 002821-E Sist-Mix Drench30 075665 Tryton suspension31 075669 Tolzur Plus Liquid32 075670 TY-Dox Plus Liquid33 059107 Tenex Plus 8.75 Drench


34 057131 Toltrox Oral Solution35 063791 Triclev 8.75 Drench36 058780 Trisole S.C Drench37 063563 Vorcid Suspension38 059141 Wantox Drench39 059110 Wantox Plus Drench40 059103 Wantonil Plus Suspension41 059155 Zurox Oral Solution42 059150 Alincospectin Water Soluble Powder43 075662 Almoxin-C Water Soluble Powder44 075677 Avicox Water Soluble Powder45 063555 Clarinal Powder46 059154 Colicid Water Soluble Powder47 063548 Colint Water Soluble Powder48 059181 Comox Water Soluble Powder49 059131 Cyclo-Mix 20 Premix 50 075668 Coxikil Water Soluble Powder51 063796 Diurex Powder52 059115 Doxityl WSP53 059166 Doxi-Mix 50 Powder54 063799 Etholon Powder55 063788 Lincamox-S Water Soluble Powder56 059159 Linco-Mix II Premix57 075673 Macrodox Water Soluble Powder58 059146 Neo-Stin Water Soluble Powder59 075659 NCO-60 Water Soluble Powder60 075660 Rapid-TD Water Soluble Powder61 063797 Somcox Powder62 057126 Sulfa-Vito Water Soluble Powder63 057130 Sulzin Powder64 075658 Super Leva Water Soluble Powder65 075672 Super Flush Water Soluble Powder66 059119 Trifon Powder67 075657 Triclofon Powder68 057129 Tydox Water Soluble Powder69 059160 TY-Mix 10 Premix70 049532 Ventilax Water Soluble Powder71 059157 Vitavit-Adek Feed Premix72 063553 Voladol Premix73 059117 ZPS-100 Powder74 052371 Almoxin 15% L.A Injection75 063564 Amivit Injection76 063551 Amcolox L.A Injection77 059135 Amoxicure L.A Injection78 063550 Amoxilist LA Injection


79 002820-E Bi-Sel E Injection80 002819-E Bi-Strep Injection81 057146 Biosign Injection82 063552 Cal.D Lyte Injection83 059175 Cefpro Injection84 063557 Ceftron Injection85 059174 Coligent Injection86 071050 Control-CRD Injection87 063786 Dayfos Injection88 075654 Dimox Injection89 059156 Diaminac Granules for Injection90 059132 Diclonac Plus Inj.91 059138 Dimenol Injection92 063795 Dipyrene Plus Injection93 059182 Dectron Injection94 059147 Distilled Water for Injection95 059106 Disulf Injection96 057142 Dorvet Injection.97 069606 Enrolac-10 Injection98 059178 Enro-Pro10 Injection99 059125 Flunix Injection.100 059126 Fostel Injection101 059136 Genton Injection 10%102 075664 Genton 5% Injection103 063558 Gentamix Injection104 059151 Gencotyl Injection105 059148 Gentrax Injection106 059133 HIT-CRD Injection107 059152 Ivoron Injection108 059127 Ivoron Super Injection109 063554 Melonac Injection110 075652 Melonac Plus Injection111 063794 Megaflux Injection.112 059142 Mectin Plus Injection113 057147 Metagen Injection114 063547 Moxin Injection115 059114 Onyx 50 Injection116 075653 Oxytron LA Injection117 059137 Onyx 100 Injection118 059128 Onyx LA Injection119 059149 Orasone Injection120 075661 Oxytron 100 Injection121 059145 OTC Forte LA Injection122 057095 Pred Gold Injection123 063561 Progent Injection


124 059162 Provet 40 Lac Dry Injection125 075676 Pyraminol Injection126 075674 Solodex Injection127 075675 Supernova Infusion128 059120 Spectral Injection129 059158 Strepciben 5gm powder for Inj.130 059176 Strepcin Injection131 059180 Top-Vet Injection132 059123 Triben Injection133 057135 Triface Injection134 057137 Tylo 2DHS Powder for Injection135 002822-Ex Tri-Vit+ Injection136 059108 Tylogent Injection137 063789 Tylox-P Injection138 059163 Tycolimet Injection139 059173 Tylo-Pro 10 Injection140 059177 Tylo-Pro 20 Injection141 063793 Tryton Injection142 075655 Tylox-20 Injection143 059179 VAD3 Injection 144 059164 V-Sel Injection145 057128 Variax Injection146 063560 Vigorin Injection147 044980 Albenda 250 Bolus148 059104 Benvet Plus 250 Bolus149 069605 Bendol 250 Bolus150 059111 Bendol 500 Bolus151 059139 Bengral Granules152 059105 Benvet 600 Bolus153 063562 Clovet Bolus154 044978 Dart 350Bolus155 059112 Deworm Bolus156 059116 Fendamax Plus Bolus157 059118 Nitron Bolus178 002378-EX Oxyclozanide Super 750mg Bolus159 059140 Paranil Bolus160 044979 Zanisol Bolus161 059122 Incramilk Granulated Powder

The Brief of the case presented in Registration Board meeting No. 245th held on 29-30th September, 2014, is as under:-

M/s. ICI Pakistan Limited, Karachi had applied jointly with M/s. Breeze Pharma (Pvt)

Limited, Islamabad to the Central Licensing Board for acquisition of their license


premises situated at 125, 126, 127-A, Industrial Triangle, Kahuta Road, Islamabad, on

the basis of a registered Lease agreement, they have applied for transfer of

registrations of above mentioned 161 products from M/s. Breeze Pharma (Pvt)

Limited, Islamabad to their name and deposited an amount of Rs.3,320,000/-, as the

required fee in the DRAP account.

M/s. ICI Pakistan Limited, Karachi later informed that as the Central Licensing Board

vide its orders communicated under letter dated 4th February, 2014, decided that

instead of transfer of DML No.000659 (Formulation) M/s. ICI Pakistan Limited shall

apply for grant of fresh DML after surrendering of Licence and Inspection Book issued

to M/s. Breeze Pharma (Pvt) Limited, Islamabad, so their application for transfer of

registration has been rendered redundant and stands effectively aborted, as neither of

the parties agrees to such terms and the same would cause a drastic shortage of the

concerned drugs in the market against the spirit and requirements of the law and

relevant rules. They have therefore requested that the amount of Rs.3,320,000/-

deposited as above be refunded and returned to them to foreclose the issue.

The applications for the grant of registrations are submitted under rule 26 of the Drugs

(Licensing, Registering & Advertising) Rules, 1976. The fee is deposited under sub-

rule 3 of the rule 26. The Rule 26 (6) stats “Any Fee deposited under sub-rule (3) shall

not be refunded”. Moreover, the applications were submitted for transfer of

registration which can not be approved as the central licensing Board has not acceded

to their request.

Registration Board in its 245th meeting held on 29-30th September, 2014, after detailed

deliberations and keeping in view decision of the Central Licensing Board rejected the

applications of M/s. ICI Pakistan Limited, Karachi for transfer of registrations of 161

products from M/s. Breeze Pharma (Pvt) Limited, Islamabad to their name.

The proceedings, observation and decision of the Appellate Board is as under:-

The appellant submitted the following arguments, as already stated in their appeal that:i. They never applied for transfer of registration. They applied for grant of

registration.ii. Against their request for refund of fee, they received letter that the Registration

Board has rejected their applications for transfer of registration of 161 products.


iii. They were trying to acquire a running business.iv. Sub-Rule (3) of rule 26 of the Drugs (Licensing, Registration & Advertising)

Rules, 1976, which stipulates that the fee deposited in no case be refunded, stood omitted by SRO 662(I)/2005 dated 25-06-2005.

v. Why their application submitted in 2013 were considered while applications for registration of January, 2011, were pending.

b. The respondents stated that the firm applied for the transfer registrations to the 161 products, which were registered in the name of Breeze Pharma (Pvt.) Ltd; to their name. Refund is not allowed under rule 26 (6) of the Drugs (Licensing, Registration and Advertising) Rules, 1976.c. The Board observed that:

i. No explicit decision was made by the Registration Board on the specific of the Appellant for refund of the fee.

ii. The Appellant prematurely applied for transfer of grant of registration, as the case may be, before the final decision on their request by the Central Licensing Board.

iii. Appeal was applied based on a decision communicated vide letter No.F.3-4/2014-Reg-I(M-245) dated 06-11-2014, wherein their request for transfer of registration of 161 products from M/s. Breeze Pharma (Pvt.) Ltd; Islamabad to their name was rejected. But the Appellant was contesting their request of refund instead of rejection of their request for transfer.

Decision of Appellate Board:-In light of the above, the Board decided to remand back the case to Registration Board

for precise and specific decision on the request of the Appellant for refund of their fee. The Registration Board in its 259th meeting deferred the case for having clear rule positions particularly with reference to issue of refund of registration fee.

The applications for the grant of registrations are submitted under Rule 26 of the Drugs (Licensing, Registering & Advertising) Rules, 1976. Earlier, the fee was deposited under Sub-rule 3 of the Rule 26 which specify registration fees to be submitted. The Sub-rule 3, however, was omitted vide SRO 662(I)/2005 dated 25-06-2005, while the Sub-rule 6 of Rule 26, which states that “Any Fee deposited under sub-rule (3) shall not be refunded”, is intact.

Decision: Registration Board observed that sub-rule 3 of Rule 26 of Drugs (Licensing, Registering & Advertising) Rule 1976 can not be read in isolation. Sub-rule 3 is an integral part of Rule 26 and also referred in sub-rule 3(b). When sub-rule 3 was omitted, a consequential amendment was to be made in sub-rule 6 where the reference of sub-rule 3 should have been substituted with the reference to sub-rule 3(b). This consequentianal amendment was not carried out which is very nominal consequential omission and does not render the contents of sub-rule(6) in-effective. Therefore, the fee is not to be refunded as the applications have already been rejected by Registration Board.


Case No.07: Show cause notices issued to the firms having registration of products containing Ciprofloxacin for veterinary use.

The Registration Board in its 249th meeting had decided to issue show cause

notices for cancellation of all the drug formulation having Ciprofloxacin for veterinary use for

the reason of development of resistance in human. Accordingly show cause notices were issued

to the firms having registrations of aforementioned drug formulations. A number of firms have

responded with their point of view including request for personal hearings.

The case was placed before the Registration Board in its 257th meeting and the Board

directed to place comments of all firms / stake holders before the Board in its next meeting.

Accordingly the responses of the firms are being placed before the Board. The salient points, of

the responses received are summarized as under:-

i) The Board may considered taking legal measures to avert unnecessary use and ensuring compliance of withdrawal period after treatment.

ii) Opinion of technical expert/veterinary expert committee may be taken before making any decision in this regard.

iii) Transfer of drug resistance from animal bacteria to human bacteria is not reported strongly.

iv) Putting ban on over the counter sale of such antibiotic. v) Under Section 7 (11) of Drugs Act, 1976, detail of the, information or enquiry

conducted or comprehensive data/record/documents, on the basis of which the decision was taken, may be communicated for response.

vi) A few firms also agreed to withdraw and requested for grant of registration of other products.

vii) Most of the firm requested for opportunity for personal hearing.

Registration Board deferred the case in its 258th meeting due to paucity of time. The case

was again taken by in its 259th meeting held on 30th -31st May, 2016 and the Board decided to call

the firm's having registration of such products for personal hearing.

Notices for personal hearing to the firms have been issued.

Decision: Representatives of M/s. Tarobina Corporation, SB Pharma, Bio Labs, Vet-con Pharmaceuticals, Attabak Pharmaceuticals, Cheris Pharma, and Grand Pharma appeared before the Board. The firm representatives were of the view that there is need together credible scientific data for establishing the claim of development of resistance in human due to veterinary use of ciprofloxacin. However, firm’s representatives agreed to proposal of de-reg-


istration as the drug is not used in veterinary practices in reference coun-tries. They further requested that in order to save from financial losses may be given sufficient time to liquidate the existing stocks and substitute regis-tration of another product may be given to them on priority. Keepining in view above discussion, the Board in princiale agreed to de-register all the products having Ciprofloxacin for veterinary use. However modalities for implementation to this effect will be further deliberated in forthcoming meet-ing.

Case No.08: Request for Registration of Drug(s) under Drug Act, 1976 by M/s. Unicare Enterprises, Faisalabad.

The Registration Board in its 237th meeting held on 26-02-2013 constituted a sub-

committee for evaluation of applications of veterinary product for ensuring completion of codal

formalities. The Board further authorized Chairman, Registration Board for taking decision on

recommendations of the committee.

The sub-committee in its meeting held on 25-04-2013 approved the following products of M/s.

Unicare Enterprises, Faisalabad, manufactured by M/s. Laboratorios Karizoo S.A. Caldes De Montbui,

Barcelona, Spain, subject to inspection of manufacturer abroad, verification of storage facilities as per

policy:-

S. No. Name of Drug(s) Demanded Pack sizes

Demanded Shelf life

1. Lincosol 40% Oral PowderEach gm contains:-Lincomycin (as lincomycin hydrochloride)…………400mg(Antimicrobial).

Decontrolled100gm500gm1 Kg

2.5 Kg5 Kg10 Kg

03 years

2. Kariflox 10% Oral Solution Each ml contains:-Enrofloxacin…100mg/ml solution(Antimicrobial).

Decontrolled1 Liter5 Liter10 Liter25 Liter

03 years

3. Amoxicilina 500 KarizooEach gm contains:-Amoxicillin Trihydrate….500mg(Antimicrobial).

Decontrolled200gm400gm1 Kg

2.5 Kg5 Kg10 Kg

02 years


The firm has deposited fee of Rs. 1,00,000/- per product. The storage facility of the

importer has already been verified by the Area FID and as per new Import Policy of Medicine,

the product approved by regulatory authorities of Western European counties including Spain

may be exempted from inspection of manufacturing facilities.

While processing M/s. Unicare Enterprises, Faisalabad request for issuance of registration letter

of above drugs, it was noted that the pack sizes mentioned on CoPP are as under:-

Lincosol 40% Oral Powder 100gm, 1KgKariflox 10% Oral Solution No pack size mentionedAmoxicilina 500 Karizoo 200gm, 400gm & 1Kg

While the firm has demanded no of pack sizes which are not included in the CoPP of

exporting country.

The case was considered in 259th meeting of the Registration Board and the Board decided as under:-

a. Approved the pack size of the products which are already mentioned in their CoPP.b. For pack sizes not mentioned in the CoPP, the Board deferred the case for further

deliberation.

With reference to Kariflox 10% Oral Solution the firm has now submitted a copy of

Summary of Products Characteristics (SPC) which it claims to be part of CoPP. As per clause 6

of SPC the packs sizes of 250ml, 1 Liter 5 Liter are mentioned. The firm has requested to grant

them the same packing.

Decision: Registration Board decided as under:-

i. For the product Kariflox 10% Oral Solution, the pack size mentioned in SMPC i.e. 250ml, 1 liter and 5 liters is approved.

ii. It was also decided that in future the pack size approved by the reference regulatory authority, or those approved by the regulatory authority of exporting country as mentioned in CoPP, SMPC shall be considered for approval.


Case No.09: Request for Registration of Surgical Sutures by M/S. Zenith International, Karachi.

Registration Board in its 243rd meeting deferred following products for expert opinion.

1. M/s. Zenith International, Karachi. /

Manufactured by M/s. Sutures India (Pvt) Ltd. Bangalore, India.

“Trugut” Chromic Catgut (Absorbable Surgical Suture U.S.P) (With or Without Needle) (All sizes)

(Surgical Suture).

As per PRC 05 years

Rs.15000 +

Rs.85000 =

Rs.100000/-

The product, however, was not sent for expert opinion as the firm did not provide the EC

certificate. The firm subsequently claimed that EC Authority do not issue CE certificate to any

manufacturer for Chromic Catgut since several years. They further claimed that their principal is

exporting this product to USA. The Board in 254th meeting, while considering the case, advised

that the firm should provide an appropriate certificate from the concerned regulatory authority as

evidence of it’s free sale.

The firm later provided a legalized and attested free sale certificate issued by Indian

authorities. The case was considered in the 259th meeting the Registration Board and the Board

deferred the case for confirmation of importability from India as per Import Policy Order, 2106.

The product is not included in the list of items not importable from India.

Decision: Registration Board decided to defer the case for ascertaining the approval status by reference regulatory authorities. Moreover, the sizes also need to be specified and clarification is required with regards to differentiation of the sutures with needle and without needle.

Case No.10: Deferred drugs for expert opinion regarding for the use of formulation of phenylbutazone.

Registration Board in its 257th meeting held on 24-25th March, 2016 deferred following

case for taking expert opinion of veterinary experts regarding use of the formulation in veterinary

practice.


S. Name of Manufacturer

Name of Drug (s) Composition &

Therapeutic Group.

Demanded

Price & Pack Size.

Shelf Life

1. M/s Prix Pharmaceutica (Pvt) Ltd. Plot # 5 Pharmacity, 30-Km Multan Road, Lahore.

Pri-Phen 20 Injection

Each ml injection contains:- Phenylbutazone.…….200mg

(NSAID)

50ml 02 years

The opinion of the experts is as under:-

Prof. Dr. M. Shoaib Akhtar, Professor of Pharmacology, Faculty of Pharmacy, University of Sargodha.

Prof. Dr. Muhammad Ashraf (T.I),

Professor of Emeritus,

Department of Pharmacology and Toxicology,

University of Veterinary Animal Sciences, Lahore.

Brig (R). Dr. Muzammil Hasan Najmi, Associate Dean, Basic Sciences Division, Foundation University Medical College, Rawalpindi.

According to the published literature Phenylbutazone has been one of the earliest NSAIDS approved for use in horses and dogs for the relief of the relief of inflammatory conditions associated with the musculoskeletal system. It is available in the form of tablet, paste gel and parenteral (injectable) formulations. However, there is no Phenylbutazone product for approved use in food animals in USA. But it can be used as extra label drug in dairy cattle as well in less than 20 months old animals.Therefore, keeping in view the literature attached, I feel like recommending the use of this

i) Phenylbutazone is a nonsteroidal anti-inflammatory drug with same indications as other NSAIDs.

ii) In veterinary practice it is quite effective and is commonly used in horses.

iii) FDA also has approved its preparations for use in Horses and Dogs.

iv) The drug is not for use in cattle/buffalo/sheep/ goat as zero tolerance policy in meat/milk/eggs due to chances/ problem of lethal idiosyncrative agranulocytosis by

Awaited.


drug formulation (Pri-Phen 20 Injection) use in veterinary practice, especially in equines, cats and dogs. However, when used in food producing species, the withdrawal time periods must be taken care due to the toxicity problems associated with the drug residues.

Phenylbutazone reported in human.

v) Phenylbutazone is banned for use in any animal intended for human consumption because it causes serious and lethal idiosyncratic adverse effects in human.

vi) Effect of Phenylbutazone is bone-marrow toxicity, leading to agranulocytosis.

vii) Product "Pri-Phen 20 Injection" may be approved for use in equines and dogs only.

The Registration Board deferred the case in its 259th meeting for confirmation of approval

status by reference regulatory authorities.

As per information available on the website Phenylbutazone is not permitted for use in

food producing animals by USFDA and EMA.

Decision: Registration Board, in view of the expert opinion and status of use of phenylbutazone in reference regulatories authorities decided as under:-

i. Rejected the application of Pri-Phen 20 Injection as drug is not recommended for use in food producing animals.

ii. Issue show cause notices to all registered veterinary drug formulation containing phenylbutazone.

Case No.11: Import of Phenylbutazone by M/S. International Pharma Labs. Lahore for manufacturing of already registered drugs.

M/s. International Pharma Labs. Lahore has informed that their imported consignment of

Phenylbutazone raw material for manufacturer of their registered drug Phenylbutazone Injection

(Registration No.041231) has been withheld by the Assistant Drugs Controller, Lahore office


with the advise to get clarification from DRAP on whether use of Phenylbutazone in veterinary

product has been discontinued or not. The firm has requested for necessary clarification.

As per record of this office no formal instruction has been issued for discontinuation of

Phenylbutazone for veterinary use. However, the product is under review by the Registration

Board alongwith number of other veterinary drugs but, so far, no decision has been taken.

Since 218th meeting held 2009, the Registration Board used to refer the cases of

combinations, containing Phenylbutazone, to the Veterinary Expert Committee. As per available

record of VEC meetings (74th to 76th meeting) no recommendations were finalized.

The Registration Board in its 259th meeting deferred the case till decision of preceding case.

Decision:- Registration Board decided to defer the case till finalization of under consideration issue of the registration of phenylbutazone containing products.

Case No.12: Lack of interest for getting registration of approved oncology products by M/S. Novartis Pharma, Karachi.

The Registration Board in its 236th meeting held on 20th November, 2012

approved the registration of following imported drugs in the name of M/s. Novartis Pharma

(Pakista) Limited, Karachi Manufactured by firm as mentioned in column II subject to inspection

of manufacturer abroad, verification of storage facilities and price fixation / calculation etc, as

per policy:-

S. No.Name of applicant & Manufacturer

Name of Drug(s) Demanded Price

Shelf life

Remarks

1. M/s. Novartis Pharma (Pakistan) Limited, Karachi. /M/s. Ebewe Pharma Ges.m.b.H. Nfg. KG MondseestraBe Unterach, Austria.

Oxaliplatin “Ebewe” 150mg InjectionEach vial contains:-Oxaliplatin…150mg(Anticancer).

Rs.30000/ Per vial

03 years

Rs.28,500/ Per vial

7th DPC (DRAP)Complete address

of the manufacturer has been mentioned

on registration letter as per CoPP.


2. M/s. Novartis Pharma (Pakistan) Limited, Karachi./M/s. Ebewe Pharma Ges.m.b.H. Nfg KG Unterach, Austria.

Neoflubin 50mg/2ml injectionEach vial contains:-Fludarabine Phosphate……50mg/2ml(Anticancer).

Rs.13262.70/1’s

03 years

Rs.9280.00/1’s

14th DPCComplete address

of the manufacturer has been mentioned

on registration letter as per CoPP.

3. M/s. Novartis Pharma (Pakistan) Limited, Karachi./M/s. Salutas Pharma GmbH, Otto-von-Guericke, Germany.License Holder:-M/s. Hexal AG, Holzkirchen, Germany.

Ebetrexat 2.5mg TabletsEach tablet contains:-Methotrexate Disodium….2.75mg (equivalent to 2.5mg Methotrexate)(Anticancer Specialty)

Rs.403.43/Per 30’s

03 years

The firm is not interested in the

registration.

4. M/s. Novartis Pharma (Pakistan) Ltd, Karachi. /M/s. Ebewe Pharma Ges.m.b.H Nfg. KG MondseestraBe 11 AT-4866 Unterach Austria.

Folcium 50mg/5ml InjectionEach 5ml ampoule contains: -Folinic Acid as Calcium Folinate......50mg.

(Anticancer) not by FDA & EMA

Rs.1171.98/1’s 02 years

-do-


Folcium 100mg/10ml InjectionEach 10ml vial contains: -Folinic Acid as Calcium Folinate......100mg.(Anticancer Adjuvants)

Rs.2343.96/1’s 02 years

-do-



Folcium 300mg/30ml InjectionEach 30ml vial contains: -Folinic Acid as Calcium Folinate......300mg.(Anticancer)

Rs.7031.88/1’s 02 years

-do-

The firm later informed that they are only interested in registration of products at Sr. 1 &

2 above, and are not interested in the rest of the products.

Accordingly the registration letter of above 02 products have been issued, while the firms

intention for not getting registration of rest of the above products is submitted for consideration

of the Registration Board.

Decision:- As the product are important anti-cancer drugs, so the Board decided to ask firm the reason / clarification for withdrawing registration of these products.

Case No.13: Request For Change Of Manufacturer Of Clipper Tablet (Reg.No.066104) By M/S. Chiesi Pharmaceutical (Pvt.) Ltd, Lahore.

M/s. Chiesi Pharmaceuticals (Pvt.) Ltd; Lahore has applied for change of

manufacturer/manufacturing site for their following already registered imported human products,

as per details given below:-

S. No.

Reg. No. Name of Products. Existing Approved sites

New proposed site

1. 066104 Clipper TabletsEach tablet contains:-Beclomethasone Dipropionate ………. 5mg

M/s. Chiesi Farmaceutici S.p.A, Italy.

M/s. DOPPLE FARMACEUTICI S.R.L. con stabilimento sito in VIA MARTIRI DELLE FOIBE, 1-29016 CORTEMAGGIORE (PC) ITALIA.

The firm have deposited required fee of Rs.100, 000/- (Pages 60-61 & 83-84/Corr) and

submitted following supporting documents:-

i) Application on Form 5A.ii) Copies of initial registration letter and the firm had applied within the validity of

registration on 21-06-2011.


iii) Fresh original & legalized CoPP from authorities of Italy for proposed manufacturing site (Pages 100-102/Corr).

iv) Site master plan of the manufacturer.

The firm have deposited required fee of Rs.100, 000/- and submitted following supporting documents:-

i) Application on Form 5A.ii) Copies of initial registration letter and the firm had applied within the validity of

registration on 21-06-2011.iii) Fresh original & legalized CoPP from authorities of Italy for proposed

manufacturing site.iv) Site master plan of the manufacturer.

Decision: Registration Board deferred for confirmation of approval status in of formulation by regulatory authorities of reference countries.

Case No.14 Request for change of manufacturer of Seroxat Tablet 20mg (Reg.No. 019501) by M/s. GlaxoSmithKline Pakistan Limited, Karachi.

M/s. GlaxoSmithKline Pakistan Limited, Karachi has applied for change of

manufacturer/manufacturing site for their following already registered imported human products,

as per details given below:-

S. No. Reg. No. Name of Products. Existing Approved sites

New proposed site

1. 019501 Seroxat Tablet 20mgEach tablet contains:-Paroxetine HCl …… 20mg

M/s. S.C. Europharma S.A. Brasov Romania.

Product License holder / marketing authorization holder:M/s. Smithkline Beecham Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.Manufacturer /Packagers:M/s. Glaxosmithkline Pharmaceuticals S.A. Ulica Grunwaldzka 189, Poznan, PL-60-322, Poland.



i) Application on Form 5A.ii) Copies of initial registration letters & renewal status. (265-270/Corr).iii) Original & legalized CoPP from Medicine and Healthcare Products Regulatory

Agency of UK for proposed manufacturing site (Pages 272-297/Corr).iv) Site master plan of the manufacturer.


i) Application on Form 5A.ii) Copies of initial registration letters & renewal status. iii) Original & legalized CoPP from Medicine and Healthcare Products Regulatory

Agency of UK for proposed manufacturing site.iv) Site master plan of the manufacturer.

Decision:- Registration Board approved change of manufacturing site and product license holder of Seroxat Tablet 20mg (Reg.No. 019501) as under:-Product License holder:M/s. Smithkline Beecham Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.Manufacturer & Packagers:M/s. Glaxosmithkline Pharmaceuticals S.A. Ulica Grunwaldzka 189, Poznan, PL-60-322, Poland.

Case No. 15. Request of M/S. CCL Pharmaceuticals (Pvt.) Ltd., Lahore for change of manufacturing sites of their registered drug(s).

M/s. CCL Pharmaceuticals (Pvt.) Ltd., Lahore have requested to approve the change of

manufacturing site of their following registered imported anti-cancer products form M/s. Laboratorios

IMA S.A.I.C (Palpa 2870, CABA) Argentina to M/s. Glenmark Generics S.A. Calle 9 Ing Meyer Oks N° 593

(B1629MAX) Parque Industrial Pilar, Buenos Aires, Argentina:-

S. No. Reg. No. Name of drug(s) & Composition.1. 044851 Toxiplatin 150mg Injection

Each vial contains:-Carboplatin ……….150mg

2. 044852 Toxiplatin 450mg InjectionEach vial contains:-Carboplatin ……….450mg

3. 052286 Cytotecan Injection 40mgEach 2ml vial contains:-Irinotecan Hydrochloride Trihydrate 40mg


M/s. CCL Pharmaceuticals (Pvt.) Ltd., Lahore have deposited fee Rs.50,000 + 50,000 =

3,00,000/- and submitted following supporting documents:-

i) Copies of initial registration letters.ii) Copy of change of manufacturer name from M/s. Servycal S.A., Argentina to

M/s. Glenmark Generics S.A., Argentina. iii) Copies of last renewal.iv) Original and legalized approval from regulatory authority of Argentina.v) Copy of GMP Certificate.vi) Original & Legalized Certificate of Pharmaceutical Products.vii) Applications on Form 5-A.viii) Credentials of the Manufacturer.ix) Site Master File. x) Copy of NOC for CRF.

M/s. CCL Pharmaceuticals (Pvt.) Ltd., Lahore initially submitted Rs.50, 000/ per

products claiming that these are not available locally. However, later the firm has submitted the

balance fee Rs.50, 000/- per products also.

Decision: As the proposed change has been approved by the regulatory authority of exporting countries, so the Board approved change of manufacturing site of above products from M/s. Laboratorios IMA S.A.I.C (Palpa 2870, CABA) Argentina to M/s. Glenmark Generics S.A. Calle 9 Ing Meyer Oks N° 593 (B1629MAX) Parque Industrial Pilar, Buenos Aires, Argentina subject to inspection of manufacturer abroad as per policy on same terms & condition.

Case No.16: Request of M/s. Ghazi Brothers, Karachi for change of name of manufacturer/manufacturing sites of their registered drug(s).

M/s. Ghazi Brothers, Karachi has applied for change of name of manufacturers for their

following already registered products as under:-

S. No.

Reg. No.

Name of Drugs/Composition

Existing Name Requested changes

1. 046647 Neomix 325 Soluble Powder Each gm contains:-Neomycin Sulphate…….715mg(equivalent to Neomycin base 500mg)

M/s. Pfizer Suzhou Animal Health Products Co. Ltd., China.

M/s. Zoetis Suzhou Manufacturing Co. Ltd., No.180 Zhu Yuan Road, Suzhou New District, Jiangsu, China.


2. 044992 Excede InjectableEach ml contains:-Ceftiofur crystalline free acid equivalent to 200mcg Ceftiofur in a Miglyol and cottonseed oil based suspension

M/s. Pharmacia & Upjohn Company, Subsidiary of Pfizer Inc. USA.

M/s. Zoetis Inc.2605 East Kilgore Road, Kalamazoo, Michigan, 49007, USA.

The firm has further requested for change of manufacturing site of their registered products

Draxxin Injection as per following details:-

S. No.

Reg. No.

Name of Drugs/Composition

Existing Source Requested/proposed changes

1. 044919 Draxxin InjectionEach ml contains:-Tulathromycin….100mgMonothioglycerol…5mg

M/s. Pfizer Global Manufacturing, France.

M/s. Laboratorios Pfizer Ltda Guarulhos, Avenida Presidente Tancredo de Almeida Neves, 1555 Guarulhos, SP P.P. Box 017112-070 Brazil.

The firm have deposited required fee Rs.100,000 x 3 = Rs.300,000/- and submitted following

supporting documents:-

i) Application on Form-5A.ii) Copies of initial registration letters. iii) Copies to renewal status. iv) Original & Legalized CoPP's for Neomix 325 Soluble Powder (China), for Excede In-

jectable (USA) for Draxxin 100mg injection (Brazil) v) Copy of GMP Certificate for Neomix 325 Soluble Powder) for Excede Injectable &

for Draxxin 100mg injection.vi) NOC for (Draxxin 100mg Injection).vii) Site master plans of concerned firms (Draxxin 100mg injection).

Decision: Registration Board decided as under:-

i. For Neomix 325 Soluble (Reg.No.046647), approved change of the name of manufacturer from M/s. Pfizer Suzhou Animal Health Products Co. Ltd., China to M/s. Zoetis Suzhou Manufacturing Co. Ltd., No.180 Zhu Yuan Road, Suzhou New District, Jiangsu, China on same terms & conditions.

ii. For Excede Injectable (Reg.No. 044992), approved change of the name of manufacturer from M/s. Pharmacia & Upjohn Company, Subsidiary


of Pfizer Inc. USA to M/s. Zoetis Inc. 2605 East Kilgore Road, Kalamazoo, Michigan, 49007, USA on same terms & conditions.

iii. For Draxxin Injection (Reg.No. 044919), approved the change of manufacturing site from M/s. Pfizer Global Manufacturing, France to M/s. Laboratorios Pfizer Ltda Guarulhos, Avenida Presidente Tancredo de Almeida Neves, 1555 Guarulhos, SP P.P. Box 017112-070 Brazil subject to inspection of manufacturer abroad on same terms & conditions.


Registration-IV

Case No.17: Registration of Drugs For Export Purpose.

The following firm has applied for registration of drugs for the purpose of export only:-

S. # Name of Manufacturer

Name of Drug (s)/Composition.

1 M/s. Fassgen Pharmaceuticals,

Hattar

Valdis TabletsEach film coated tablet contains:-Ledipasvir…………………90mgSofosbuvir……………….400mg

The firm submitted all the relevant documents along with the fee of Rs.20,000/- per

product and requested for registration of drugs for export purpose only.

Decision: Registration Board approved above product for export registration. However firm will deposit remaining balance Fee of Rs. 30,000/- and Chairman, Registration Board will permit issuance of registration letter. Registration is subject to following conditions:

Manufacturer will export the product after complying all the requirements as required under Drug Act, 1976 and relevant rules including No objection certificate from concerned DRAP office.

Manufacturer will also furnish export documents endorsed from custom authorities (if required for any query) in order to ensure the export of the product.

Case No.18: Request of M/s. Welmed Pharmaceuticals Gadoon for extension in contract manufacturing permission.

Registration Board in 254th meeting deferred following application of M/s. Welmed

Pharmaceuticals Gadoon Swabi for extension of contract manufacturing period (where contract

manufacturer was also changed) for confirmation of already extended contract manufacturing

permissions.


S.No Name of Applicant

Existing manufacturer

Reg.No Name of Product Date of applications/Fee

Remarks

1. M/s. Welmed Pharmaceutical Gadoon Swabi.

M/s. Welmark

Hattar

056233 W-Pime 500mg InjectionEach vial contains:-Cefipime….500 mg(USP Specification)

30-06-2015Dy No.66Rs.50,000/-

30-06-2015Firm hasrequested

forchange ofcontract

manufacturerto Bio-Lab (Pvt) Ltd., Islamabad

2. -do- -do- 056234 W-Pime 1 gm InjectionEach vial contains:-Cefipime…………1 gm(USP Specification)

30-06-2015Dy No.69Rs.50,000/-

-do-

3. -do- -do- 056238 Mectrum 1gm InjectionEach vial contains:-Cefoperazone Sodium ≡ Cefoperazone.500 mgSulbactam …….500mg(Welmark Specification)

30-06-2015Dy No.68Rs.50,000/-

-do-

4. -do- -do- 056239 Mectrum 2 gm InjectionEach vial contains:-Cefoperazone Sodium ≡ Cefoperazone.1000 mgSulbactam ….1000mg(Welmark Specification)

30-06-2015Dy No.67Rs.50,000/-

-do-

The firm subsequently requested that they would like to exclude the products Medifotax

Injection 500mg & 1gm, contract manufacturing permission for which has already been given

from M/s. Mediate Pharmaceuticals, Karachi and they may be granted extension/change of

manufacturer permission of above products instead. The case was considered in 258 th meeting

and deferred on the ground that the firm has not made any specific request for withdrawal /

cancellation of their products Medifotax Injection (500mg & 1gm), so matter needs to be

clarified from the firm. The case is accordingly deferred.

Now the firm stated to cancel the registration of Medfotax Injection (Cefotaxime 500mg,


1gm) (Reg.No. 056228, 056229) and issue the extension letter of above mentioned drugs.

The firm has only two Sections and it, therefore, entitles to contract manufacturing of 10

products as per policy of 5 products per section. So far the firm has been granted registration of 8

products.

Decision: Registration Board did not agree to the firm’s proposal for withdrawal / cancellation of their already registered two products for making way to get the approval of fresh one as replacement. The Board further decided to allow permission for extension of contract manufacturing alongwith change of manufacturer (from M/s. Wnsfeild Pharmaceuticals Hattar to M/s. Bio-Labs, Islamabad) for only two of the above mentioned products of firm choice till 30.06.2020. The Chairman Board was authorized to allow issuance of permission letter after taking firm’s choice for the products.

Case No.19: Registration of Frodine Syrup.

Registration Board in 243rd meeting held on 9th May, 2014 deferred following drug of

M/s. Wisdom Pharmaceuticals, Peshawar for confirmation of controlled drug section and

international availability of the product

1M/s. Wisdom

Pharmaceuticals, Peshawar

Frodine SyrupEach 5ml contains:-Pholcodine……………….….5mgChlorpheniramine Maleate…..2mg

Registration Board in 250th meeting considered the comments of review committee and decided as under:-

International availability Remarks

BRONCALENE ADULTES chlorphénamine (maléate de) ; pholcodine 0,01300g/100 ml (0.65mg/5ml); 0,08g/100ml (4mg/5ml) Oral Syrup

Chlorphénamine (maléate de) ; pholcodine Adults: Dose: 0.01300g/100 ml (0.65mg/5ml); 0.08g/100ml (4mg/5ml) 0.0133gm/100ml (0.665mg/5ml); 0.08g/100ml (4mg/5ml) (sugar free sweetened with saccharine sodium) Children: 0.01gm/100ml (0.5mg/5ml); 0.05g/100ml (2.5mg/5ml) (Ref: ANSM France)


Decision of 250th Registration Board meeting :

i. Applicants shall shift their formulation as per formulation approved in ANSM France (new registration application with complete fee) if manufacturing facility is approved by CLB.

ii. For already registered drugs, same procedure as mentioned above (at Sr. No. i) shall be adopted.Otherwise show cause notices shall be issued for deregistration of drugs in this formulation.

iii. All such application shall be processed on priority basis.

Now M/s. Wisdom Pharmaceuticals Peshawar has made an application with the revised

formulation alongwith complete fee of Rs.20000/- . The revised formulation is as under:-

1 M/s. Wisdom Pharmaceuticals,

Peshawar

Frodine SyrupEach 5ml contains:-Pholcodine……………….….4mgChlorpheniramine Maleate…..0.65mg

Decision: Registration Board decided to approve the change in formulation of Frodine Syrup in accordance with the revised standard formulation.

Case No.20: Request of firms for issuance of registration of deferred drugs.

The following registration applications of various firms were deferred by Registration

Board meetings in its 234th meeting for the reason mentioned against each.

1. M/s. Winbrain Research Laboratories, Hattar1. Tablet General2. Caps General,3. Dry powder Susp General

Razole 20mg TabletsEach tablet contains:-Omeprazole…….20mg(Proton Pump Inhibitor)

10’s As Per SRO

Deferred as per policy of 5 products per section for new license/new section (product is recommended by the me-too committee)

2. -do- Diclo-K 50mg TabletsEach tablet contains:-

2x10’s

As Per SRO

Deferred as per policy of 5 products per section for new


Diclofenac Potassium……50mg(Analgesic)

license/new section (product is recommended by the me-too committee)

3. -do- Diclo-K 75mg TabletsEach tablet contains:-Diclofenac Potassium……75mg

2x10’s

As Per SRO


4. -do- Pepzole 40mg TabletsEach tablet contains:-Pantoprazole (as Sodium Sesquihydrate)…40mg

14’s As Per SRO


5. -do- Lodepress 20mg TabletsEach tablet contains:-Paroxetine as HCl…..20mg(Antidepressant)

10’s As Per SRO


6. -do- Am-Telma 5/40mg tabletsEach tablet contains:-Amlodipine………5mgTelmisartan……..40mg(Antihypertensive)

14’s As Per SRO


7. -do- Loxit 60mg CapsulesEach capsule contains:-Duloxetine as HCl….60mg(Antidepressant)

10’s14’s

As Per SRO


8. -do- Gabapen 300mg CapsulesEach capsule contains:-Gabapentin……100mg(Anticonvulsant)

10’s As Per SRO


9. M/s. Weather Folds Pharmaceuticals, Hattar1. Dry powder Susp General,2. Caps, General

G-Pentin 300mg CapsuleEach capsule contains: -Gabapentin …… 300mg(Analgesic)

10’s -do- Deferred as per policy of 5 products per section for new license/new section (product is recommended by the me-too committee)

10. -do- Effexor 75mg Capsule 10’s -do- Deferred as per policy of 5


Each capsule contains:-Venlafaxine HCl 75mg(Psychotherapeutic)

products per section for new license/new section (product is recommended by the me-too committee)

11. -do- Tizadine 6mg CapsuleEach capsule contains:-Tizanidine …….. 6mg(Muscle relaxants)


12. -do- Helcobal 500mcg CapsuleEach capsule contains:-Mecobalamine. 500mcg(Coenzyme-type vitamin B12)

10’s10x10’s

-do-` Deferred as per policy of 5 products per section for new license/new section (product is recommended by the me-too committee)

13. -do- Floxapen 250mg CapsuleEach capsule contains:-Flucloxacilline .. 250mg(Pencillin)


14. -do- D-Lox 30mg CapsulesEach capsule contains:-Duloxetine as HCl.30mg(Antidepressant)

14’s As Per SRO

Approved

15. -do- D-Lox 60mg CapsulesEach capsule contains:-Duloxetine as HCl.60mg(Antidepressant)

10’s14’s

As Per SRO

Deferred as per policy of 5 products per section for new license/new section. (product is recommended by the me-too committee)

16. -do- Artham DS CapsuleEach capsule contains:-Artemether …… 40mgLumefantrine ….. 240mg(Anti-malarial)


17. -do- Ciprofold 250mg CapsuleEach capsule contains:-Ciprofloxacin as HCl. 250mg

(Anti infective Quinolones)


18. -do- Tranxam 500mg Not -do- Deferred as per policy of 5


CapsuleEach capsule contains:-Tranexamic acid.. 500mg

mentioned

products per section for new license/new section (product is recommended by the me-too committee)

19. -do- Tranxam 250mg CapsuleEach capsule contains:-Tranexamic acid.. 250mg(Antifibrinolytic)

Not mentioned

-do- Deferred as per policy of 5 products per section for new license/new section (product is recommended by the me-too committee)

20. -do- P-Zole 40mg CapsuleEach capsule contains:-Pantoprazole…… 40mg(Antipeptic ulcerants)


21. M/s. Welwrd Pharmaceuticals, Hattar1. Dry Powder Inj. Sterile2. Tablet General3. Capsule General4. Dry Powder Suspension General5. Sachet General

Artiwel 280mg TabletsEach tablet contains:-Artemether……….40mgLumefantrine……240mg(Antimalarial)

8’s As Per SRO


22. -do- Estowel 10mg TabletsEach tablet contains:-Escitalopram (as oxalate).10mg(Anti Psychotic)

10’s14’s

As Per SRO

Deferred as per policy of 5 products per section for new license/new section (product is recommended by the me

23. -do- Weldiclof 100mg SR TabletsEach film coated tablet contains:-Diclofenac SR …..100mg(NSAID)

2x10’s

As Per SRO


24. -do- Lansowel 30mg Capsules

14’s As Per SRO

Approved with fulfillment of requirements of source, GMP


Each capsule contains:-Lansoprazole Pellets equivalent to Lansoprazole…30mg(Proton Pump Inhibitor

certificate, stability data and Fee. Rs.15000/-

25. -do- W-Pentone InjectionEach vial contains:-Thiopentone Sodium ..5.00mg(Anesthetic agent)

Per vial

As Per SRO

Highly sensitive product. Product specific inspection is recommended by the experts.

26. -do- Zimtac 250mg Injection I.VEach vial contains:-Cefotaxime sodium equivalent to Cefotaxime……..250mg(Cephalosporin)

Per vial

As Per SRO


27. -do- Zimtac 500mg Injection I.VEach vial contains:-Cefotaxime sodium equivalent to Cefotaxime……..500mg(Cephalosporin)

Per vial

As Per SRO


28. -do- Zimtac 1gm Injection I.VEach vial contains:-Cefotaxime sodium equivalent to Cefotaxime……..1gm(Cephalosporin)

Per vial

As Per SRO


29. -do- Weltraxone 250mg Injection IVEach vial contains:-Ceftriaxone Sodium equivalent to Ceftriaxone ……250mg(Cephalosporin)

Per vial

As Per SRO


30. -do- Weltraxone 500mg Injection IVEach vial contains:-

Per vial

As Per SRO

Deferred as per policy of 5 products per section for new license/new section (product is


Ceftriaxone Sodium equivalent to Ceftriaxone ……500mg(Cephalosporin)

recommended by the me-too committee)

31. -do- Weltraxone 1gm Injection IVEach vial contains:-Ceftriaxone Sodium equivalent to Ceftriaxone …1gm(Cephalosporin)

Per vial

As Per SRO


In 234th meeting the Board adopted 5 products per section policy and 5 products per section of

each firm were accordingly approved while rest of the applications were deferred. Subsequently

in 236th meeting 5 more products per section per firm were approved among the products

deferred in 234th meeting. The above products are the remaining applications which were left

after the approval of 10 products (in 234 & 236th meeting) as mentioned above paras.

The firms have requested for issuance of registration letters for the products at S.No.1-25

while for the products at S.No.26-31, the applicant M/s. Welwrd has not made any request.

As per record of the section number of registration granted to various sections of the above

firms is as under:-

Name of Firms Section Already registered

M/s. Winbrain Reserch Labs Capsules 8 products

M/s. Weather Fold Capsule 10 products

M/s. Welwrd Pharmaceuticals,

Tablets

Liquid Injectable

Capsule

10 products

10 products

8 products

Decision: Registration Board in principal agreed to allow two products in Capsule Section of M/s. Welwrd Pharmaceuticals, Hattar from among their above


applications. The choices for the products are to be taken from the firm before placing the case for consideration of the Board for final decision. Remaining products will be taken up as per their turn.

The case of applications of M/s. Winbrain Research Laboratories, Hattar was discussed alongwith following case No.21 and decision is recorded there in.

Case No.21 Request of M/s. Winbrain Research Laboratories, Hattar for issuance of registration letter.

M/s. Winbrain Research Laboratories, Hattar has requested for issuance of registration

letters of their following product approved in 234th meeting of Registration Board with conditions

mentioned against each .

S.No Name of Manufacturer

Name of Products Pack size

Demanded MRP

Dated Decision of Registration Board

1. M/s. Winbrain Research Laboratories, Hattar1. Tablet General2. Caps General,3. Dry powder Susp General

Brainzole 30mg CapsulesEach capsule contains:-Lansoprazole Pellets equivalent to Lansoprazole…..30mg(Proton Pump Inhibitor)

14’s As Per SRO

2-6-2011

Approved with fulfillment of requirements of source, GMP certificate, stability data and Fee. Rs.15000/-

2. -do- Esobrain 20mg CapsulesEach capsule contains:-Esomeprazole Pellets equivalent to Esomeprazole….20mg(Proton Pump Inhibitor)

14’s As Per SRO

-do- Approved with fulfillment of requirements of source, GMP certificate, stability data and Fee. Rs.15000/-

3. -do- Omebrain 40mg CapsulesEach capsule contains:-

14’s As Per SRO

-do- Approved with fulfillment of requirements of


Omeprazole Pellets equivalent to Omeprazole……..40mg(Proton Pump Inhibitor)

source, GMP certificate, stability data and Fee. Rs.15000/-

4. -do- Loxit 30mg CapsulesEach capsule contains:-Duloxetine as HCl….30mg(Antidepressant)

14’s As Per SRO

-do- Approved

The registration letter was not issued as the firm has not fulfillment the requirements while the

product as S.No.4 was referred for price fixation. The firm has now requested to issue registration

letter by providing the documents referred in the minutes. Moreover the price of product as S.No. 4

has also been fixed.

The firm already has registration of 8 products in the capsule section.

Decision: Registration Board in principal agreed to allow two products in capsule section of M/s. Winbrain Research Laboratoire, Hattar from among their above applications (referred in the instant case and case No.20). The choices for the products are to be taken from the firm before placing the case for consideration of the Board for final decision. Remaining products will be taken up as per their turn.


Registration-V

Case No.22: Export of Non Me-Too Product

a. M/s. Highnoon Laboratories Ltd, Lahore

M/s. Highnoon Laboratories Ltd, Lahore has requested for registration of following product for export purpose only:-

S. No Name of Products

1. Daploz 5mg TabletsEach film coated tablet contains:Dapagliflozin propanediol monohydrate equ to;Dapagliflozin…………..5mg

2. Daploz 10mg TabletsEach film coated tablet contains:Dapagliflozin propanediol monohydrate equ to;Dapagliflozin……….…..10mg

3. Cana 300mg TabletsEach film coated tablet contains:Canagliflozin hemihydrates equivalent to;Canagliflozin…..……….300mg

4. Cana 100mg TabletsEach film coated tablet contains:Canagliflozin hemihydrates equivalent to;Canagliflozin…..……….100mg

5. Daclata 60mg tabletsDaclatasvir dihydrochloride equ to:-Daclatasvir……………...60mg

6. Daclata 30mg tabletsDaclatasvir dihydrochloride equ to:-Daclatasvir……………..30mg

The firm has submitted the following documents. a. Fee of Rs. 50000/- each product for this purpose. b. Form-5.

c. Copy of GMP inspection.d. Export orders.c. NOC for CRF.e. Approval of section by CLB.


Decision: Registration Board approved grant of above registrations exclusively for export purpose. Registration is subject to following conditions:


Manufacturer will also furnish export documents endorsed from custom authorities (if required for any query) in order to ensure the export of the product

b. M/s. CCL Pharmaceuticals (Pvt) Ltd , Lahore

M/s. CCL Pharmaceuticals (Pvt) Ltd , Lahore has requested for registration of following product for export purpose only:-

S. No Name of Products

1. Carci Suspension 500mg/5mlEach 5ml contains:Carbocisteine…………..500mg

2. Carci Suspension 200mg/5mlEach 5ml contains:Carbocisteine…………..200mg

3. Carci Capsule 500mgEach Capsule contains:Carbocisteine…………..500mg

The firm has submitted the following documents. a. Fee of Rs. 50000/- each product for this purpose. b. Form-5.

c. Copy of GMP inspection.d. Export orders.c. NOC for CRF.e. Approval of section by CLB.

Decision: Registration Board approved grant of above registrations exclusively for export purpose. Registration is subject to following conditions:


Manufacturer will also furnish export documents endorsed from custom authorities (if required for any query) in order to ensure the export of the product


Case No.23 Registration applications of M/S Gallop Water Sciences, Lahore deferred in 253rd meeting of Registration Board.

Following applications of M/s Gallop Water Sciences, Lahore were deferred in 253rd

meeting of registration board

1. G-SOL PAEDSIV InfusionEach 100ml contains:Dextrose anhydrous….4.3gSodium Chloride……..0.18gCaloric & Electrolytic solution

Form-5Dy. No: 3472dated 18-05-201520,000/-Rs.50/- Rs.40/- 500ml, 200ml

• Int availability not confirmed.Me-too: Macsol

Paeds of M/s Mac & Rains Lahore.

Deferred for confirmation of approval by reference regulatory authority.

2. G-Lyte MIV InfusionEach 100ml contains:Sodium Chloride……..0.216gmPotassium Chloride…..1.5gmCalcium Chloride 2 H2O …..…0.022Sodium Acetate 3 H2O …0.313gmDextrose………..5.0gmElectrolytic & Caloric solution

Form-5Dy. No: 3473dated 18-05-201520,000/-Rs.100/- Rs.70/- 1000ml, 500ml,

Internationally, not available in this strength.

Me-too: Plabolyte-M of M/s Otsuka, Karachi


3. MannitolIV InfusionEach 100ml contains:Mannitol…….17.5gmSorbitol…….2.5gmOsmotic diuetic

Form-5Dy. No: 3458dated 18-05-201520,000/-Rs.200/- 500ml

Internationally Not available in this strength

Me-too: Mactol of M/s Mac & Rains, Lahore


Subsequently the firm requested for replacement of above applications with the following

new ones which were presented in 255th meeting of the board. Case was decided as follows:


566 G-SOL 10%

Each 100 ml contains

Dextrose anhydrous 10gm

Caloric solution

(Manufacture Specification)

Form 5

Rs. 20,000/- vide Dy. No. 1140 dated 06-11-2015

Pack size of 1000ml / 70 PKR

Otsuka Japan formulation (Pladix)

FDA approved Dextrose 10%

Medisol 10% (Medipak)

The Board deferred the application for clarification whether the firm wants to withdraw their previously deferred application in view of the newly submitted applications or otherwise.

567 G-SOL 5%


Dextrose anhydrous 5gm

Caloric solution


Form 5



Otsuka Japan formulation (Pladix)

FDA approved Dextrose 5%

Medisol 5% (Medipak)


568 G-Sol RL 500 ml


Sodium Chloride 0.60gm

Potassium Chloride 0.04gm

Calcium Chloride 0.027gm

Form 5



MHRA approved

Medisol Hartmann IV infusion



Sodium lactate 0.32 gm

Electrolyte Solution


(Medisol )

The firm has requested that the registration of the products deferred in 253rd meeting may

be considered in routine as per DRAP Policy and two products may be processed on priority

basis against the quota of ten products per section. This request of the firm was considered in

257th meeting of registration board and following decision was taken:-

Decision: Registration Board acceded to the request of the firm and approved products at serial no. 559 and 560 whereas product at serial no 558 was deferred for clarification whether the firm wants to withdraw their previously deferred application in view of the newly submitted applications or otherwise.

It is submitted that a typographic error was made in the minutes of 257th registration

board meeting and products at Sr no. 559 and 560 was mentioned inadvertently instead of

product at Sr. No 567 & 568. The firm has been issued registration letter with correction in

minutes.

Decision: Registration Board noted the information and endorsed the action taken.

Case No.24: Pending registration of Vinqo 500mg & 1gm Injection of M/s Wilshire Laboratories (Pvt) Ltd, Lahore.

Registration Board in 258th meeting discussed the following case of M/s. Wilshire

Laboratories (Pvt) Ltd, Lahore. Following products of M/s Wilshire Laboratories (Pvt) Ltd,

Lahore were discussed in 236th meeting of Drug Registration Board but deferred for further

clarification about manufacturing facility. Then the case was included in 243rd meeting of the

board again deferred for further clarification about the manufacturing facility.

S.No Product Name Generic Name Date of Submission

Remarks


1 Vinqo 500mg inj Vancomycin Hydrochloride 500mg

04.06.2011 Applied as a new section product

2 Vinqo 1gm inj Vancomycin Hydrochloride 1gm

04.06.2011 Applied as a new section product

Registration Board its 243rd meeting discussed the case and for further deliberation on

manufacturing area requirements.. Registration Board in its 248th meeting decided the

manufacturing Area requirement for Vancomycin:

“As it is not a Penicillin Derivative, hence manufacturers, having in-house lyophilization facilities, may be allowed to produce it in General Injectable Area”

Decision: Registration Board deferred the case for getting details of manufacturing process of the applicant and to decide the case in the light of decision taken by the board in 248th meeting.

The above decision needs to be reconsidered as Registration Board in 257th meeting has

granted the same registration to M/s. Fynk Pharma, Lahore and referred decision of 248 th

meeting of the board is not the same as depicted in 258th meeting of the board. Rather, board in

2418th meeting had deferred the product for further deliberations.

Decision: Regsitration Board approved the above drugs in favour of M/s Wishire

Laboratories (Pvt) Ltd, Lahore.

Case No.25: Change of brand name for Epinol CF tablet of M/s. CCL Pharmaceuticals

(Pvt) Ltd; Lahore

M/s. CCL Pharmaceuticals (Pvt) Ltd: Lahore has requested for change of brand name of their

following product and they have informed that the proposed brand name already in syrup form:-

S. No. Names of Drug(s) with formulation

Reg. No. New proposed names

1. Epinol CF TabletEach tablet contains:Paracetamol……………500mgPseudoephedrine HCl….60mgChlorpheniramine Maleate……….4mg

023982 Pulmonol CF Tablet

The management of the firm has submitted following documents:


i. Fee of Rs. 20,000/- for each product.ii. Undertaking on stamp paper.iii. Copies of initial letter of registration & renewal status.iv. CRF clearance certificate.

It is submitted that the composition of Epinal tablets as mentioned above is different form

pulmonol syrup. Composition of pulmoul is as under.

S.No. Reg. No Name of Product with composition

1 000874 Pulmonol SyrupEach 5ml Contains:-Chlorpheniramine maleate B.P……5mgTerpin Hydrate USP……………….10mgPotassium Bicarbonate B.P………...0.1mgAmmonium Chloride B.P…………..25mgMenthol B.P………………………...1mgAminophylline Ph.Eur………………32mgPotassium guaiacol sulfonate U.S.P…...5mgPotassium citrate B.P………………..0.1mgTr. Senega B.P……………………….0.05mlTr. Ipecac B.P………………………...0.025mlExtract Glycyrrhiza b.P………………..0.1mlFlavor & Base……………..q.s

Decision: Registration Board considered the request of the firm in the light of SOPs / guidelines for change of brand name of the drugs and did not accede to the request as composition of formulation of the drug (Epinol CF Tablet) was different from the composition of Pumonol Syrup.

Case No.26: Registration of M/S N.B.S Pharma, Lahore

Following products of M/s N.B.S Pharma, Lahore were considering 215 th meeting of

registration board and decided as follows.

Sr.No Name of Drug Decision1. Povidone-1 Solution

Each 100ml contains:-Povidone Iodine USP 7.5gm equivalent to 0.75% available iodine (USP)

Approved subject to the submission of the last Inspection report.

It is submitted that the above cases were discussed in 215 th meeting of registration board

and decision of the board has been reflected in the above table. The firm has now submitted the


differential free of Rs. 12000 and submitted the inspection report dated 12.11.2014. which

shows details of the section as under:-

External Preparation Section:-

This section comprised of preparation and filling rooms, equipped with preparation vessels of different sizes. Silver san mixer and filling machines was installed HVAC system was provided in this area and was functional at the time of inspection. Re-packing area was equipped with filling machine and different size vessels. HVAC system was installed production area furnish with epoxy.

Decision: Registration Board deferred the case for GMP status of the firm and confirmation of section either from Licensing division or from panel / renewal inspection report.

Case No.27: Registration of M/s Chishti Pharma ; Sahiwal

M/s Chishti Pharmaceuticals Industries, Sahiwal has requested to issue following

registration approved in 206th meeting.

Sr.No Name of Drug Decision1. Imperial Crepe Bandage.

Contains:-Crepe Bandage BPC.

Approved.

The firm has submitted following documents :-

i. Copy inspection report (GMP)ii. Copy of Bank challan of Rs. 8000/-iii. Differential fee of Rs. 12000/-as balance fee.

Decision: Registration Board deferred the case for submission of new Form-5 and verification of record regarding issuance of registeration letter, as product was considered by Registration Board in 2007.

Case No.28: Registration Of M/S Schazoo Pharma, Lahore.


M/s the Schazoo Pharmaceuticals Laboratories (Pvt) Ltd, Sheikhupura had requested for

permission to export drugs containing precursor Chemical Ephedrine to M/s. Rahullah Nasrat Limited,

Afghanistan as detail below:-

S.No Name and composition Reg. No Pack Size Quantity requested to export

Quantity of Ephedrine

1. Rhinosone-P Nasal Spray Each 100ml Contains:-Naphazoline Nitrate…..125mgEphedrine HCl…..500mgPrednisolone Acetate….2.5mg

040892 15ml 50000 Bottles 3.75-kg

2. Rhinosone-P Nasal Spray Each 100ml Contains:-Naphazoline Nitrate…..125mgEphedrine HCl…..500mg9 alpha- Fluoro Prenisolone 21-Acetate….2.5mg

000834 15ml 100000 Bottles

7.5-kg

The firm was asked for the clarification of the both compounds of Prednisolone . They

have replied with official reference i.e. The USP monograph of 9 Alpha-Floropredinsolone

Acetate shows it is an veterinary drugs but the ear drops applied by the firm are for human

consumption.Moreover, the subject formulation is not available in reference regulatory

authorities as specified by the board in 249th meeting.

Decision: Registration Board deferred the case for further deliberation and presentation by the firm before Registration Board.

Case No. 29: Registration of M/S Dyson, Lahore


M/s. Dyson Pharma, Lahore has requested to issue following registration considered in

236th meeting.

Sr.No Name of Drug Decision1 Dyprog Tablets 5mg

Each tablet contains:-Norethisterone….5mgB.P Specs

Approved subject to submission of comparative dissolution profile and related documents. The firm shall be granted non-anabolic steroids in this section.

2 Dyston Tablets 10mgEach film coated tablet contains:-Dydrogesterone….10mgUSP Specs

-do-

3 Dyestro Tablets 0.625mgEach film coated tablet contains:-Conjugated Estrogens …..0.625mgUSP Specs

-do-

4. Dyestadiol TabletsEach film coated tablet contains:-Cyproterone acetate….2mgEthinylestradiol….35mcg

-do-

The firm has submitted following documents:-

i. Differential Fee of Rs. 12000/per productii. Comparative dissolution profileiii. Undertaking as per decision of Registration Board in 251st meeting.

Decision: Registration Board deferred the case for further deliberation in next meeting.

Case No.30: Registration application of M/s. English Pharmaceutical, Lahore deferred in 241st meeting.


Registration Board in 241st meeting discussed the case of M/s English Pharma, Lahore

and decided as follows:-

M/s. English Pharmaceuticals Industries, Lahore were deferred in its 237th meeting for

verification of complete formulation with originator (Detrusitol Capsule SR 4 mg by Pfizer) and

Comparative Dissolution profile with originator.

Name of products & Composition Pack size

Demanded price

Terol 4mg SR CapsulesEach capsule contains:-Tolterodine HCl equiv. to Tolterodine SR…4mg

3×10’s Rs.2300/-

The firm has provided following documents:-

1. Comparative dissolution profile. 2. Sample of Detrusitol Capsule SR 4 mg by Pfizer confirming that product is I pellet

form 3. GMP certificate of manufacturer.4. Stability studies.5. Certificate of analysis.

Decision (241 meeting): - Registration Board deferred the submitted data to following experts for

evaluation and authorized its Chairman for decision on recommendation of experts:

I. Prof.Dr.mehmood Ahmad, Islamia university, BahawalpurII. Prof.Dr.Zafar Iqbal, University of Peshawar.

III. Director DTL, Lahore.

In view of above, experts have furnished comments as under:-

S.NO Name of the drugs with composition

Comments of the experts

1. Mr. Jamil Anwar Director, Drugs Testing Laboratory, Lahore

As per information/ data provided by M/s. English Pharmaceutical industries Lahore for registration of the product Terol (Tolterodine HCl to Tolterodine 4mg) SR Capsule, the standard Analytical Procedures for the finished product has been studies. The stability data foe


accelerated stability program (6 Months) and long term stability program (12 months) has been performed for 1,3 and after 7 hours dissolution profile. The study has been carried out by M/s. Heterol, India.The comparative study with the brand leader i.e. M/s Pgizer’s product- Detrusitol 4mg SR capsules, Bach No A..1566F, carried out by M/s. English Pharmaceutical Industries, Lahore with the comparable results at 01,1 and after 7 hours.The Good Manufacturing Practices (GMP), dated 22.08.2012 for M/s. Heterol, India is attached with information/ data provided by M/s. English Pharmaceuticals industries, Lahore.In the light of above and as per data/ information provided, the registration of “Terol 4mg SR Capsule” is recommended subject to the provision of Good Manufacturing Practices of M/s English Pharmaceutical, Lahore, and the firm may be directed to submit the dissolution profile of Terol 4mg SR Capsules before marketing.

Dr. Mehmood Ahmad, Islamia University Bahwalpur.

Granules with white to off white colour were seen in enclosed gelatin shells upon physical examination. Dissolution studies were conducted in USP type-1 basket with rotation speed of 100 ± 4rpm at 37± 2°C. Standard solution was made in mobile phase comprising of buffer solution and acetonitrile. Stability studies i.e real time at 30°± 75% RH for 2 years and accelerated at 40°C ± 75% RH for 06 month were conducted. During stability testing various parameters were evaluated like physical description, identification via HPLC chromatogram, dissolution testing and assay. Product passed all aforementioned parameters and remained stable during the stability period.Therefore, based on the presented results it is recommended that the capsule Terol 4mg can be registered.

3. Dr Zafar Iqbal Reply Awaited

Decision: Registration Board deliberated the reports and deferred the case for opinion of Prof.Dr.Mehmood Ahmad regarding use of basket system for performing


dissolution studies instead of paddle system and to issue reminder to Dr. Zafar Iqbal for furnishing expert opinion.

Case No.31: M/s Feroza International Lahore- Extension of contract manufacturing.

M/s Feroza International Lahore has informed that their below mentioned products were

approved in 212th meeting of registration board but letter was not issued. The firm has requested to

grant extension.

Sr No.

Name of Drug

1 Leetab Infusion 500mgEach vial contains:-Levofloxacin…………………….500gm

2 Haemofer 200mg InjectionEach 5ml Contains:-Iron as iron sucrose……………..200mg

3 Neuramin 500mcg injectionEach ml contains:-Mecobalamine…………..500mcg

Following documents have been submitted. Fee of Rs: 50,000 per product. Form -5 with contract agreement with M/s English Pharma, Lahore. Copy of contract agreement between two parties. GMP certificate of M/s English Pharma, Lahore.

It is submitted that the above products of the firm were approved in 212 meeting and extension

was granted till 30.6.2010. However, the form did not apply for extension for the further period.

Now the firm has requested to grant approval for extension under new toll policy for the period

of five years.

Decision: Registration Board deferred for confirmation of composition of applied products at S.No.02 and confirmatuion from record regarding non-issuance of registration letters as claimed by the firm.


Pharmaceutical Evaluation Cell

Out of Queue Applications for New Molecule, Anticancer, HIV Aids and other life saving drugs.

Registration Board in 257th meeting decided to consider registration applications of

various classes of drugs on priority. Decision is as follows:

“Registration Board deliberated that drugs for treatment of chronic ailments and drugs which are in short availability should have priority review process and consideration by the Board to ensure their free availability. The Board decided that drugs for treatment of cancer, viral diseases, thalaesemia, immunosuppresants, vaccine and sera, new molecules / formulations, blood factors and bags will be given priority consideration.”

Registration Board considered (out of queue) following registration applications as

evaluated by Pharmaceutiacl Evaluation Cell. However the Board advised to inform DRAP’s

Policy Board regarding above mentioned decision.

List of human imported drugs Anticancer, Immunosuppressant, New molecules and Blood

bags applications with complete fee.

Muhammad Ansar Evaluator-I (PEC)

S/N Name and address of manufacturer / Applicant

Brand Name(Proprietary name + Dosage Form + Strength)CompositionPharmacological GroupFinished product Specification

Type of FormInitial date, diary Fee including differential feeDemanded Price / Pack size

Remarks on the formulation (if any) including International status in stringent drug regulatory agencies / authorities Me-too status GMP status as depicted in latest inspection report (with date) by the Evaluator

Remarks of the Evaluator.

Decision

1. M/s. AJ Mirza Emeset 4mg/2ml Form -5-A MHRA.Ondan COPP Approved


Pharma (Pvt) Ltd., Karachi. /

Manufactured ByM/s Cipla Ltd D.P Pally (Narsapur Road). Near Gandimaisamma X Road, Hydarabad India

Injection

Each ml contains:-Ondansetron Hydrochloride USP Equivalent to Ondansetron…2mgWater for Injection BP……..q.s.

Anti emetic for chemotherapy induced emesis.

Manufacturer’s Specifications

36 months

Diary No. 136/ R&I Dated 15-06-2011 Rs.15000 & 350000 dated 15-10-2012 dy No.951.As per PRC.

setron 2mg/ml by M/s Hameln

Local. Zofran by M/s GSK.

valid upto 13-12-2013. GMP compliant as per COPP.GMP valid upto 30-12-2016.

as per Import Policy for Finished Drugs. Firm will provide valid legalized CoPP and Chairman Registration Board will permit further processing of case.

2. M/s. AJ Mirza Pharma (Pvt) Ltd., Karachi. Manufactured byM/s. Cipla Ltd., L-147 to L0147-1, Verna Industrial Estate, Verna Goa, India.

Emeset 4mg Tablets

Each film coated tablets contains:-Ondansetron Hydrochloride USP Equivalent to Ondansetron……4mg



36 months

Form 5A Dy.No 79 15-06-2011Rs.15000/15-10-2012Rs.35000/-

As per PRC

MHRA.Ondansetron 4mg tablet by M/s Accord

Local. Zofran 4mg by M/s GSK.

COPP issued on 12-06-2008 by India. GMP compliant as per COPP.GMP 29-06-2017.

Deferred for the submission of valid legalized COPP, as it was expired at time of submission of registration application.

3. M/s. Merixil PharmaOffice No 28, 2nd Floor, Rose Plaza I-8 Markaz, Islamabad. Manufactured ByM/s.

Capecitabine Labosuan/Mericap500mg Tablet

Each film coated tablet contains:-Capecitabine….500mg

adjuant treatment of patients following

Form 5ADy. No. 261 Dated 27-07-2011 Rs. 15000/-09-12-2014Rs. 85000/- dy No. 225.

MHRA. Capecitabine 500mg f/c by M/s Accord.

Local. Xeloda 500mg by M/s Roche.

COPP issued by Spain dated 12-01-2016.Brand Name for Pakisatn Mericap Tablet.

Approved as per Import Policy for Finished Drugs


Laboratorios Normon, S.A. Ronda De Valdecarrizo, 6, Tres Cantos, 28760, Madrid, Spain.

surgery of stage III colon cancer, meta-static colo-rectal cancer

USP Specifications

As per PRC GMP compliant as per COPP.GMP issued 13-06-2014.

4. M/s. Merixil PharmaOffice No 28, 2nd Floor, Rose Plaza I-8 Markaz, Islamabad.Product License HolderM/s Fair-Med Healthcare GmbH Planckstrasse 13, 22765 Hamburg, Germany.Manufactured byM/s. Eirgen Pharma Ltd. 64/65 Westside Business Park Old Kilmeaden Road, Waterford, Ireland.

Temoeirgen 100mg Capsules

Each capsule contains:-Temozolomide…100mg

For newly diagnosed Glioblastoma multiforme concomitantly with radiotherapy.


24 Months

Form 5A Dy. No. 721 dated 18-08-2011 Rs. 15000/- 08-12-2014 Rs 85,000/- dy No. 226.

As per SRO

MHRA. Temodal 5mg, 20mg, 100mg, 140mg, 180mg & 250mg by M/s Merck

Local. Temoside 20mg, 100mg & 250mg by M/s AJ. Mirza.

COPP issued on 04-02-2015 by HPRA Ireland. GMP compliant as per COPP.GMP issued dated 28-02-2014 by Irish Medicine Board.


5. M/s. Oncogene Pharmaceuticals, Karachi

Product License HolderM/s. Laboratorios Aspen S.A. Remedios

Anaskebir 1mg Coated Tablet

Each film coated tablet contains:-Anastrozole……1mg


Form 5A

Dy No. 1198 dated 28-11-2012 Rs.100,000/-

Rs.3300/Pack

MHRA. Anastrozole 1mg f/c by M/s consilent.

Local. Anastrozole 1mg by M/s Pfizer

COPP issued on 29-08-2012 and valid upto 28-08-2013.GMP compliant as per

Deferred for the submission of following:a. valid legalized COPP, as already it was valid


3439/43, C1407HJC, Buenos Aires, Argentina.Manufactured byM/s Laboratorios Eczane Pharma S.A. Laprida 43 Localidad Avellaneda. Prov. Bs. As Craveri S.A.I.C-Arengreen 830, CABA Blipack S.A-Av. Juan B. Justo 7669, Caba.

(Treatment of harmone recpotor positive advanced breast cancer in post menopausal women)

CoPP.Stability data as per conditions of Zone IV-A not attached.DSL is not attached.Clarification regarding the place of manufacture.

upto 28-08-2013.b. Stability data as per conditions of Zone IV-A.Druds c. Sales License.d. Clarification regarding the manufacturing site as it is different in Form5A and CoPP.

6. M/s. Oncogene Pharmaceuticals, Karachi

Product License HolderM/s. Laboratorios Aspen S.A. Remedios 3439/43, C1407HJC, Buenos Aires, Argentina.Manufactured byM/s Laboratorios Eczane Pharma S.A. Laprida 43 Localidad Avellaneda. Prov. Bs. As Craveri S.A.I.C-

Kebirzol 2.5mg Coated Tablets

Each tablet contains:-Letrozole……2.5mg

(Adjuant treatment of post-menopausal women with harmone recpotor positive invasive early breast cancer).

USP Specifications

Form 5A

Dy No. 1197 dated 28-11-2012 Rs.100,000/-

Rs.5000/pack

MHRA. Femra 2.5mg f/c tablet by M/s Novartis.

Local. Femra 2.5mg by M/s Novartis.

The product is not actually in the market of country of origin as mentioned in COPP.DSL is not attached.GMP certificate is not attached.Complete description of the

Deferred for the submission / clarification of following a. The product is not actually in the market of country of origin as mentioned in COPP.b. Drug Sales License.c. Complete description of the


Arengreen 830, CABA Blipack S.A-Av. Juan B. Justo N 7.669, CABA.

tablet is not provided as film coated.Clarification is required for manufacturer and market authorization holder.Stability data as per conditions of Zone IV-A not attached.Clarification regarding the place of manufacture.

tablet.d. Clarification is required for manufacturer and market authorization holder.e. Stability data as per conditions of Zone IV-A.f. Clarification regarding the manufacturing site as it is different in Form5A and CoPP

7. M/s. Amgomed, Office # 5, 1st

Floor Rose 1, Plaza I-8 Markaz, Islamabad.

Manufactured byM/s. West Pharma, Producoes de Especialiaes Farmaceuticas, SA Rua Joao de Deus, n. 11, Amadora, 2700-

Farmatide 50mg Tablets

Each film coated tablets contains:-Bicalutamide ………….50mg

Adjuant to radial prostectomy or radio-therapy in patients with locally advanced prostate cancer

USP Specifications

03 years

Form 5A

Dy No.510 dated 09-06-2014Rs.100,000/-

As per SRO

MHRA. Bicalutamide 50mg f/c by M/s Sun pharma.

Local. Calutide 50mg by M/s AJ. Mirza.

Photocopy of legalized COPP issued dated 30-01-2014 (Photocopy)GMP compliant as per COPP. (Photocopy)

Deferred for the submission of valid legalized COPP.


486, Portugal.

8. M/s. Lundbeck Pakistan (Pvt) Ltd., 40 T/4, Blessing Street, Block 6, P.E.C.H.S, Karacki. Market Authorization Holder.M/s. H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark.Manufacturer also responsible for batch release QC, Primary & Secondary Packaging.M/s. H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark.Site Responsible for Quality ControlM/s Eurofins Pharma A/S, Ornebjergvej 1, 2600 Glostrup, Denmark.Site for Primary & Secondary Packaging.M/s Elaiapharm, 2881, route des Cretes, Z.I. Les Bouillides, Sophia Antipolis, 06560, France.

Brintellix 10mg Tablets

Each film coated tablet contains:-Vortioxetine hydrobromide …10mg equivalent to 10mg Vortioxetine

(Receptor Antagonist). New Molecule


30 months

Form 5-A

Dy No.56930-06-2014Rs.50,000/-

Rs.265/tablet

MHRA. Brintellix 5, 10 & 20mg f/c tablet by M/s Lundbeck.

Orignal legalized COPP issued by EMA on dated 04-02-2014GMP compliant as per CoPP.


9. M/s. Lundbeck Brintellix 20mg Tablets Form 5-A MHRA. Orignal Approved


Pakistan (Pvt) Ltd., 40 T/4, Blessing Street, Block 6, P.E.C.H.S, Karacki.

Authorization Holder.M/s. H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark.Manufacturer also responsible for batch release QC, Primary & Secondary Packaging.M/s. H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark.Site Responsible for Quality ControlM/s Eurofins Pharma A/S, Ornebjergvej 1, 2600 Glostrup, Denmark.Site for Primary & Secondary Packaging.M/s Elaiapharm, 2881, route des Cretes, Z.I. Les Bouillides, Sophia Antipolis, 06560, France.

Each film coated tablet contains:-Vortioxetine hydrobromide …20mg equivalent to 20mg Vortioxetine

(Receptor Antagonist). New Molecule


30 months

Dy No.57030-06-2014Rs.50,000/-

Rs.398/tablet.

Brintellix 5, 10 & 20mg f/c tablet by M/s Lundbeck.

legalized COPP issued by EMA on dated 03-02-2014GMP compliant as per CoPP.

as per Import Policy for Finished Drugs

10. M/s. CCL Pharmaceuticals (Pvt) Ltd., 65-

Praxed Injection 100mg

Each vial contains:-

Form 5A

Dy No.Nil

MHRA. Alimta 100mg & 500mg

Dossier is a photocop

Deferred for the submissio


Industrial Estate, Kot Lakhpat, Lahore

M/s. Glenmark Generics S.A. Calle 9 Ing. Meyer Oks No 593 Pilar (B1629 MAX), Buenos Aires, Argentina.

Pemetrexed (as disodium)………..100mg

(Malignant pleural mesothelioma non-small cell lung cancer)


03 years

dated 30-06-2014 Rs.50,000/-

As per Brand leader

powder for conc. For infusion by M/s Eli Lilly.

Local. Alimta 100mg & 500mg by M/s Eli Lilly.

y.Fee Rs.50,000 is a photocopy.Differential fee not provided.Photocopy of COPP issued dated 06-12-2013. (valid for 12 months)Brand Name Proxed. GMP compliant as per CoPP.Stability data for one batch is attached.

n of following.a. Verification of Fee Rs.50,000 as it is a photocopy.b. Differential fee as molecule is me too.c. Valid legalized COPP d. Stability data as per conditions of Zone IV A.

11. M/s. CCL Pharmaceuticals (Pvt) Ltd., 65-Industrial Estate, Kot Lakhpat, Lahore

M/s. Glenmark Generics S.A. Calle 9 Ing. Meyer Oks No 593 Pilar (B1629 MAX), Buenos Aires, Argentina.

Praxed Injection 500mg

Each vial contains:-Pemetrexed (as disodium)………..500mg



Form 5A

Dy No.Nil dated 30-06-2014 Rs.50,000/-

As per Brand leader

MHRA. Alimta 100mg & 500mg powder for conc. For infusion by M/s Eli Lilly.


Dossier is a photocopy.Fee Rs.50,000 is a photocopy.Differential fee not provided.Photocopy of

Deferred for the submission of following.a.Verification of Fee Rs.50,000 as it is a photocopy.b.Differential fee as molecule is me too.


03 years COPP issued dated 06-12-2013. (valid for 12 months)Brand Name Proxed.

GMP compliant as per CoPP.Stability data for one batch is attached.

c. Valid legalized COPP d. Stability data as per conditions of Zone IV A.

12. M/s. Revive Health Care,Office 503, 5th

Floor, 6 Main Gulberg, Jail Road, Lahore.

Manufactured ByM/s. United Biotech (P) Ltd., Village Bagbania, Baddi-Nalagarh Road, District-Solan (H.P) 174101, India.

Pemex Injection 500mg

Each vial contains:-Pemetrexed (As Pemetrexed Disodium)…….500mgExcipients…….q.s



24 months

Form 5A

Dy no 24 dated 04-07-2014 Rs.100,000/-

As per SRO.



COPP valid upto 10-05-2017. GMP compliant as per COPP.

Free sales certificate issued dated 26-02-2016.

GMP valid upto 17-09-2017.




Cagin 50mg Injection

Each vial contains:-Caspofungin Acetate eq. to Caspofungin…….50mg

Form 5A

Dy No.26 dated 04-07-2014 Rs.50,000/-

MHRA. Cancidas 50 powder for conc. For infusion by M/s MSD.

Free sales certificate issued dated 26-02-2016.

Deferred as Anti-fungal drugs are not importable


M/s. United Biotech (P) Ltd., Village Bagbania, Baddi-Nalagarh Road, District-Solan (H.P) 174101, India.

(Antifungal/Supportive cancer therapy) New Molecule

Manufacturer’s Specifications.

24 months

As per PRCCOPP valid upto 10-5-2017.GMP valid upto 17-09-2017.

from India as per Import Policy Order, 2016.



Manufactured byM/s. United Biotech (P) Ltd., Village Bagbania, Baddi-Nalagarh Road, District-Solan (H.P) 174101, India.

Doxulip 20mg Injection

Each ml contains:-Doxorubicin Hydrochloride USP..2mg(As pegylated Liposomal)

Alone for meta-static breast cancer, advanced ovarian cancer. In combination with Bortezomide for treatment of progressive multiple myeloma.


24 months

Form 5A

Dy. No. 27 dated 04-07-2014 Rs.100,000/-

As per PRC.

MHRA. Caelyx 2mg/ml (10ml) by M/s Janssen.

Local. Doxopeg 20mg/10ml by M/s Ferozsons.

COPP valid upto10-05-2017.

GMP compliant as per COPP.Free sales certificate issued dated 26-02-2016.





Manufactured byM/s. United Biotech (P) Ltd., Village Bagbania, Baddi-Nalagarh

Temotec 100mg Capsules

Each capsules contains:-Temozolomide USP…………..100mg

For newly diagnosed Glioblastoma multiforme concomitantly with radiotherapy

Manufacturer’s

Form 5A

Dy. No 28 dated 04-07-2014 Rs.100,000/-

As per SRO



COPP valid upto 10-05-2017.

GMP compliant as per COPP.

Free sales issued dated 26-



Road, District-Solan (H.P) 174101, India.

Specifications

24 months

12-2015.




M/s. United Biotech (P) Ltd., Village Bagbania, Baddi-Nalagarh Road, District-Solan (H.P) 174101, India.

Ambilip 50mg Injection

Each vial contains:-Liposomal Amphotericin B USP………50mg

Antifungal


24 months

Form 5A

Dy No.29 dated 04-07-2014Rs.100,000/-

As per SRO.

MHRA. Ambisome 50mg Powder for Infusion by M/s Gilead.

Local. Anfogen 50mg, Ferozsons



Free sales issued dated 26-02-2016.


Defered as the product does not fall in the priority list. Moreover Anti-fungal drugs are not importable from India as per Import Policy Order, 2016




Oncotar 100mg Injection

Each ml contains:-Cytarabine injection BP………100mgWater for injection s IP………….q.s.

Acute myeloid leukaemia and for other acute leukaemias for children and adults

USP Specifications

24 months

Form 5A

Dy. No 30 dated 04-07-2014 Rs.100,000/-

As per PRC

MHRA. Cytarabine 100mg/ml by M/s Pfizer.

Local. Cytarine 100mg, 500mg & 1gm by M/s Atco.



FSC issued dated 26-02-2016.







Unicristin 1mg injection

Each ml contains:-Vincristine Sulphate USP…..1mg

Indicated for leukemias, malignant lymphomas, multiple myeloma, solid tumors

USP Specifications

24 months

Form 5A

Dy. No 25 dated 04-07-2014Rs.100,000/-

As per SRO

MHRA. Vincristine Sulphate 1mg/ml by M/s Hospira.

Local. Vinfate by M/s Aster.

COPP valid upto 10-05-2017. GMP compliant as per COPP.FSC issued dated 26-02-2016.GMP valid upto 17-09-2017


19. M/s. Novartis Pharma (Pakistan) Limited, 15 West Wharf, Karachi.

Manufactured by.M/s. Novartis Pharma Stein AG, Stein, Switzerland.

Afinitor 2mg Dispersible Tablets

Each dispersible tablet contains:-Everolimus………………2mg

(for harmone receptor positive advaced breast cancer, neuro-endocrine tumors of pancreatic origion, gastro-intestinal or lung origin renal cell carcinoma)

30 months

Form 5A

Dy No. Nil dated 16-07-2014Rs.50,000/-

Rs. 126,000/30’s.

FDA. Afinitor 2mg, 3mg & 5mg Disperz Tablets by M/s Novartis.

Dossier is photocopy fee Rs. 50,000 is photocopy.Photocopy of COPP provided.GMP attached.

Deferred for the verification of fee and submission of valid legalized CoPP.


Manufactured by.M/s. Novartis

Afinitor 3mg Dispersible TabletsEach dispersible tablet contains:-Everolimus………………3mg

(for harmone receptor positive advaced breast cancer, neuro-endocrine

Form 5A

Dy No. 88 dated 16-07-2014 Rs.50,000/-

Rs.189000/30’s


Dossier is photocopy fee Rs. 50,000 is photocopy.Photocopy of



Pharma Stein AG, Stein, Switzerland.

tumors of pancreatic origion, gastro-intestinal or lung origin renal cell carcinoma)


30 months

COPP provided.GMP attached.


Manufactured by.M/s. Novartis Pharma Stein AG, Stein, Switzerland.

Afinitor 5mg Dispersible Tablets

Each dispersible tablet contains:-Everolimus………………5mg

(for harmone receptor positive advaced breast cancer, neuro-endocrine tumors of pancreatic origion, gastro-intestinal or lung origin renal cell carcinoma)


30 months

Form 5A

Dy No. 87 dated 16-07-2014 Rs.50,000/-

Rs.315000/30’s


Dossier is photocopy fee Rs. 50,000 is photocopy.Photocopy of COPP provided.GMP attached.


22. M/s. Macter International Limited, F-216, SITE, Karachi. Manufactured byM/s. Atlanta Biological (Pvt) Ltd.,Village-Kotla, Barotiwala, Baddi, Distt. Solan, (H.P) India.

Gefwin 250mg Tablets

Each Film Coated Tablets contains:-Gefitinib………..250mgExcipients………qs

(Advanced or meta-static non small cell lung cancer)

Form 5A Dy. No 3121 Dated 07-08-2014 Rs.50,000/-

Rs.As per PRC

MHRA. Iressa 250mg f/c tablet by M/s AstraZeneca.

COPP not provided

GMP not attached. Stability data as per conditions of Zone IV-A not attached.Finished product specifications are

Deferred for the submission of following:a. valid legalized COPP b. Stability data as per conditions of Zone IV-A.c. Finished product specifications.


not provided.Sole Agency agreement is not attached

d. Sole Agency agreement.

23. M/s. Macter International Limited,F-216, SITE, Karachi. /Marketing Authorization:M/s. Atlanta Biological (Pvt) Ltd.,Poddar Court 9th Floor, Gate No.1, 18 Rabindra Sarani, Kolkata-700001, India.Manufacturing facility: M/s. Ladley Formulations Village Kotla, Barotiwala, Distt. Solan (H.P), India.

Cytonib Tablet 100mg

Each tablets contains:-Imatinib Mesylate………100mg

(Philadelphia chromosome positive chronic myeloid leukemia)

Manufacturer’s Specifications02 years

Form 5A Dy. No 872 Dated 29-08-2014Rs.50,000/-

MHRA. Glivec 100mg & 400mg f/c by M/s Novartis.

Local. Glivec 100mg & 400mg by M/s Novartis Pharma.

COPP valid upto 22-08-2014 but the addresses of Market authorization holder and manufacturer are not as per COPP.

GMP not provided.Stability data as per Zone IV-A not provided.

Deferred for the clarification of following:a. COPP as the addresses of Market authorization holder and manufacturer are not as per COPP.

b. Stability data as per Zone IV-A.

24. M/s. Macter International Limited,F-216, SITE, Karachi. /Marketing Authorization:M/s. Atlanta Biological (Pvt) Ltd., Poddar Court 9th Floor, Gate No.1, 18 Rabindra Sarani,

Bortemore 3.5mg Injection Each vial contains:-Bortezomib…………3.5mg

(Lumphocutic leukemia, indolent non-Hodgkin’s lymphoma, multiple myeloma).

Form 5ADy. No 873 dated 29-08-2014Rs.50,000/-

As per PRC.

MHRA. Velcade 3.5mg (as mannitol boronic ester) Powder for solution for injection.

COPP valid up to 22-08-2014 but the addresses of Market authorization holder and manufact

Deferred for the submission / clarification of the followinga. addresses of market authorization holder and


Kolkata-700001, India.Manufacturing facility: M/s. Ladley Formulations Village Kotla, Barotiwala, Distt. Solan (H.P), India.

02 years urer are not as per COPP.Stability data not attached.Finished product specifications are not provided.Internationaly the product is present as mannitol boronic ester.Clarification whether the product is in liquid form or powder form.

manufacturer are not as per COPP.b.Stability data as per conditions of Zone IV A.c.Finished product specifications.d. Internationaly the product is present as mannitol boronic ester.e.whether the product is in liquid form or powder form.

25. M/s. GlaxoSmithKline Pakistan Limited, 35-Dockyard Road, West Wharf, Karachi-74000.

Market Authorization HolderM/s.

Requip PD 2mg Tablets

Each prolonged release tablets contains:-Ropinirole hydrochloride equivalent to 2mg ropinirole free base

(Non-ergoline D2/D3 dopamine agonist)

Form 5A

Dy No. 6581 R&I dated 8-09-2014 Rs.50,000/-

Will be submitted later

MHRA.. Aimpart Excel 2mg, 4mg and 8mg prolonged release tablets by M/s Zantiva

COPP issued dated10-07-2014 vide No. 014/1680 by Spain.GMP compliant as per COPP.



Glaxosmithkline, S.A. Severo Ochoa, 2 28760-Tres Cantos (Madrid) Spain.Manufactured byM/s Glaxo Wellcome, S.A. Avda. De Extremadura, n 3 09400-Aranda De Duero (Burgos) Spain.

New formuation

18 months


Market Authorization HolderM/s. Glaxosmithkline, S.A. Severo Ochoa, 2 28760-Tres Cantos (Madrid) Spain.Manufactured byM/s Glaxo Wellcome, S.A. Avda. De Extremadura, n 3 09400-Aranda De Duero (Burgos) Spain.


Each prolonged release tablets contains:-Ropinirole hydrochloride equivalent to 4mg ropinirole free base

(Non-ergoline D2/D3 dopamine agonist) New formuation

(24 months)

Form 5A

Dy No.656 R&I dated 08-09-2014 Rs.50,000/-


MHRA.. Aimpart Excel 2mg, 4mg and 8mg prolonged release tablets by M/s Zantiva

COPP issued dated10-07-2014 vide No. 014/1678 by Spain.GMP compliant as per COPP.


27. M/s. GlaxoSmithKline Pakistan Limited, 35-


Each prolonged release

08-09-2014Rs.50,000/-

MHRAAimpart Excel 2mg, 4mg and 8mg

COPP issued dated10-07-2014

Approved as per Import Policy for


Dockyard Road, West Wharf, Karachi-74000.

Market Authorization HolderM/s. Glaxosmithkline, S.A. Severo Ochoa, 2 28760-Tres Cantos (Madrid) Spain.Manufactured byM/s Glaxo Wellcome, S.A. Avda. De Extremadura, n 3 09400-Aranda De Duero (Burgos) Spain.

tablets contains:-Ropinirole hydrochloride equivalent to 8mg ropinirole free base

(Non-ergoline D2/D3 dopamine agonist) New formulation

(24 months)

prolonged release tablets by M/s Zantiva

vide No. 014/1679 by Spain.GMP compliant as per COPP.

Finished Drugs

28. M/s. Bayer Pakistan (Private) Limited, C-21, S.I.T.E., Karachi

Product license holder: M/s. Jenapharm GmbH & Co. KG, Otto-Schott-Strasse 15 D-07745 Jena Germany Bulk Manufacturer, Packaging and final release:M/s. Bayer Weimar GmbH & Co. KG DÖbereinerstrasse 20 99427

Visanne (Dienogest) 2mg Tablets

Each tablet contains:-Dienogest………….2mg

(Steroid Hormones)New Molecule


36 months

Form 5A

Dated 10-09-2014 vide diary No. 667Rs.50,000/-

Not mentioned

Germany. Visanne (Dienogest) 2mg Tablets

COPP issued dated 11-06-2014.GMP issued dated 26-04-2013. Approval status require to be provided.Now the firm has requested for the finished import from Germany.



Weimar, Germany.

29. M/s. PharmEvo (Pvt) Ltd.,Plot No. A-29, North West Industrial Zone, Port Qasim, Karachi

Manufactured By.M/s. Hetero Labs Limited Unit – VI Sy No. 410 & 411, APIIC Formulation SEZ, Polepally Village, Jadcherla Mandal, Mahaboob Nagar (Dist) 509301, Andhra Pradesh, India.

Bicatero 50mg Tablets

Each film coated tablets contains:-Bicalutamide USP……….50mg

(Adjuant to radial prostectomy or radio-therapy in patients with locally advanced prostate cancer)

USP Specifications

02 years

Form 5A

Dy. No 673 Dated 11-09-2014 Rs.100,000/-

As per PRC

MHRA. Bicalutamide 50mg f/c by M/s Sun pharma.

Local. Calutide 50mg by M/s AJ. Mirza.

COPP valid upto 19-09-2014. GMP compliant as per COPP.

Photocopy of GMP valid upto 19-09-2014.

Stability data is not as per conditions of Zone IV-A.

Deferred for the submission of Stability data as per conditions of Zone IV-A & valid legalized COPP.

30. M/s. PharmEvo (Pvt) Ltd.,Plot No. A-29, North West Industrial Zone, Port Qasim, Karachi Manufactured By.M/s. Hetero Labs Limited Unit – VI Sy No. 410 & 411, APIIC Formulation SEZ, Polepally Village,

Bentero 100mg Injection

Each vial contains:-Bendamustin Hydrochloride…………100mgWater for injections……….Ph.Eur….q.s.

(Lumphocutic leukemia, indolent non-Hodgkin’s lymphoma, multiple myeloma)

Manufacturer’s

Form 5 A

Dy. No 676 dated 11-09-2014 Rs.100,000/-

As per SRO

FDA. Bendamustine powder for infusion by M/s Hospira.


Photocopy of GMP 19-09-2014.

Stability data is not as per conditions of Zone IV-A.

Deferred for the submission of a.Stability data as per conditions of Zone IV-A.b.valid legalized COPP.c.Separate application for the registration applicatio


Jadcherla Mandal, Mahaboob Nagar (Dist) 509301, Andhra Pradesh, India.

Specifications

02 years

Firm has not applied for separate registration of water for injection.

n for WFI.



Bortero 3.5mg Injection

Each vial contains:-Bortezomib…….3.5mgWater for Injection Ph.Eur….q.s



02 years

Form 5A

Dy. No 673 dated 11-09-2014 Rs.100,000/

As per SRO.

MHRA. Velcade 3.5mg (as mannitol boronic ester) Powder for solution for injection.

COPP valid upto 30-12-2015


Stability data not provided.

Internationaly the product is present as mannitol boronic ester.Firm has not applied for separate registration of water for injection.

Deferred for the submission of a.Stability data as per conditions of Zone IV-A.b.valid legalized COPP.c.Separate application for the registration application for WFI.

32. M/s. PharmEvo (Pvt) Ltd.,

Capetero 500mg Tablets Form 5A MHRA. Capecitabine

COPP valid

Deferred for the


Plot No. A-29, North West Industrial Zone, Port Qasim, Karachi.


Each film coated tablets contains:-Capecitabine USP………500mg(adjuant treatment of patients following surgery of stage III colon cancer, meta-static colo-rectal cancer)

USP Specifications

02 years

Dy. No 678 dated 11-09-2014 Rs.100,000/-

As per SRO.

500mg f/c by M/s Accord.


upto 19-09-2014.

Photocopy GMP valid upto 19-09-2014.

Stability is not as per conditions of Zone IV A.

submission of a.Stability data as per conditions of Zone IV-A.b.valid legalized COPP.c.Separate application for the registration application for WFI.


Manufactured By.M/s. Hetero Labs Limited Unit – VI Sy No. 410 & 411, APIIC Formulation SEZ, Polepally Village, Jadcherla Mandal, Mahaboob Nagar (Dist)

Capetero 150mg Tablets

Each film coated tablets contains:-Capecitabine USP………150mg

(adjuant treatment of patients following surgery of stage III colon cancer, meta-static colo-rectal cancer)

USP Specifications

02 years

Form 5A

dy. NO 675 dated 11-09-2014 Rs.100,000/-

As per SRO

MHRA. Capecitabine Accord 150mg f/c by M/s Accord.


Photocopy GMP valid upto 19-09-2014.


Deferred for the submission of Stability data as per conditions of Zone IV-A & valid legalized COPP.


509301, Andhra Pradesh, India.

34. M/s GlaxoSmithKline Pakistan Limited 35-Dockyard Road, West Wharf, Karachi.

M/s Glaxo Operations UK Limited, Ware UK

Anoro ElliptaDry Powder InhalerEach pre-dispensed dose contains.Umeclidinium…….62.5mcgVilanterol (as trifenatate)…25mcg(Long acting muscarinic antagonist (LAMA), and a long-acting beta-2 agonist (LABA)New Molecule

Form-5A Dy. No: 693 dated 18-09-201450,000/- dated 18-09-2014

MRP will be submitted later

MHRA. Ano Ellipta by M/s GSK

Already approved in 254th

meeting but later on deleted in 256th

meeting as the decision on new molecules was not clear. COPP issued on 06-08-2014.



Product License Holder.M/s. Novartis Pharma Schweiz AG, 6343, Risch, Switzerland. Manufactured ByM/s Novartis Pharma Stein AG Schaffhauserstrasse 4332 Stein, Switzerland

Sandostatin 0.2mg/ml Multi-dose Vial

Each 5ml vial contains:-Octreotide…………….1mg

Acromegaly/Carcinoid Tumors / Vasoactive Intestinal tumors


48 months

Form 5A Dy. No 701 dated 22-09-2014 Rs.50,000/-

Rs.9400/5ml vial

MHRA. Sandostatin 1000mcg/5ml by M/s Novartis.

COPP issued by Swiss medica Switzerland on 21-03-2014. GMP 07-04-2014.


36. M/s. Novartis Pharma (Pakistan)

Sandostatin 0.5mg/ml Ampoule

Form 5A Dy. NO 700 Dated

MHRA. Sandostatin 500mcg/1ml

COPP issued on 21-03-

Approved as per Import


Limited, 15 West Wharf, Karachi.

Product License Holder.M/s. Novartis Pharma Schweiz AG, 6343, Risch , Switzerland. Manufactured ByM/s Novartis Pharma Stein AG Schaffhauserstrasse 4332 Stein, Switzerland

Each 1ml ampoule contains:-Octreotide…………….0.5mg

Acromegaly/Carcinoid Tumors / Vasoactive Intestinal tumors

Manufacturer’s Specifications36 months

22-09-2014 Rs.50,000/-

Rs.23,000/5 ampoules.

by M/s Novartis.

2014 by Switzerland. GMP 07-04-2014

Policy for Finished Drugs

37. M/s. GlaxoSmithKline Pakistan Limited, 35-Dockyard Road, West Wharf, Karachi.

Market Authorization HolderM/s ViiV Healthcare UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Manufactured by M/s. M/s GlaxoSmithKline Pharmaceuticals SA, ul. Grunwaldzka 189, 60-322

Kivexa TabletsEach film coated tablets contains:-Abacavir 600mg (as abacavir sulfate) andLamivudine………..300mg

(HIV Indicated for the management of HIV infection) New formulation & Anti HIV

36 months

Form 5A

Dy No. 729 R&I dated 30-09-2014Rs.50,000/-

Will be submitted later.

MHRA. Kivexa by M/s ViiV

COPP issued dated 16-05-2014 vide no. 10/14/76509 by EMA.GMP compliant as per COPP.



Poznan, Poland.Site Responsible for Primary & Secondary PackagingM/s Glaxo Wellcome S.A., Avenida Extremadura 3, Aranda de Duero, Burgos, 09400, Spain.



Manufactured by M/s. Glaxo Operations UK Ltd, Priory Street, Ware, Hertfordshire SG12 ODJ, United Kingdom.Site Responsible for Primary & Secondary PackagingM/s Glaxo

Tivicay Tablets

Each film coated tablet contains:-Dolutegravir (as Dolutegravir Sodium)……50mg

(HIV. Indicated for the management of HIV infection) New Molecule

24 months

Form 5-ADy.No.45 R&I Dated 16-10-2014 Rs.50,000/-

Price will be provided later

MHRA. Tivicay by M/s ViiV

Legalized COPP was issued by EMA dated.19.08-2014



Wellcome S.A., Avenida Extremadura 3, Aranda de Duero, Burgos, 09400, Spain.

39. M/s. RG Pharmaceutica (Pvt) Ltd., Progressive Square, Block 6, Shahra-e-Faisal, Karachi-75400./M/s. Shin Poong Pharmaceutical Co. Ltd., 70, Sandan-ro 19beon-gil, Danwon-gu Ansan-si Gyeonggido, Korea.

Pyramax 180mg/60mgEach film coated tablets contains:-Artesunate…………60mgPyronaridine tetraphosphate………180mg(Pyronaridine in combination with artesunate, an artemisinin derivative). New Molecule / formualtion02 years

Form 5A

Dy No. 84 dated 10-11-2014 Rs.50,000/-

Rs. 142/tablet

WHO approved formulation for treatment of malaria

Free sales certificate issued dated 17-08-2011 vide No. 2014-A1-0403. GMP certificate issued dated 17-07-2013 vide No. 2013-D1-2253.


40. M/s. Premier Agencies,60-Muslimabad, Jamshed Quarters M.A. Jinnah Road Extension, Karachi.-74800

Manufactured byM/s. Hetero Labs Limited ,Unit-VI, Sy. No.410 & 411, APIIC Formulation SEZ, Polepally Village, Jadcherla Mandal, Mahaboob Nagar (Dist)

Gemtero 1.0g Injection

Each vial contains:-Gemcitabine Hydrochloride equivalent to Gemcitabine 1.0g for injection (Advanced or met-static bladder cancer in combination with cisplatin, locally or meta-static adenocarcinoma of pancreas)

USP Specifications

02 years

Form 5A

DY. No 71 dated 13-11-2014Rs.100,000/

As per SRO

MHRA. Gemcitabine 1g Powder for injection by M/s Ranbaxy

COPP/Free sales certificate not attached.GMP certificate is not attached.Stability data is not as per conditions of Zone IV-A.

Deferred for the submission of valid legalized COPP and Stability data as per conditions of Zone IV-A.



41. M/s. Premier Agencies,60-Muslimabad, Jamshed Quarters M.A. Jinnah Road Extension, Karachi

Manufactured byM/s. Hetero Labs Limited ,Unit-VI, Sy. No.410 & 411, APIIC Formulation SEZ, Polepally Village, Jadcherla Mandal, Mahaboob Nagar (Dist) 509301, Andhra Pradesh, India.

Gemtero 200mg Injection Each vial contains:-Gemcitabine Hydrochloride equivalent to Gemcitabine 200mg for injection

(Advanced or met-static bladder cancer in combination with cisplatin, locally or meta-static adenocarcinoma of pancreas)

USP Specifications

02 years

Form 5A

Dated 13-11-2014 vide diary No. 73Rs.100,000/-

As per SRO.

MHRA. Gemcitabine 200mg Powder for injection by M/s Hospira

COPP/Free sales certificate not attached.GMP certificate is not attached.Stability data is not as per conditions of Zone IV-A.



Manufactured byM/s. Hetero Labs Limited ,Unit-VI, Sy. No.410 & 411, APIIC Formulation SEZ, Polepally Village,

Paclitero 30mg/5ml Injection

Each vial contains:-Paclitaxel USP………..30mg/5ml

(Monotherapy for meta-static breast cancer. In combination with Gemcitabin for meta-static adenocarcinoma of pancreas)

USP Specifications

02 years

Form 5A

Dy. No 74 Dated 13-11-2014 Rs.100,000/

As per SRO

MHRA. Paclitaxel 6mg/ml Conc. for solution for infusion by M/s Medac (5ml, 16.7ml, 50ml & 100ml).

Local. Panataxel 100mg, 150mg, 300mg & 30mg by M/s Ferozsons.


Photocopy of GMP upto 19-09-2014.

Stability data not as per conditions of Zone IV A.



Jadcherla Mandal, Mahaboob Nagar (Dist) 509301, Andhra Pradesh, India.


M/s. Hetero Labs Limited ,Unit-VI, Sy. No.410 & 411, APIIC Formulation SEZ, Polepally Village, Jadcherla Mandal, Mahaboob Nagar (Dist) 509301, Andhra Pradesh, India.

Paclitero 100mg/16.7ml Injection

Each vial contains:-Paclitaxel USP………..100mg/16.7ml


USP Specifications

02 years

Form 5A

Dy. No 72 dated 13-11-2014Rs.100,000/

As per SRO





Stability data not as per conditions of Zone IV A.


44. M/s. Premier Agencies,60-Muslimabad, Jamshed Quarters M.A. Jinnah Road Extension, Karachi

M/s. Hetero Labs Limited ,Unit-VI, Sy. No.410 & 411, APIIC Formulation

Paclitero 300mg Injection

Each vial contains:-Paclitaxel USP………..300mg/50ml


Form 5A

Dy. No 75 dated 13-11-2014Rs.100,000/-

As per SRO


Local. Panataxel 100mg, 150mg, 300mg & 30mg by


Photocopy of GMP valid upto 19-09-2014.Stability data is not as per



SEZ, Polepally Village, Jadcherla Mandal, Mahaboob Nagar (Dist) 509301, Andhra Pradesh, India.

USP Specifications

02 years

M/s Ferozsons.

conditions of Zone IV A.


Manufactured by :-M/s. GlaxoSmithKline Manufacturing S.p.A., Strada Provinciale Asolana, 90, 43056 San Polo di Torrile, Parma, Italy.Primary & Secondary Packaging Site:-M/s. Glaxo Wellcome S.A. Avenida Extremadura, 3, 09400 Aranda de Duero, Burgos, Spain.Market Authorization HolderGlaxo Group Ltd, 980 Great West Road, Brentford, Middlesex TW8

Mekinist 0.5mg Tablets

Each film coated tablets contains:-Trametinib dimethyl/ sulfoxide equivalent to 0.5mg trametinib

Mono therapy or in combination with Debrafenib for patients with un-resectable or met-static melanoma

New molecule.


02 years

Form 5A

03-12-2014 vide diary No.188Rs.50,000/-

As per PRC

MHRA. Mekinist f/c tablet 0.5mg & 2mg by M/s Novartis.

The firm has provided 2 COPPs.The first COPP issued dated 19-09-2014 by EMA says that“The product is not actualy in the market of exporting country”GMP compliant as per COPP.The 2nd

COPP issued dated 21-09-2015 says that the product is on free sale in the



9GS, United Kingdom.

exporting country.


Manufactured by :-M/s. GlaxoSmithKline Manufacturing S.p.A., Strada Provinciale Asolana, 90, 43056 San Polo di Torrile, Parma, Italy.Primary & Secondary Packaging Site:-M/s. Glaxo Wellcome S.A. Avenida Extremadura, 3, 09400 Aranda de Duero, Burgos, Spain.Market Authorization HolderGlaxo Group Ltd, 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom.

Mekinist 2mg Tablets

Each film coated tablets contains:-Trametinib dimethyl/ sulfoxide equivalent to 2mg trametinib

Mono therapy or in combination with Debrafenib for patients with un-resectable or met-static melanoma

New molecule.


02 years

Form 5A

Dy. No 187 Dated 02-12-2014 Rs.50,000/-

As per PRC

MHRA. Mekinist f/c tablet 0.5mg & 2mg by M/s Novartis.

The firm has provided 2 COPPs.The first COPP issued dated 19-09-2014 by EMA says that“The product is not actualy in the market of exporting country”GMP compliant as per COPP.The 2nd

COPP issued dated 21-09-2015 says that the product is on free sale in the exporting country.



47. M/s. Care Takers the Healthcare Company,131-B, M.A. Johar Town, Lahore.

M/s. Eskay Speciality Chemicals,Plot No. 207-B & 208 Surat Special Economic Zone, Road No.-4, G.I.D.C., At & Post Sachin, Surat, India.

Microbar HD Powder for Suspension Each 100gm contains:-Barium Sulpahte B.P…………..95gmPalatable Base q.s……………..100gm(X-Ray Contrast Media)03 years

Form 5A

Dy No. 233 dated 15-12-2014 Rs.50,000/-

COPP valid up to 2-5-2015. GMP vslif upto 2-5-2015.

Deferred for the confirmation as X-Ray Contrast Media is not included for priority consideration


Manufactured byM/s. Glaxo Operations UK Limited, Priory Street, Ware Hertfordshire SG12 ODG, United Kingdom.

Market Authorization HolderM/s Glaxo

Incruse Ellipta

Dry Powder InhalerEach pre-dispensed dose contains.Umeclidinium (equivalent to 74.2 mcg of umecidinium bromide)…….62.5mcg

(Long acting muscarinic antagonist (LAMA)

New molecule.

Form-5A

Dy. No: 234 dated 15-12-201450,000/- dated 15-12-2014


Already approved in 254th

meeting but later on deleted by the Board in 256th

meeting as the decision on new molecules is not clear.COPP Issued on 28-10-2014



Group Ltd, 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom.


Manufactured ByM/s. Novartis Pharma Stein AG, Stein, Switzerland.

Zykadia 150mg Hard Gelatin Capsules

Each capsule contains:-Ceritinib…………..150mg

(Anaplastic lymphoma kinase positive advanced non small cell lung cancer)


24 months

Form 5A

Dy. No 243 dated 17-12-2014 Rs.50,000/-

Rs.450,000/50’s capsules.

MHRA. Zykadia 150mg capsule by M/s Novartis.

COPP valid upto 07-07-2016 issued by US FDA.

Deferred for the clarification regarding approval status of product by regulataory authority of Switzerland.


M/s. Novartis Pharma Stein AG, Stein, Switzerland.

Jakavi 10mg Tablet

Each tablet contains:-Ruxolitinib………..10mg

(Myelo fibrosis, polycythemia vera)


24 months

Form 5A

Dy No. Nil dated 24-12-2014 Rs.50,000/-

Rs.418520/56’s tablets

MHRA. Jakavi 5, 10, 15 & 20mg by M/s Novartis.

Dossier is photocopy fee Rs.50,000 is photocopy.Photocopy COPP issued dated07-11-2014.GMP compliant as per COPP.Stability data as per conditions of Zone IV-B attached.

Deferred for the verification of fee, submission valid legalized COPP



M/s. Hetero Labs Limited Unit – VI Sy No. 410 & 411, APIIC Formulation SEZ, Polepally Village, Jadcherla Mandal, Mahaboob Nagar (Dist) 509301, Andhra Pradesh, India.

Temotero 250mg Capsule

Each hard gelatin capsule contains:-Temozolomide…………..250mg

(For newly diagnosed Glioblastoma multiforme concomitantly with radiotherapy)


02 years

Form 5A

DY. 272 dated 24-12-2014 Rs.100,000/

As per SRO






Deferred for the submission of stability data as per conditions of Zone IV A and valid legalized COPP

52. M/s. PharmEvo (Pvt) Ltd.,Plot No. A-29, North West Industrial Zone, Port Qasim, Karachi Manufactured By.M/s. Hetero Labs Limited Unit – VI Sy No. 410 & 411, APIIC Formulation SEZ, Polepally Village, Jadcherla Mandal, Mahaboob Nagar (Dist)

Temotero 5mg Capsule Each hard gelatin capsule contains:-Temozolomide…………..5mg



02 years

Form 5A

Dy. No 273 dated 24-12-2014 Rs.100,000/-

As per SRO










Temotero 20mg Capsule Each hard gelatin capsule contains:-Temozolomide…………..20mg



Form 5A

Dy. NO 270 Dated 24-12-2014 Rs.100,000/-

As per SRO








Manufactured By.M/s. Hetero Labs Limited Unit – VI Sy No. 410 & 411, APIIC Formulation SEZ, Polepally Village, Jadcherla

Temotero 100mg Capsule

Each hard gelatin capsule contains:-Temozolomide…………..100mg



02 years

Form 5A

Dy. No 271 dated 24-12-2014 Rs.100,000/-

As per SRO



Original not provided. Photocy COPP valid upto 30-12-2015. Photocopy of GMP valid upto 19-09-2014.

Stability is not as per condition



Mandal, Mahaboob Nagar (Dist) 509301, Andhra Pradesh, India.

s of Zone IV A.

55. M/s. Gene-Tech Laboratories,Head Office. 246/B, PECHS, Block-6, Karachi.

Manufactured byM/s. Adley Formulations,Vill. Kotla, PO. Borotiwala, Tehsil: Baddi, Distt. Solan, Himachal (H.P) Pradesh, India.

ADPEM 500 Injection

Each vial contains:-Pemetrexed Disodium eq. to Pemetrexed……..…………500mgMannitol USP…………..500mg


24 months

Form 5A

Dy No.255 R&I dated 24-12-2014 Rs.100,000/-

Rs.70,000/vial



COPP valid upto 08-02-2015. No. HFW-H (DRUG) 22/05 (Vol.VI)

GMP certificate valid upto 08-02-2015 No. HFW-H (DRUG) 22/05 (Vol.VI)

Deferred for the submission of followinga. Stability data as per conditions of Zone IV Ab.Sole agency agreementc. Drug Sales License.



CAPAD 500mg Tablets

Each film coated tablet contains:-Capecitabine USP…………..500mg

(adjuant treatment of patients following surgery of stage III colon cancer, meta-static colo-rectal cancer)

24 months

Form 5A

Dy No.256 R&I dated 24-12-2014 Rs.100,000/-

Rs.2083/10’s

MHRA. Capecitabine 500mg f/c by M/s Accord.



GMP certificate valid upto 08-02-2015 No. HFW-H (DRUG) 22/05



(Vol.VI)



BORTIAD 2.0mg Injection

Each vial contains:-Bortezomib………………..2.0mg

(Lymphocytic leukemia, indolent non-Hodgkin’s lymphoma, multiple myeloma)

24 months

Form 5-A

Dy No.257 R&I dated 24-12-2014 Rs.100,000/-

Not mentioned


GMP certificate valid upto 08-02-2015 No. HFW-H (DRUG) 22/05 (Vol.VI)Approval status in reference countries is not provided.Internationaly the product is present as mannitol boronic ester.Clarification whether the product is in liquid form or powder form.

Deferred for the submission of followinga. Approval status by reference regulatory authoritiesb.Stability data as per conditions of Zone IV A.c.Sole agency agreemendd.Drug Sales License.




ADGEF 250mg Tablet

Each film coated tablet contains:-Gefitinib……………250mg

(Advanced or meta-static non small cell lung cancer)

24 months

Form 5-A

Dy No.261 R&I dated 24-12-2014 Rs.100,000/-

Rs.140,000/15’s pack

MHRA. Iressa 250mg f/c tablet by M/s AstraZeneca.

Local.


GMP certificate valid upto 08-02-2015 No. HFW-H (DRUG) 22/05 (Vol.VI)Stability data as per conditions of Zone IV-A is not provided.Sole agency agreement is not provided.



M/s. Adley Formulations,Vill. Kotla, PO.

ADMINE 100mg Tablet

Each film coated tablet contains:-Imatinib MesylateEq. to Imatinib…………100mg

(Philadelphia

Form 5-A

Dy No.259 R&I dated 24-12-2014 Rs.100,000/-

Rs.11083/10’s pack


Local. Glivec 100mg & 400mg by M/s Novartis


Deferred for the submission of followinga. Stability data as per conditions of Zone IV A


Borotiwala, Tehsil: Baddi, Distt. Solan, Himachal (H.P) Pradesh, India.

chromosome positive chronic myeloid leukemia)


24 months

Pharma. GMP certificate valid upto 08-02-2015 No. HFW-H (DRUG) 22/05 (Vol.VI)Stability data as per conditions of Zone IV-A is not provided.Sole agency agreement is not provided.

b.Sole agency agreementc. Drug Sales License.


M/s. Adley Formulations,Vill. Kotla, PO. Borotiwala, Tehsil: Baddi, Distt. Solan, Himachal (H.P) Pradesh, India.

ADMINE 400mg Tablet

Each film coated tablet contains:-Imatinib MesylateEq. to Imatinib…………400mg



24 months

Form 5-A

Dy No.260 R&I dated 24-12-2014 Rs.100,000/-

Rs.46667/10’s pack




GMP certificate valid upto 08-02-2015 No. HFW-H (DRUG) 22/05 (Vol.VI)Stability



data as per conditions of Zone IV-A is not provided.Sole agency agreement is not provided.


M/s. Adley Formulations,Vill. Kotla, PO. Borotiwala, Tehsil: Baddi, Distt. Solan, Himachal (H.P) Pradesh, India.

ERLOTAD 100mg Tablet

Each film coated tablet contains:-Erlotinib HydochlorideEq. to Erlotinib…………….100mg

(Non small cell lung cancer or pancreatic cancer)


24 months

Form 5A

Dy No. 258 R&I dated 24-12-2014 Rs.100,000/-

As per SRO

MHRA. Tarceva 25mg, 100mg & 150mg f/c tablets by M/s Roche.

Local. Tarceva 25mg, 100mg & 150mg f/c tablets by M/s Roche.


GMP certificate valid upto 08-02-2015 No. HFW-H (DRUG) 22/05 (Vol.VI)Stability data as per conditions of Zone IV-A is not provided.Sole agency agreement is not provided.




Manufactured byM/s. Adley Formulations,Vill. Kotla, PO. Borotiwala, Tehsil: Baddi, Distt. Solan, Himachal (H.P) Pradesh, India..

ERLOTAD 150mg Tablet

Each film coated tablet contains:-Erlotinib HydochlorideEq. to Erlotinib…………….150mg

(Non small cell lung cancer or pancreatic cancer)


24 months

Form 5A

Dy No. 254 R&I dated 24-12-2014 Rs.100,000/-

As per SRO

MHRA. Tarceva 25mg, 100mg & 150mg f/c tablets by M/s Roche.

Local. Tarceva 25mg, 100mg & 150mg f/c tablets by M/s Roche.


GMP certificate valid upto 08-02-2015 No. HFW-H (DRUG) 22/05 (Vol.VI)

Stability data as per conditions of Zone IV-A is not provided.Sole agency agreement is not provided.


63. M/s. Group 9 Pakistan, MI, 19-C Rahat Commercial Lane 2, DHA Phase-6, Karachi.

M/s. MDT

Sport Vis TM pre-filled syringe for peri-articular injection Each pre-filled syringe contains:-1.2ml 1% low molecular weight sodium hyaluronatein phosphate buffered

Form 5A

Dy 284 dated 29-12-2014 Rs.50,000/-

Free sales certificate valid upto dated 01-10-2016 by swiss medic

Deferred for the clarification as the complete description as applied on Form 5A


Int,SA,Rue du 31 Decembre, 36 1207 Geneva, Switzerland.Manufacturing site address:Hyaltech Ltd.,Starlaw Business Park EH54 8SF Livingston, United Kingdom.

saline (Peri-articular injection)

36 months

New molecule

but complete description as applied on Form 5A is not mentioned on free sales.Medical Device

is not same as mentioned on free sales certificate. Firm will provide either CoPP or FSC and GMP

64. M/s. Langene Biotech,Head Office. 246/B, PECHS, Block-6, Karach-75400.

M/s. Aburaihan Pharmaceutical Company,No.1, Hojr ebne Oday Ave, Tehranpars Tehran-I.R. Iran.

Letrax 2.5mg Tablet

Each film coated tablet contains:-Letrozole (micronized)…….……..2.5mg

(Adjuant treatment of post-menopausal women with harmone recpotor positive invasive early breast cancer)


03 years

Form 5A

Dy No. 01 dated 01-01-2015 Rs.100,000/-

Rs.6000/30’s Pack.



Non legalized copy of COPP dated 17-09-2014 attached.DSL is not attached.Stability data as per conditions of Zone IV-A is not provided.Sole agency agreement is not provided.

Deferred for the submission of followinga. Valid legalized COPP.b. Drugs Sales License.c. Stability data as per conditions of Zone IV-A d. Sole agency agreement.

65. M/s. Care Takers the Healthcare Company, 131-B, M.A. Johar Town, Lahore.

M/s. Eskay

Microbar CAT 2 Liquid Suspension Each 100ml contains:-Barium Sulpahte B.P…………..7gmPalatable Base q.s……………..100ml(X-Ray Contrast Media)

Form 5A

Dy No. 12 dated 08-01-2015 Rs.50,000/-

COPP valid upto 2-5-2015. GMP valid upto 2-5-2015.

Deferred for the confirmation as X-Ray Contrast Media is not


Speciality Chemicals,Plot No. 207-B & 208 Surat Special Economic Zone, Road No.-4, G.I.D.C., At & Post Sachin, Surat, India.

03 years included for priority consideration

66. M/s. Care Takers the Healthcare Company, 131-B, M.A. Johar Town, Lahore.

M/s. Eskay Speciality Chemicals,Plot No. 207-B & 208 Surat Special Economic Zone, Road No.-4, G.I.D.C., At & Post Sachin, Surat, India.

Microbar for Enema (Disposable Kit) Powder for Rectal Suspension Each 100gm contains:-Barium Sulpahte B.P…………..92gmBase q.s……………………….100gm(X-Ray Contrast Media)03 years

Form 5A

Dy No. 11 dated 08-01-2015 Rs.50,000/-


Deferred for the confirmation as X-Ray Contrast Media is not included for priority consideration


Manufactured By.M/s. Hetero Labs Limited Unit – VI Sy No. 410 & 411, APIIC Formulation SEZ, Polepally

Iritero Injection 40mg/2ml

Each vial contains:-Irinotecan Hydrochloride …….40mg

(Advanced Colorectal cancer)


Form 5A

Dy. No 14 dated 08-01-2015 Rs.100,000/-

As per SRO

MHRA. Campto 20mg/ml, conc. For solution 40mg, 100mg, & 300mg.

COPP/Free sales certificate is not attached.GMP certificate is not attached.Stability data is not as per conditions of Zone IV-A.

Deferred for the submission of following a. Stability data as per conditions of Zone IV-A.b. Valid Legalized CoPP.


Village, Jadcherla Mandal, Mahaboob Nagar (Dist) 509301, Andhra Pradesh, India.



Iritero Injection 100mg/5ml

Each vial contains:-Irinotecan Hydrochloride …….100mg



03 years

Form 5 A

Dy. No 13 dated 08-01-2015 Rs.100,000/-

As per SRO

MHRA. Campto 20mg/ml, conc. For solution 40mg, 100mg, & 300mg.

COPP/Free sales certificate is not attached.GMP certificate is not attached.Stability data is not as per conditions of Zone IV-A.

Deferred for the submission of following a. Stability data as per conditions of Zone IV-A.b. Valid Legalized CoPP.

69. M/s. Biomedics Medical System, F-597, F-Block, Satellite Town, Rawalpindi.

Manufactured byM/s. Ain Medicare SDN.BHD, Jalan 6/44, Kawasan

Ipraneb 500 mcg /2ml Nebuliser Solution

Each 2ml vial contains:-Ipratropium Bromide…………………….500mcg/2ml

(Anticholinergics) New Formulation


Form 5A

Dy No.20 dated 14-01-2015 Rs.50,000/-

Rs.450/Vial 2ml

MHRA. Atrovent 2ml 250mcg/ml by M/s Boehringer.

COPP issued by Malaysia Drug Control Authority on dated 31-10-2014 vide Number 1879/2014.



Perindustrian Pengkalan Chepa 2, 16100 Kota Bharu Kelantan Darul Naim, Malaysia.

02 yearsGMP certificate issued dated 29-10-2014 vide No. 413/14 valid upto 04-01-2017Stability data on the conditions of water loss is attached being semi permeable containers.

70. M/s. Ali Gohar & Company (Pvt) Limited, State Life Building 1B, I.I Chundrigar Road, Karachi. Manufacture by.M/s. Alcon-Couveur N.V. Rijksweg 14, B-2870, Puurs, Belgium.Site for Quality Control, Primary & Secondary Packaging.M/s Alcon Research Ltd (Subsidiary of Alcon Laboratories,

Simbrinza Eye Drops, SuspensionContains:-Brinzolamide………….10mg/mlBrimonidine Tartrate 2mg eq.to Brimonidine…….1.3mg/ ml24 months(Ophthalmic)

New Formulation

Form 5-ADy No.3323-02-2015Rs.50,000/-

EMA. Simbrinza by M/s Alcon

Original legalized COPP was issued by EMA on dated 01-09-2014.GMP issued by balgium on dated 17-05-2013Stability data not as per Zone IV A.

Deferred for the submission of stability data as per conditions of zone IV A.


Inc), ASPEX manufacturing Facility, 6201 South Freeway, Fort Worth, TX 76134-2099, USAMarket Authorization:Alcon Laboratories (UK) Ltd, Frimley Business Park, Frimley, Camberley GU16 7SR, United Kingdom.


Manufactured ByM/s. Novartis Pharma AG, Lichtstrasse 35, 4056 Basel, Switzerland. Market Authorization:Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

Signifor LAR Powder for Suspension for Injection

Each vial contains:-Pasireotide…………….20mg(as pasireotide pamoate)

(Treatment of Acromegaly) New Molecule


36 months

Form 5-A

Dy No.314 R&I dated 29-05-2015Rs.50,000/-

Rs.450,000/ 1’s

MHRA. Signifor Powder for injection 20mg, 40mg & 60mg by M/s Novartis

Orignal legalized COPP was issued by European Medicine Agency on19-02-2015.The GMP certificate says that the site is licensed to manufacture medicinal products excluded sterile

Deferred for the clarification/submission of followinga. Status of manufacturing site for the manufacturing of sterile products as GMP states that site is licensed to manufacture medicinal products excluded sterile products. b.


products. Registration application of Solvent on separate application.



Signifor LAR Powder for Suspension for Injection Each vial contains:-Pasireotide…………….40mg(as pasireotide pamoate)

(Treatment of Acromegaly) (36 months) New Molecule


36 months

Form 5-A

Dy No.315 dated 29-05-2015Rs.50,000/-

Rs.750,000/1’s

MHRA. Signifor Powder for injection 20mg, 40mg & 60mg by M/s Novartis

Orignal legalized COPP was issued by European Medicine Agency on19-02-2015.The GMP certificate says that the site is licensed to manufacture medicinal products excluded sterile products.

Deferred for the clarification/submission of followinga. Status of manufacturing site for the manufacturing of sterile products as GMP states that site is licensed to manufacture medicinal products excluded sterile products b. Registration application of Solvent on separate application.

73. M/s. Novartis Pharma (Pakistan)

Signifor LAR Powder for Suspension for Injection

Form 5-A

Dy No.313

MHRA. Signifor Powder for

Orignal legalized COPP

Deferred for the clarificatio


Limited, 15 West Wharf, Karachi.


Each vial contains:-Pasireotide…………….60mg(as pasireotide pamoate)(Treatment of Acromegaly) New Molecule


36 months

R&I dated 29-05-2015 Rs.50,000/-

Rs.1250,000/1’s

injection 20mg, 40mg & 60mg by M/s Novartis

was issued by European Medicine Agency on19-02-2015.The GMP certificate says that the site is licensed to manufacture medicinal products excluded sterile products.

n/submission of followinga. Status of manufacturing site for the manufacturing of sterile products as GMP states that site is licensed to manufacture medicinal products excluded sterile products b. Registration application of Solvent on separate application.

74. M/s. ICI Pakistan Limited,Life Sciences Business, ICI House, 5 West Wharf, Karachi

Manufactured byM/s. Eriochem S.A.Ruta 12, Km 452 (3107),

Martxel 500mg Lyophilized Powder for injection solution for intravenous infusion

Each vial contains:-Pemetrexed as disodium………….500mg


Form 5A

Dy. No 330 dated 01-06-2015 Rs.100,000/-

As per SRO



COPP issued on 29-12-2014 by Argentina is valid for 12 month.


Approved as per Import Policy for Finished Drugs. Firm will provide valid legalized CoPP and chairman will permit further


Colonia Avellaneda, Departamento Parana, Entre Rios, Argentina.


24 months

Stability data as per conditions of Zone IV-B.

processing of case

75. M/s. Pharmatec Pakistan (Pvt) Ltd., D-86/A Mangopir Road, S.I.T.E, Karachi. Manufactured ByM/s. L.MOLTENI & C, DEI F.LLI ALITTI SOCIETA’DI ESERCIZIO S.P.A. S.S.67 (TOSCO ROMAGNOLA) LOCALITA GRANATIERI-50018, ITALY.

Oramorph 2mg/ml Syrup

Each ml contains:-Morphine Sulphate………..2mg

(Natural Opium Alkaloids)

New formulation


36 months


Rs.648/100ml

MHRA. Oramorph 10mg/5ml by M/s Boehringer.

Certificate of Medicinal product 03-03-2015.GMP issued dated 07-22-2014.


76. M/s. Pharmatec Pakistan (Pvt) Ltd., D-86/A Mangopir Road, S.I.T.E, Karachi. /Manufactured ByM/s. L.MOLTENI & C, DEI F.LLI ALITTI SOCIETA’DI ESERCIZIO S.P.A. S.S.67 (TOSCO ROMAGNOLA) LOCALITA GRANATIERI-50018, ITALY.

Oramorph 20mg/ml Oral Solution

Each ml contains:-Morphine Sulphate………..20mg

(Natural Opium Alkaloids)

New formulation


36 months

Form 5A Dy. No 319 dated 01-06-2015Rs.100,000/-

Rs.829/20ml

MHRA. Oramorph 20mg/ml by M/s Boehringer

Certificate of Medicinal product 03-03-2015.GMP issued dated 07-22-2014.


77. M/s. Merixil Biopac 30mg/5ml Form 5A MHRA. COPP Approved


Pharma,Office # 28, Second Floor, Rose Plaza, I-8 Markaz, Islamabad.Manufactyured By M/s. Biolyse Pharma Corporation, 59 Welland Vale Road, ST Catharines Ontario L2S 3Y2, Canada.

Injection Each ml contains:-Paclitaxel………….…6mg


USP Specifications

30 months

Dy No. 349 dated 15-06-2015 Rs.100,000.

As per SRO.

Paclitaxel 6mg/ml Conc. for solution for infusion by M/s Medac (5ml, 16.7ml, 50ml & 100ml).


issued on 11-08-2014 by Health Canada.

GMP Compliant as per COPP.

as per Import Policy for Finished Drugs

78. M/s. Genome Pharmaceuticals (Pvt) Ltd., Plot # 16/1, Phase IV, Industrial Estate, Hattar, Distt, Haripur./

M/s. Shandong Weigao Group Medical Polymer Co., Ltd. 10 Mashan Road High-Tech Industrial Development Zone, Weihai, Shandong Province, People’s Republic of China.

Wego Single Disposable Blood BagEach 100ml of CPDA contains:-Citric acid monohydrate……..…0.327gSodium citrate dihydrate…………2.63gSodium biphosphate monohydrate…0.222gDextrose monohydrate….3.19gAdenine………0.0275gWater for injection…………q.s(Medical consumables)

Blood Bag

02 years

09-07-2015Rs.50,000/-

(Photocopy) of Certificate for Exportation of Medical Products issued by Government of China on dated.20-05-2014Original GMPis not attached

Deferred for the submission of followinga. Valid legalized COPPb. Stability data as per water loss conditions as per ICH Guidelines.

79. M/s. Genome Pharmaceuticals (Pvt) Ltd., Plot # 16/1, Phase IV,

Wego Double Disposable Blood BagEach 100ml of CPDA contains:-

09-07-2015Rs.50,000/-

(Photocopy) of Certificate for

Deferred for the submission of


Industrial Estate, Hattar, Distt, Haripur./M/s. Shandong Weigao Group Medical Polymer Co., Ltd. 10 Mashan Road High-Tech Industrial Development Zone, Weihai, Shandong Province, People’s Republic of China.

Citric acid monohydrate.…0.327gSodium citrate dihydrate………2.63gSodium biphosphate monohydrate…..0.222gDextrose monohydrate….3.19gAdenine………0.0275gWater for injection……………q.s(Medical consumables)

Blood Bag

02 years

Exportation of Medical Products issued by Government of China on dated.20-05-2014Original GMPis not attached

followinga. Valid legalized COPPb. Stability data as per water loss conditions as per ICH Guidelines.

80. M/s. Genome Pharmaceuticals (Pvt) Ltd., Plot # 16/1, Phase IV, Industrial Estate, Hattar, Distt, Haripur./M/s. Shandong Weigao Group Medical Polymer Co., Ltd. 10 Mashan Road High-Tech Industrial Development Zone, Weihai, Shandong Province, People’s Republic of China.

Wego Triple Disposable Blood BagEach 100ml of CPDA contains:-Citric acid monohydrate…0.327gSodium citrate dihydrate………2.63gSodium biphosphate monohydrate…0.222gDextrose monohydrate…..3.19gAdenine……0.0275gWater for injection…………q.s(Medical consumables)

Blood Bag

02 years

09-07-2015Rs.50,000/-

(Photocopy) of Certificate for Exportation of Medical Products issued by Government of China on dated.20-05-2014Original GMPis not attached

Deferred for the submission of followinga. Valid legalized COPPb. Stability data as per water loss conditions as per ICH Guidelines.

81. M/s. Genome Pharmaceuticals (Pvt) Ltd., Plot # 16/1, Phase IV, Industrial Estate, Hattar, Distt,

Wego Quadruple Disposable Blood BagEach 100ml of CPDA contains:-Citric acid monohydrate…0.327g

09-07-2015Rs.50,000/-

(Photocopy) of Certificate for Exportation of

Deferred for the submission of followinga. Valid


Haripur./M/s. Shandong Weigao Group Medical Polymer Co., Ltd. 10 Mashan Road High-Tech Industrial Development Zone, Weihai, Shandong Province, People’s Republic of China.

Sodium citrate dihydrate………2.63gSodium biphosphate monohydrate…0.222gDextrose monohydrate…3.19gAdenine…0.0275gWater for injection…………q.s(Medical consumables)

Blood Bag

02 years

Medical Products issued by Government of China on dated.20-05-2014Original GMPis not attached

legalized COPPb. Stability data as per water loss conditions as per ICH Guidelines.

82. M/s. Bayer Pakistan (Pvt) Limited, C-21, S.I.T.E, Karachi.

Manufacturing & Primary, Secondary Packaging and Quality Control by: M/s. Patheon Inc. Whitby Regional Operations (WRO) 111 Consumers Drive Whitby, Ontario LIN 5Z5, Canada.Market Authorization. Cubist (UK) Ltd, Unit 1 Horizon Business Village, 1 Brooklands Road, Weybridge,

Sivextro 200mg Film Coated Tablets

Each film coated tablet contains:-Tedizolid Phosphate……….200mg

(Oxazolidinone/antibiotic) New Molecule


03 years

Form 5-A

Dy No.98 30-07-2015Rs.50,000/-

Not mentioned

Original legalized COPP was issued by EMA on dated 22-05-2015.

The GMP is issued by Health Canda dated 21-04-2015 valid upto 1 year.

Release is not mentioned in COPP however the firm has submitted the

Deferred for the submission of followinga. clarification of complete details of release site as release site is not mentioned on COPP.


Surrey KT13 ORU, United Kingdom

declaration for the same. Released by:M/s. Bayer Pharma AG Mullerstrasse 178 13353 Berlin, Germany

83. M/s. Bayer Pakistan (Pvt) Limited, C-21, S.I.T.E, Karachi.

Manufactured, Quality Control & Primary Packaging by: M/s. Patheon Italia S.p.A. 2 Trav. SX Via Morolense, 5 03013 Ferentino, FR, Italy. Site Responsible for quality Control.Redox s.n.c di Arosio Antonia e. C., Viale Stucchi, 62/26, 20900 Monza (MB), Italy.Market Authorization. Cubist (UK) Ltd, Unit 1 Horizon

Sivextro Powder for Concentrate for Solution for infusion 200mg

Each vial contains:-Tedizolid Phosphate……….200mg(Oxazolidinone/antibiotic)New Molecule


03 years

Form 5-A

Dy No.42 dated 30-07-2015 Rs.50,000/-

Not mentioned

MHRA. Sivextro by M/s Merck

Original legalized COPP was issued by EMA on dated 22-05-2015.

The GMP is issued by itlay 21-08-2014.

Final Release & secondary package site is not mentioned in COPP however the firm has submitted the

Deferred for the submission of followinga. clarification of complete details of release site as release site is not mentioned on COPP.


Business Village, 1 Brooklands Road, Weybridge, Surrey KT13 ORU, United Kingdom

declaration for the same. Secondary Packaging &Released by:M/s. Bayer Pharma AG Mullerstrasse 178 13353 Berlin, Germany.

84. M/s. AJ Mirza Pharma (Pvt) Ltd., 7-Ground Floor, Shafi Court, Merewether Road, Civil Lines, Karachi.

Manufactured byM/s. Cipla Ltd., Verna Industrial Estate, Verna, India.

Cytomid 250mg Tablet

Each uncoated tablet contains:-Flutamide USP………….250mgExcipients……………….q.s.

(Treatment of Advanced prostate cancer)


Form 5A

Diary No. 179 R&I dated 20-08-2015Rs.100,000/-

RS. 4200/- 100’s

MHRA Approved


GMP compliant as per COPP. GMP valid upto 16-10-2016.


85. M/s. Novartis Pharma (Pakistan) Limited, 15 West Wharf, Karachi./Product Licence Holder:

Caflam CapsuleEach capsule contains:-Diclofenac potassium……….50mg(Anti-inflammatory and analgesic)

New Molecule

Form 5-ADy No.10603-08-2015Rs.50,000/-20’s /Rs.560

COPP was issued by Swiss Medic Switzerland on 26-01-2015

Deferred for the submission of followinga. confirmation of approval


M/s. Novartis Pharma Schweiz AG, 6343 Risch, Switzerland. Address of Manufacturing Site:M/s. Catalent Germany Eberbach GmbH Gammelsbacher Strasse 2 69412 Eberbach/Baden, Germany.

30 months Product is on the market of exporting country.The certifying authority arragge for periodic inspection not applicable.GMP certificate issued by German authorities on 07-11-2013The COPP issued by Germany says that product is not on the market for use in the exporting countries

status in reference countries as COPP issued by Germany says that product is not on the market for use in the exporting countries b. clarification of regulatory free sales status in exporting country.


Farydak 10mg Capsule

Each capsule contains:-Panobinostat………..10mg

Form 5A

Dy. No 304 Dated 08-09-2015 Rs.50,000/-

MHRA. Farydak 10mg, 15mg & 20mg by M/s Novartis.

COPP issued by US FDA for three strengths and valid

Deferred for the clarification of free sales status in


Manufactured byM/s. Novartis Farmaceutica SA, Barbera del Valles, Spain.

(Multiple Myeloma in combination with Bortezomib & Dexamethasone). New Molecule


36 months

Rs.950,000/6’s Capsules

upto 31-07-2017.The product is not available for free sale in the country of origin.GMP issued dated 12-03-2013

the exporting country.


M/s. Novartis Farmaceutica SA, Barbera del Valles, Spain.





36 months

Form 5A

Dy. No 302 dated 08-09-2015 Rs.50,000/-

Rs.1255000/6’s capsules


COPP issued by US FDA and valid upto 31-07-2017.The product is not available for free sale in the country of origin.GMP issued dated 12-03-2013

Deferred for the clarification of free sales status in the exporting country.


M/s. Novartis Farmaceutica SA, Barbera del Valles, Spain.




Form 5A

Dy. No. 301 Dated 08-09-2015 Rs.50,000/-

Rs. 1560,000/6’s capsule


COPP issued by US FDA and valid upto 31-07-2017.The product is not available for free

Deferred for the clarification of free sales status in the exporting country.



36 months

sale in the country of origin.GMP issued dated 12-03-2013

89. M/s. Pharmawell (Pvt) Ltd. 244-Y Block, Commercial Area Phase III, DHA, Lahore.

M/s. Kwangdong Pharmaceutical Co. Ltd., 114, Sandan-ro, Pyeongtack-Si, Gyeonggi-do, Republic of Kora.

Lenara 2.5mg Tablets

Each film coated tablet contains:-Letrozole…….2.5mg

(Adjuant treatment of post-menopausal women with harmone recpotor positive invasive early breast cancer).

(USP Specs)

36 months

Form 5A

Dated 15-09-2015 vide diary No. 399 Rs.100,000/-

Rs.6,0000/30’s



COPP issued dated 30-06-2015 vide no. 2015-D1-1817.GMP issued dated 27-07-2015 vide no. 2015-D1-2068.Stability data as per conditions of Zone IV B attached.

Approved as per Import Policy for Finished Drugs.Panel shall confirm the anticancer facility for the manufacturing of the drug at the time of foreign inspection


Product License Holder:-M/s. Novartis Pharma Stein AG, Stein, Switzerland.Manufacturer:M/s. Novartis

Entresto to Uperio 200mg

Each film coated tablet contains:- Sacubitril/Valsartan 226.206mg (Corresponds to Sacubtril/Valsartan free anhydrous acid) 200mg Sacubitril/Valsartan Sodium salt Hydrate, Crystal modification A Scubitril/Valsartan 200mg Corrosponds to

Form 5A

Dy No. 329 dated 30-09-2015Rs.50,000/-

Rs.27240/28tablets

COPP was issued by Swiss Medic Switzerland on 17-09-2015GMP compliant as per COPP.COPP mentioning two



Pharma Stein AG, Stein, Switzerland.

M/s. Novartis Singapore Pharmaceutical Manaufacturing Ptc. Ltd., 10 Tuas Bay Lane 637461 Singapore, Singapore.

Sacubitril 97.2mg and Valsartan 102.8mg

(Treatment of Heart Failure)New Molecule24 months

manufacturers without detaisl of manufacturing processes.

91. M/s. Highnoon Laboratories Limited, 17.5 KM, Multan Road, Lahore. /M/s. Cipla Ltd.,Village Malpur, Baddi District Solan, Himachal Pradesh, India.

Pirfenex 200mg TabletEach film coated tablet contains:-Pirfenidone………200mg

(Idiopathic Pulmonary Fibrosis)New Molecule

24 months

Form 5-ADy No.28730-09-2015Rs.100,000/-

COPP and GMP was issued by India on dated 21-04-2015 valid up to 29-08-2017

Deferred for the confirmation of approval status in reference countries.

92. M/s. Merixil Pharma,Office # 28, Second Floor, Rose Plaza, I-8 Markaz, Islamabad. Manufactured byM/s. Eirgen Pharma Ltd. 64/65 Westside Business Park Old Kilmeaden Road, Waterford, Ireland.

Temoeirgen 20mg Capsules

Each capsule contains:-Temozolamide……….20mg



24 months

Form 5A dy. No. 381 dated 09-10-2015 Rs.100,000/-

As per SRO /5’s



COPP issued on 04-02-2015. GMP compliant as per COPP.


93. M/s. Gene-Tech Laboratories,Head Office.

Osateofil Solution for Injection

Form 5A

Dy No. 397

MHRA. Bondronat 2mg/2ml by

COPP No. 2014-

Deferred for the submissio


246/B, PECHS, Block-6, Karachi.

Manufactured byM/s. Nanjing Hencer Pharmaceutical Co. Ltd., No. 18 Jichang Road, Lishui Economic & Technological Development Zone, Nanjing City, Jiangsu Province, China.

Each vial contains:-Ibandronate Sodium………2mg/2ml

(Nitrogen –containing group of Bisphosphonates)

Prevention of skeletal muscle events in patients with Breast Cancer and Bone Metastasis

3 years

R&I dated 15-10-2015Rs.100,000/-

Rs.8650/vial

M/s Roche 146-1 issued dated 29-09-2014 valid upto 2 years.

GMP certificate valid upto 08-04-2018 No. CN20130099.

n of following a. Stability data as per conditions of Zone IV A.b. Drugs sales licensec. Sole agency Agreement

94. M/s. Merixil Pharma,Office # 28, Second Floor, Rose Plaza, I-8 Markaz, Islamabad. /M/s. Laboratorios Normon, S.A. Ronda De Valdecarrizo, 6, Tres Cantos, 28760, Madrid, Spain.

Exemestane Normon 25mg Tablet

Each coated tablets contains:-Exemestane……………25mg

(Treatment of postmanupausal woman with oestrogen positive invasive breast cancer)


24 months


As per SRO/3x10’s tablets

COPP not provided.

Deferred for the submission of followinga. Stability data as per ICH guidelines b. Valid legalized COPP.

95. M/s. Merixil Pharma,Office # 28, Second Floor, Rose Plaza, I-8 Markaz, Islamabad. Manufactured ByM/s.

Zoledronic Acid Normon 4mg/5ml Injectable

Each 5ml concentrate vial contains:-Zoledronic acid Monohydrate 4.264mg eq to zoledronic acid……….4mg

Form 5A

Dy. No. 546 R&I dated 22-12-2015 Rs.100,000/-

As per

MHRA. Zoledronic Acid 4mg/5ml by M/s Intrapharm.

COPP issued on 24-02-2016.




Laboratorios Normon, S.A. Ronda De Valdecarrizo, 6, Tres Cantos, 28760, Madrid, Spain.

(Prevention of skeletal related events (e.g tumor induced hypercalcemia) in adult patients with advanced malignancies involving bone).


24 months

SRO GMP issued 13-06-2014.

96. M/s. Merixil Pharma,Office # 28, Second Floor, Rose Plaza, I-8 Markaz, Islamabad. Manufactured byM/s. Laboratorios Normon, S.A. Ronda De Valdecarrizo, 6, Tres Cantos, 28760, Madrid, Spain.

Ondansetron Normon 8mg Injection

Each 4ml vial contains:-Ondansetron………….8mg (as hydrochloride dihydrate)


Manufacturer’s Specifications36 months

Form 5A Dy. No 548 Dated 22-12-2015 Rs.100,000/-

As per SRO/ 1x5 ampoules

MHRA.Ondansetron 2mg/ml by M/s Hameln


GMP Compliant as per COPP.

GMP issued dated 13-06-2014.


97. M/s. Medi Mark Pharmaceuticals,Liaqut Chowk, Sahiwal./M/s. Zhejiang Xianju Pharmaceuticals Co. Ltd., No.6, Xingye Road, Modern Block, Ecnomic Zone, Xianju, Zhejiang, China.

Xmeron 50mg Injection Each ml contains:-Rocuronium Bromide……..10mg(Muscle relaxants, peripherally acting agents)24 months

Form 5-ADy No.23-12-2015Rs.100,000/-

China Council for the Promotion of International Trade china chamber of international commerce issued

Deferred for confirmation whether formulation is already registered or otherwise


Original legalized COPP 25-09-2015 valid upto 24-09-2016.FSC issued by Xianju Food and Drug Administration of China 25-09-2015 valid upto 24-09-2016



Manufactured byM/s. United Biotech (P) Limited, Bagbania, Baddi-Nalagarh Road, District-Solan (Himachal Pradesh) 174101, India.

Oncotar-500 Injection Each ml contains:-Cytarabine BP…………….100mg

(Acute myeloid leukaemia and for other acute leukaemias for children and adults)

USP Specifications2 years

Form 5A

Dy. NO 616 dated 31-12-2015Rs.50,000/-& 50,000 dated 24-06-2016.

As per PRC

MHRA. Cytarabine 500mg/5ml by M/s Hospira.

Local. Cytarine 500mg by M/s Atco

Free sale issued dated 26-02-2016. COPP valid up to 10-05-2017

Photocopy of GMP is legalized valid upto 17-09-2017.




Egymelan 50mg Injection

Each vial contains:-Melphalan Hydrochloride

Form 5A

Dy. No 617 dated 31-12-2015 Rs.50,000/-

MHRA. Melphalan 50mg powder for injection by M/s Aspen.


Photocop



Manufactured ByM/s. United Biotech (P) Limited, Bagbania, Baddi-Nalagarh Road, District-Solan (Himachal Pradesh) 174101, India.

eq. to Melphalan (Anhydrous)…….50mg

(Multiple Myeloma and Ovarian Cancer) New Molecule


As per SRO.

y of GMP valid upto 17-09-2017.




K-Styrn 15gm Sachet

Each sachet contains:-Calcium Polystyrene Sulfonate………15gm

(Potassium Binder)


Form-5A

Dy No.61331-12-2015Rs.50,000/-

Japan. Polystryene Sulphonate Sachet 15gm.

Free sale issued dated 26-02-2016. COPP valid up to 10-05-2017.

Leglalized photocopy of GMP valid upto 17-09-2017




M/s. United Biotech (P) Ltd., Village Bagbania, Baddi-Nalagarh Road, District-Solan (Himachal Pradesh)

Amphotin Lip-50 Injection

Each vial contains:-Amphotericin B Lipid Complex…50mg

(Antifungal)


Form 5A

Dy No. 61431-12-2015Rs.50,000/-

As per PRC

MHRA. Abelcet 5mg/ml Amphotericin B lipid complex(10ml, 20ml) Concen. For infusion by M/s Teva.

Free sale issued dated 26-02-2016.COPP valid upto 10-5-2017 Legalized photocopy of GMP valid

Deferred as the product does not fall in the priority list. Moreover Anti-fungal drugs are not importable from India as per


174101, India. upto 17-09-2017.

Import Policy Order, 2016



M/s. United Biotech (P) Ltd., Village Bagbania, Baddi-Nalagarh Road, District-Solan (Himachal Pradesh) 174101, India.

Vonaz 200 Injection Each ml contains:-Voriconazole….200mg

(Antifungal)


Form 5A

Dy No. 615 dated 31-12-2015 Rs.50,000/-

As per PRC

MHRA. Vfend 200mg powder for infusion by Pfizer.

Free sale issued dated 26-02-2016. COPP valid upto 10-5-2017. GMP valid upto 17-09-2017.

Deferred as Anti-fungal drugs are not importable from India as per Import Policy Order, 2016.



Manufactured byM/s. GENFARMA LABORATORIO, S.L. Site address Avda. De la Constitucion, 198-199 Poligono Industrial Monte Boyal, Casarrubios del Monte 45950 (Toledo) Espana, Spain. Market Authorization

Colicraft 1,000,000 IU powder for solution for Injection

Each vial contains:-Colistimethate Sodium …1,000,000 I.U

(Antibiotic)/Polymyxin )

USP Specifications

03 years

Form 5A

Dy No. 61931-12-2015Rs.50,000/-

As per PRC

MHRA. Colomycin 1MIU by M/s Forest.

COPP issued dated 04-05-2016.

Firm is GMP compliant as per COPP.



Holder.M/s G.E.S Genericos Espanoles Laboratorio, S.A Colquide,6- Portal, Spain

104. M/s. Servier Research and Pharmaceuticals Pakaistan Private Limited, 65 Main Boulevard Gulberg, Lahore.

M/s. Les Laboratoirie Industrie, 905, route de Saran 45520 Gidy, France.

Implicor Film Coated TabletsEach film coated tablet contains:-Metoprolol Tartrate………….50mgIvabradine…………………….5mg(Antianginal)18 months

Form 5A

Dy no. 172 dated 10-02-2016 Rs.100,000/-

COPP (Photocopy) was issued by France on dated 18-09-2015.GMP photocopy attachedStability data is not as per conditions of Zone IV A however stress stability data attached.

Deferred for the submission of followinga. Valid legalized COPP b.Stability data as per conditions of zone IV A.c. Approval status in reference countries.

105. M/s. AJ Mirza Pharma (Pvt) Ltd., 7-Ground Floor, Shafi Court, Merewether Road, Civil Lines, Karachi. M/s. Cipla Ltd, S-103 to S-105, S-107 to S-112, L-138, L-147, L-147/1 to L-147/3, L-147/A, Verna Industrial

Finpecia Film Coated Tablets

Each film coated tablets contains:-Finasteride USP…………1mg

(Anti Androgenic)36 months

Form 5A

Dy No.174 dated 12-02-2016 Rs.100,000/-

As per SRO

COPP valid upto 16-10-2016.GMP compliant as per COPP.

Defered as the product does not fall in the priority list.


Estate, Verna, Goa.

106. M/s. Genix Pharma (Private) Limited, 44-45-B, Korangi Creek Road, Karachi-75190. /Manufactured by :-M/s. NOBILUS ENT Swarszewska 45, 01-821 Warsaw, Poland.Supplying Agent:M/s. Labosuan S.L. calle Einsten 8-28108 Alcobendas, Madrid, Spain.

Genitinib 100mg Hard Gelatin Capsule

Each capsule contains:-Imatinib Mesilate eq. Imatinib………………..100mg


Shelf Life 2 years(Vol. 1 of 3 )


MHRA. Glivec 100mg & 400mf f/c tablet by M/s Novartis.

COPP, GMP & stability data not attached.Form 5A is incomplete.Finish product specifications are not attached.

Deferred for the submission of followinga.Valid Legalized COPPb. Stability data as per conditions of Zone IV A.c. Completion of Form 5A.d. Finish product specifications.

107. M/s. Genix Pharma (Private) Limited, 44-45-B, Korangi Creek Road, Karachi-75190. /Manufactured by :-M/s. NOBILUS ENT Swarszewska 45, 01-821 Warsaw, Poland.Supplying Agent:M/s. Labosuan S.L. calle Einsten 8-28108

Genitinib 400mg Hard Gelatin Capsule

Each capsule contains:-Imatinib Mesilate eq. Imatinib………………..400mg


Shelf Life 2 years

Form 5A

Dy. No 313 dated 04-03-2016 Rs.100,000/-



COPP, GMP & stability data not attached.Form 5A is incomplete.Finish product specifications are not attached.

Deferred for the submission of followinga.Valid Legalized COPPb. Stability data as per conditions of Zone IV A.c. Completion of Form 5A.d. Finish product specificati


Alcobendas, Madrid, Spain.

ons.

108. M/s. Genix Pharma (Private) Limited, 44-45-B, Korangi Creek Road, Karachi-75190. /Manufactured by:M/s. Samyang Genex Corporation, 1688-3, Sinil-dong Daedeok-gu Daejeon 306-220, Korea.Analytical Testing & Batch Release by:M/s. Aq Vida GmbH Kaiser-Wilhelm-Str.89 20355 Hamburg, Germany.Marketing Authorization Holder:M/s. Labosuan S.L. calle Einsten 8-28208 Alcobendas, Madrid, Spain.

Genoxaltin 50mg Powder for Infusion

Each vial contains:-Oxaliplatin………..50mg

Treatment of metastatic colorectal cancer)

Shelf Life 3 years

Form 5A

Dy. 208 dated 02-03-2016Rs.100,000/-

Not provided.

MHRA. Oxaliplatin 50mg & 100mg powder for solution for infusion by M/s Actavis.

COPP issued dated 19-03-2016 COPP strength is mentioned as 5mg/mlPack sizes are not mentioned on COPP.GMP compliant as per COPP.Single COPP for 2 products.

Deferred for the clarification of strength 5mg/ml on COPP whereas the firm has applied in powder form in Form 5A.

109. M/s. Genix Pharma (Private) Limited, 44-45-B, Korangi Creek Road, Karachi-75190. /Manufactured by:M/s. Samyang

Genoxaltin 100mg Powder for Infusion

Each vial contains:-Oxaliplatin………..100mg

Treatment of metastatic colorectal cancer)

Form 5A

Dy. No 209 dated 02-03-2016Rs.100,000/-

MHRA. Oxaliplatin 50mg & 100mg powder for solution for infusion by M/s Actavis.

COPP issued dated 19-03-2016 COPP strength is mentioned as 5mg/ml

Deferred for the clarification of strength 5mg/ml on COPP whereas the firm has


Genex Corporation, 1688-3, Sinil-dong Daedeok-gu Daejeon 306-220, Korea.Analytical Testing & Batch Release by:M/s. Aq Vida GmbH Kaiser-Wilhelm-Str.89 20355 Hamburg, Germany.Marketing Authorization Holder:M/s. Labosuan S.L. calle Einsten 8-28208 Alcobendas, Madrid, Spain.

Shelf Life 3 years


applied in powder form in Form 5A.

110. M/s. Genome Pharma,House # 593-B, Street # 10, Chaklala Scheme III, Rawalpindi.

Manufactcured by M/s. "Belmedpreparaty" RUE, 30 Fabritsius Str. 220007 Minsk, Republic of Belarus.

Zoledron Lyophilized Powder for Solution for Infusion

Each vial contains:-Zoledronic Acid (as Zoledronic acid monohydrate)……………………4mg

(Prevention of skeletal related events(e.g tumor induced hypercalcemia) in adult patients with advanced malignancies involving bone).


02 years

Form 5A

Dy. No 246 dated 14-03-2016Rs.100,000/-As per SRO


Documents are not legalized. COPP issued on 31-07-2015 by Republic of Belarus. GMP compliant as per COPP.GMP valid upto 10-10-2017.



111. M/s. Genome Pharma,House # 593-B, Street # 10, Chaklala Scheme III, Rawalpindi./Manufactcured by M/s. "Belmedpreparaty" RUE, 30 Fabritsius Str. 220007 Minsk, Republic of Belarus.

Gemcitabel Lyophilized Powder for Solution for Infusion

Each vial contains:-Gemcitabine Hydrochloride …1000mg



Form 5A

Dy. No 237 R&I 14-03-2016Rs.100,000/-

AS per SRO


Approved as per Import Policy for Finished Drugs. Firm has provided valid legalized CoPP

112. M/s. Genome Pharma,House # 593-B, Street # 10, Chaklala Scheme III, Rawalpindi.

Manufactcured by M/s. "Belmedpreparaty" RUE, 30 Fabritsius Str. 220007 Minsk, Republic of Belarus.

Gemcitabel Lyophilized Powder for Solution for Infusion

Each vial contains:-Gemcitabine Hydrochloride ..200mg


USP Specifications

02 years

Form 5A

Dy. No. 236 dated 14-03-2016Rs.100,000/

As per SRO


Approved as per Import Policy for Finished Drugs. Firm has provided valid legalized CoPP

113. M/s. Genome Pharma,House # 593-B, Street # 10,

Methobel Lyophilized Powder for Solution for Injection

Form 5A

Dy. 238 R&I dated

Documents are not legalized

Approved as per Import Policy for


Chaklala Scheme III, Rawalpindi./Manufactcured by M/s. "Belmedpreparaty" RUE, 30 Fabritsius Str. 220007 Minsk, Republic of Belarus.

Each vial contains:-Methotrexate as sodium……..50mg

(Antineoplastic drug)


14-03-2016Rs.100,000/

As per PRC

. COPP issued on 31-07-2015 by Republic of Belarus. GMP compliant as per COPP.GMP valid upto 10-10-2017.

Finished Drugs. Firm has provided valid legalized CoPP

114. M/s. Genome Pharma,House # 593-B, Street # 10, Chaklala Scheme III, Rawalpindi.Manufactcured by M/s. "Belmedpreparaty" RUE, 30 Fabritsius Str. 220007 Minsk, Republic of Belarus.

Anastrozole-Belmed Film Coated Tablets

Each film coated tablets contains:-Anastrozole………….1mg



02 years

Form 5A

Dy. No 239 dated 14-03-2016Rs.100,000/

As per PRC

MHRA. Anastrozole 1mg f/c by M/s consilent.

Local. Anastrozole 1mg by M/s Pfizer


Approved as per import Policy for Finished Drugs, as firm has provided valid legalized CoPPprovided.Panel shall confirm the anticancer facility for the manufacturing of the drug at the time of foreign inspection

115. M/s. LDS (Pvt) Ltd.,57/1 A Satellite Town, Rawalpindi-Pakistan.

Temozol 20 Capsules

Each hard gelatin capsule contains:-Temozolomide……………20mg

Form 5ADy.No. 314 R&Idated 22-04-2016Rs.50, 000/- &


COPP valid up to 2-8-2016. GMP

Approved as per import Policy for Finished Drugs


Manufactured by:-M/s. Khandelwal Laboratories Pvt. Ltd., Plot B-1, Wagle Industrial Estate, Thane-400 604, Maharashtra, India.


Manufacture’s Specifications

24 months

50,000 18-03-2016. Local.

Temoside 20mg, 100mg & 250mg by M/s AJ. Mirza.

valid upto 02-08-2016.

116. M/s. LDS (Pvt) Ltd.,57/1 A Satellite Town, Rawalpindi-Pakistan.

Manufactured by:-M/s. Khandelwal Laboratories Pvt. Ltd., Plot B-1, Wagle Industrial Estate, Thane-400 604, Maharashtra, India.

Temozol 100 Capsules Each hard gelatin capsule contains:-Temozolomide……………100mg


Manufacturer’s specifications.

24 months

Form 5ADy No.315 R&I22-04-2016Rs.50,000/- & Rs.50,000 dated 18-03-2016.





117. M/s. LDS (Pvt) Ltd.,57/1 A Satellite Town, Rawalpindi-Pakistan. /Manufactured by:-M/s. Khandelwal Laboratories Pvt. Ltd., Plot B-1, Wagle Industrial Estate, Thane-400 604,

Doxorubin 50 Hydrochloride for injection

Each vial contains:-Doxorubicin Hydrochloride USP……………….50mgLactose USP………q.s.

(Small cell lung cancer, Breast cancer, bladder carcinoma, Hodgkin’s disease)

Form 5A Dy. 311 Dated 22-04-2016Rs.50,000/- &Rs.50,000 dated 18-03-2016.

Rs.1625/Vial

MHRA. Doxorubicin 50mg by M/s Teva

Local. Adrim by M/s Atco

COPP valid upto 02-08-2016 . GMP valid upto 02-08-2016 .

Deferred for the clarification of the followinga.Fresh Sole agency agreement as clarification of the status of registration letter as


India.USP Specifications

30 months

the products are already approved in 227th

meeting with M/s Scarlet.

118. M/s. LDS (Pvt) Ltd.,57/1 A Satellite Town, Rawalpindi-Pakistan. /Manufactured by:-M/s. Khandelwal Laboratories Pvt. Ltd., Plot B-1, Wagle Industrial Estate, Thane-400 604, India.

Epichlor 10 Powder for injection (Lyophilized) Each vial contains:-Epirubicin Hydrochloride BP…………10mg

(Used in Neoplastic conditions breast, ovarian, Gastric, lung and Colorectal carcinomas, Malignant lymphomas)

36 months

Form-5A

Dy No. 404 R&I-dated 18.03.2016

Rs50000/- dated 18-03-2016Balance Rs50000/- dated 22-04-2016

MHRA. Epirubicine 10mg & 50mg powder for solution for injection by M/s Actavis

Local. Anthracin 50mg & 10mg by M/s Atco

COPP valid up to 2-8-2016 GMP valid upto 02-08-2016. .



Epichlor 50 Powder for injection (Lyophilized)

Each vial contains:-Epirubicin Hydrochloride BP…………50mg

(Used in Neoplastic conditions breast, ovarian, Gastric, lung and Colorectal carcinomas, Malignant lymphomas)

Manufacture’s Specifications36 months

Form 5A Dy. No 313 R&I dated 22-04-2016Rs.50,000/- & Rs.50,000 dated 18-03-2016.

Rs. 2540/- per vial

MHRA. Epirubicine 10mg & 50mg powder for solution for injection by M/s Actavis

Local. Anthracin 50mg & 10mg by M/s Atco



120. M/s. LDS (Pvt) Doxorubin 10 Form 5A MHRA. Photocop Deferred


Ltd.,57/1 A Satellite Town, Rawalpindi-Pakistan. Manufactured by:-M/s. Khandelwal Laboratories Pvt. Ltd., Plot B-1, Wagle Industrial Estate, Thane-400 604, India.

Hydrochloride for injection

Each vial contains:-Doxorubicin Hydrochloride USP………….10mgLactose USP…q.s.

(Small cell lung cancer, Breast cancer, bladder carcinoma, Hodgkin’s disease)

USP Specifications

30 months

Dy. 312 Dated 22-04-2016Rs.50,000/- &Rs.50,000 dated 18-03-2016.

Rs.490/Vial

Doxorubicin 10mg by M/s Teva

Local. Adrim by M/s Atco

y of COPP valid upto 02-08-2016. Photocopy of GMP valid upto 02-08-2016.

for the clarification of the followinga.Fresh Sole agency agreement as clarification of the status of registration letter as the products are already approved in 227th



Oncomide 1000 Powder for injection

Each vial contains:-Cyclophosphamide anhydrous 1.07gm Equivalent to Cyclophosphamide…..1.00gm

(Chronic Lymphocytic Leukaemis &Acute Lymphocytic Leukaemis)

USP Specifications

36 months

Form 5A Dy. No 316 dated 22-04-2016Rs.50,000/- & 18-03-2016 Rs.50,000.

Rs.230/vial

MHRA. Cyclophosphamide 1000mg by M/s Baxter

Local. Zyman by M/s Al-Habib

Photocopy of COPP valid upto 02-08-2016Photocopy of GMP valid upto 02-08-2016.

Deferred for the clarification of the followinga.Fresh Sole agency agreement as clarification of the status of registration letter as the products are already approved in 227th



122. M/s. LDS (Pvt) Ltd.,57/1 A Satellite Town, Rawalpindi-Pakistan.Manufactured by:-M/s. Khandelwal Laboratories Pvt. Ltd., Plot B-1, Wagle Industrial Estate, Thane-400 604, India.

Bortemib 3.5 Powder for Injection (Lyophilized)

Each vial contains:-Bortezomib…………3.5mg



24 months

Form 5ADy. NO 407 dated 18-03-2016 Rs.50,000/-

Rs.27500/vial

MHRA. Velcade 3.5gm powder for solution for injection.

COPP valid upto 02-08-2016 . GMP valid upto 02-08-2016 . Internationaly the product is present as mannitol boronic ester.

Deferred for the clarification as product is approved by reference regulatory authorities as mannitol boronic ester form.

123. M/s. LDS (Pvt) Ltd.,57/1 A Satellite Town, Rawalpindi-Pakistan./Manufactured by:-M/s. United Biotech (P) Ltd.,Bagbania, Baddi-Nalagarh Road, District Solan, Himachal Pradash-174 101, India.

Unilistin Colistimethate Sodium for Injection BP 1 Million IUEach vial contains:-Colistimethate Sodium BP……1,000,000 IU

Form 5-A

Dy.No.318 25-04-2016 Rs.50,000/-

Antibiotics are not importable from India. Sole agency agreement is not provided.FSC issued dated 26-1-2016.Stability data as per zone-IV is not providedFinish product specifications are not

Deferred as the product is a me too not a new drug.


provided.

124. M/s. Genix Pharma (Private) Limited, 44-45-B, Korangi Creek Road, Karachi-75190. /Manufactured by :-M/s. Jiangsu Hengrui Medicine Co. Ltd., UNo.38 Huanghe Road, Lianyungang Economic and Technological Development Zone, Jiangsu, China.

Leeza 2.5mg Tablets

Each film coated tablets contains:-Letrozole………….2.5mg


USP Specifications.02 years

Form 5A

Dy No. R&I Dated 19-09-2016 Rs.100,000/-



Fee Rs 100,000 is a photocopy.Dossier is a duplicate.COPP valid upto 18-02-2018.GMP compliant as per COPP.GMP valid upto 18-02-2018.

Approved as per Import Policy for Finished Drugs. Panel shall confirm the anticancer facility for the manufacturing of the drug at the time of foreign inspection. Chairman RegistratiBoard is authorized for the issuance of Registration letter after verification of fee from Budget & Accounts.

125. M/s. Graton Pharma,Suit No. 102, The Plaza, Clifton 2 Talwar, Karachi.Manufactured byM/s. Yangtze River

Zoltran Injection 4mg/5ml Each vial contains:-Zoledronic acid……..4mg

(Prevention of skeletal related events(e.g tumor induced

Form 5A

Dy. No 348 Dated 20-04-2016Rs.100,000/

As per SRO


Free sales certificate issued on 27-01-2016. GMP valid upto 13-03-2018



Pharmaceutical Group Sichuan Hairong Pharmaceutical Co. LTd., Dujiangyan High Tech Development Zone, Sichuan, China.

hypercalcemia) in adult patients with advanced malignancies involving bone).


126. M/s. Graton Pharma,Suit No. 102, The Plaza, Clifton 2 Talwar, Karachi.Manufactured byM/s. Yangtze River Pharmaceutical Group Co. Ltd 1 South , Yangtze River Road, Taizhou, Jiangsu, 225321 China.

Grataxel 100mg/16.7ml injection

Each vial contains:-Paclitaxel………….100mg


USP Specifications

03 years

Form 5A

Dy. No. 1026 Dated 18-04-2016Rs.100,000/

As per SRO



COPP 18-04-2016.

Approved

127. M/s. Roche Pakistan Limited,37-C, Bock-6, P.E.C.H.S. Karachi./M/s. Made for Roche Registration Limited, Welwyn Garden City, UK by F. Hoffmann-La Roche Ltd., Basel, Switzerland manufacturing

Esbriet Hard Capsules Each hard capsules contains:-Pirfenidone…..267mg

(Anti-fibrotic agent)

New Molecule

4 years

Form 5-ADy No.35029-04-2016Rs.50,000/-

FDA. Esbriet by M/s Genetech.

Orignal legalized COPP is not provided.

Deferred for the submission of following a.valid legalized COPP b.Stability data as per conditions of Zone IV A.


Site Catalent Pharma Solutions LLC, Winchester (KY), USA.



Manufactured byM/s. United Biotech (P) Limited, Bagbani, Baddi, Nalagarh Road, District, Solan, India.

Octreotide 50mcg Injection

Each vial of ampoule contains:-Octreotide acetate equivalent to 0.05mg milligrams of octreotide ……50mcg

(Acromegaly/Carcinoid Tumors/Vasoactive Intestinal tumors)


03 years

Form 5A

Dy No. 357 dated29-04-2016Rs.50,000/- & 50,000 dated 24-06-2016.

As per SRO

FDA. Sandostatin 50mcg/ml by M/s Novartis.

Local. Sandostatin 0.05mg/ml & 0.1mg/ml by M/s Novartis.





Manufactured byM/s. United Biotech (P) Limited, Bagbani, Baddi, Nalagarh Road, District, Solan, India.

Octreotide 100mcg Injection

Each vial of ampoule contains:-Octreotide acetate equivalent to octreotide …100mcg

(Acromegaly/Carcinoid Tumors/Vasoactive Intestinal tumors)


Form 5A

Dy. 356 Dated 29-04-2016 Rs.50,000/-& 50,000 dated 24-06-2016.

As per SRO.

FDA. Sandostatin 100mcg/ml by M/s Novartis.

Local. Sandostatin 0.05mg/ml & 0.1mg/ml by M/s Novartis.

Free sale issued dated 26-02-2016. COPP valid upto 10-5-2017. GMP valid upto 17-09-2017


130. M/s. Revive Health Care,

Vasmed Injection Form-5 A MHRA. Vasopressin

Free sale certificat

Approved as per


Office 503, 5th



Each ampoule contains:-Synthetic Vasopressin….20 IU

(Synthetic Hormone) New Molecule

USP specifications

03 yearts

Dy No 354.29-04-2016Rs.50,000/-

As per PRC

20IU/ml by M/s par Sterile.

e issued on 26-02-2016. COPP valid upto10-5-2017. GMP valid upto 17-09-2017.

import Policy for Finished Drugs




Vinotec 50mg Injection

Each vial of 5ml contains:-Vinorelbine as Tartrate eq. to Vinorelbine…….50mg

(Stage III & IV small cell lung cancer, Advance Breast cancer for stage III & IV)

USP Specifications

03 years

Form 5A

Dy. No 359 Dated 29-04-2016 Rs.50,000/- & 50,000 dated 24-06-2016.

As per PRC.

MHRA. Navelbine 10mg/ml (5ml) by M/s Pierre.

Local. Vilne by M/s Ghani Brothers



132. M/s. Revive Health Care, Office No.503, 5th Floor, 6 Main Gulberg, Jail Road, Lahore.

M/s. GENFARMA LABORATORIO, S.L. Site address Avda. De la Constitucion,

Colicraft 2,000,000 IU Lypholized powder for solution for Injection

Each vial contains:-Colistimethate Sodium …2,000,000 I.U

(Antibiotic)/Polymyxin )

USP Specifications

03 years

Form 5A

Dy No.358 R&I dated 29-04-2016 Rs.50,000/-

As per PRC.

MHRA. Colomycin 1MIU & 2 MIU by M/s Forest.

COPP was issued by Spain on dated 04-05-2016. GMP compliant as per COPP dated 04-05-2016.

Deferred for confirmation whether formulation is me too or otherwise


198-199, Poligono Industrial Monte Boyal, Casarrubios del Monte 45950 (Toledo) Espana, Spain.



Market authorization holder M/s. MEDAC,Gesellschaft fur klinische Spezialpraparate mbH, Fehlandtstrasse 3 20354 Hamburg, Germany. Labelling, Secondary Packaging, Quality Control/testing & Batch release byM/s. MEDAC,Gesellschaft fur klinische Spezialpraparate mbH, Theaterstr, 6, 22880 Wedel, Germany.Manufactured by M/s Oncotec

Irinotecan medac 100mg/5ml Injection

Each vial contains:-Irinotecan……..100mg



03 years

Form 5A

Dy. No 362 Dated 29-04-2016 Rs.100,000/-

As per SRO/5ml

MHRA. Campto 20mg/ml (100mg/5ml) Conc. For solution for infusion by M/s Pfizer.

Local. CPT-11 injection by M/s Medinet.

COPP issued dated 18-04-2016.GMP compliant as per COPP.



pharma produktin GmbH, Am Pharmapark, 06861 Dessau-Rosslau, Germany.



Manufactured by M/s. CSPC Ouyi Pharmaceutical Co. Ltd., No.88, Yangzi Road, Shijiazhuang City of China.

LipAd Injection

Each vial contains:-20mg Doxorubicin Hydrochloride in 10ml pegylated liposomal

(Alone for meta-static breast cancer, advanced ovarian cancer. In combination with Bortezomide for treatment of progressive multiple myeloma.)


24 months

Form 5A

Dy. No 362 dated 29-04-2016 Rs.100,000/-

As per SRO.

MHRA. Caelyx 2mg/ml conc. For solution for infusion.

Local. Doxopeg by M/s Ferozsons.

Free sale issued dated 12-04-2016. GMP of the manufacturing place not provided.




Market authorization holder M/s. MEDAC,Gesellschaft fur klinische Spezialpraparate mbH, Fehlandtstrasse 3 20354

Temomedac 100mg Capsule Each capsule contains:-Temozolomide………100mg



Form 5A

Dy. No 363 Dated 29-04-2016 Rs.100,000/-

As per SRO.






Hamburg, Germany. Labelling, Secondary Packaging, Quality Control/testing & Batch release byM/s. MEDAC,Gesellschaft fur klinische Spezialpraparate mbH, Theaterstr, 6, 22880 Wedel, Germany.Manufactured by M/s Oncotec pharma produktin GmbH, Am Pharmapark, 06861 Dessau-Rosslau, Germany.


Floor Rose 1, Plaza I-8 Markaz, Islamabad.Market authorization holder M/s. MEDAC,Gesellschaft fur klinische Spezialpraparate mbH, Fehlandtstrasse 3 20354 Hamburg, Germany.

Paclitaxel medac 100mg/16.7ml Injection

Each vial contains:-Paclitaxel…………100mg

(Monotherapy for meta-static breast cancer. In combination with Gemcitabin for meta-static adenocarcinoma of pancreas))

USP Specifications

Form 5 A

Dy. NO 364 dated 29-04-2016 Rs.100,000/-

As per SRO/16.7ml.



COPP issued dated 18-04-2016.GMP compliant as per COPP.Single COPP for two products.



Labelling, Secondary Packaging, Quality Control/testing & Batch release byM/s. MEDAC,Gesellschaft fur klinische Spezialpraparate mbH, Theaterstr, 6, 22880 Wedel, Germany.Manufactured by M/s Oncotec pharma produktin GmbH, Am Pharmapark, 06861 Dessau-Rosslau, Germany.

03 years


Floor Rose 1, Plaza I-8 Markaz, Islamabad.Market authorization holder M/s. MEDAC,Gesellschaft fur klinische Spezialpraparate mbH, Fehlandtstrasse 3 20354 Hamburg, Germany. Labelling, Secondary

Paclitaxel medac 300mg/50ml Injection Each vial contains:-Paclitaxel…………300mg


USP Specifications

03 years

Form 5A

Dy.363 dated 29-04-2016 Rs.100,000/-

As per SRO/50ml.



COPP issued dated 18-04-2016.GMP compliant as per COPP..



Packaging, Quality Control/testing & Batch release byM/s. MEDAC,Gesellschaft fur klinische Spezialpraparate mbH, Theaterstr, 6, 22880 Wedel, Germany.Manufactured by M/s Oncotec pharma produktin GmbH, Am Pharmapark, 06861 Dessau-Rosslau, Germany.



Market authorization holder M/s. MEDAC,Gesellschaft fur klinische Spezialpraparate mbH, Fehlandtstrasse 3 20354 Hamburg, Germany. Labelling, Secondary Packaging,

Topotecan medac 4mg Injection Each vial contains:-Topotecan as Hydrochloride……..4mg

(Small cell Lung Cancer treatment)


Form 5A

Dy. No 360 Dated 29-04-2016 Rs.100,000/-

As per SRO.

FDA. Topotecan 1, 3 & 4mg solution for injection by M/s Sandoz.

Local. Hycamtin by M/s GSK




Quality Control/testing & Batch release byM/s. MEDAC,Gesellschaft fur klinische Spezialpraparate mbH, Theaterstr, 6, 22880 Wedel, Germany.Manufactured by M/s Oncotec pharma produktin GmbH, Am Pharmapark, 06861 Dessau-Rosslau, Germany.



Manufactured byM/s. Mustafa Nevzat (MN), Ilac San. Ve Tic. A.S. Cobancesme Mah. Sanyi Cad. No.13 Yenibosna/Istanbul, Turkey.

Ocladra 2mg/ml injection (5ml vial)

Each vial contains:-Cladribine Hydrochloride……..10mg

(Treatment of Hairy cell Leukaemia)


Form 5A

Dy. No 361 Dated 29-04-2016Rs.50,000/-

As per PRC.

MHRA. Litak 2mg/ml Solution for injection 5ml/10mg by M/s Lipomed.

COPP issued on 22-01-2016. GMP compliant as per COPP.


140. M/s. Servier Research and Pharmaceuticals Pakaistan

VIACORAM 3.5/2.5 TabletEach tablet contains:-Perindopril

Form 5-ADy No. 37105-05-2016Rs.50,000/-

Original legalized COPP is not

Deferred for the submission of


Private Limited, 65 Main Boulevard Gulberg, Lahore. /M/s. Servier Deutschland GmbH Elsenheimerster 80687 Munich, Germany.

Arginine………..3.5mgAmlodipine…………………2.5mg(ACE inhibitors and calcium channel blockers)

New formulation02 years

provided followingValid legalized COPP/ GMP certificate & stability data as per conditions of Zone IV A.

141. M/s. Merixil Pharma,Office # 28, Second Floor, Rose Plaza, I-8 Markaz, Islamabad.

Manufactured by M/s. GP Pharma,Polígono Industrial Els Vinyets -Els Fogars, Sector 2. Carretera Comarcal C244, Km, 22 08777 Sant Quintí De Mediona Barcelona, Spain.

Lutrate 3month Depot (22.5mg) Injection

Each vial contains:Leuprorelin acetate powder for prolonged release suspension for injection….…22.5 mg

(Palliative treatmentof locally advanced & metastatic prostate cancer)

Manufacturer’s Specifications.

Shelf life : 36months

Form 5A

Dy. No. 387 Dated 04-05-2016 Rs.100,000/-

As Per SRO/Kit

The commercial kit includesi.Glass Vial of Leuprorelinii.Prefilled glass syringe 2ml containing solvent.iii.Polycarbonate HDPE Adaptor system with syringe with needle.

MHRA. Lutrate 22.5mg & 3.75mg powder and solvent for prolonged release suspension for injection.

(New molecule)



GMP issued dated 29-10-2014


142. M/s. Merixil Pharma,

Sterile Solvent For Lutrate Depot 3 month

Form 5A Dy. No 385

MHRA. Lutrate

COPP issued on

Approved as per


Office # 28, Second Floor, Rose Plaza, I-8 Markaz, Islamabad. Manufactured by M/s. GP Pharma,Polígon Industrial Els Vinyets -Els Fogars, Sector 2. Carretera Comarcal C244, Km, 22 08777 Sant Quintí De Mediona Barcelona, Spain.

Depot (22.5mg)

Each pre filled syringe 2ml contains:-

0.8% mannitol solution in water for injection.

For reconstitution purposeManufacturer’s Specifications

Shelf life: 36 months

Dated 04-05-2016 Rs.100,000/-

Free of Cost along with For Lutrate Depot 3 month Depot (22.5mg)

22.5mg & 3.75mg powder and solvent for prolonged release suspension for injection.

12-04-2016. (Same COPP for powder and solvent)

GMP issued dated 29-10-2014

import Policy for Finished Drugs

143. M/s. Merixil Pharma,Office # 28, Second Floor, Rose Plaza, I-8 Markaz, Islamabad. Manufactured by M/s. GP Pharma,Polígon Industrial Els Vinyets -Els Fogars, Sector 2. Carretera Comarcal C244, Km, 22 08777 Sant Quintí De Mediona Barcelona, Spain.

Lutrate 1month Depot (3.75mg) Injection

Each vial contains:Leuprorelin acetate powder for prolonged release suspension for injection….…3.75 mg

(Palliative treatmentof locally advanced & metastatic prostate cancer)


Shelf life : 36months

Form 5A

Dy. No 139 Datedm 04-05-2016 Rs.100,000/-

As per SRO/Kit

The commercial kit includesi.Glass Vial of Leuprorelinii.Prefilled glass syringe 2ml containing solvent.iii.Polycarbonate


Local. Lectrum 3.75mg by M/s Sandoz with solvent

COPP issued dated 12-04-2016. (Original Embassy attested)


Embassy attested GMP issued dated 29-10-2014



HDPE Adaptor system with syringe with needle..

144. M/s. Merixil Pharma,Office # 28, Second Floor, Rose Plaza, I-8 Markaz, Islamabad. /Manufactured by M/s. GP Pharma,Polígon Industrial Els Vinyets -Els Fogars, Sector 2. Carretera Comarcal C244, Km, 22 08777 Sant Quintí De Mediona Barcelona, Spain.

Sterile Solvent For Lutrate Depot 1 month Depot (3.75mg) Each pre filled syringe 2ml contains:0.8% mannitol solution in water for injection.

For reconstitution purpose



Form 5 A

Dy. No 386 dated 04-05-2016 Rs.100,000/-

Free of Cost


Local. Lectrum 3.75mg by M/s Sandoz with solvent

Same application applied for Lutrate Depot 3 month Depot (22.5mg)COPP issued dated 12-04-2016.


GMP issued dated 29-10-2014.

Rejected as already approved at S.No.142


M/s. United Biotech (P) Limited, Bagbani, Baddi, Nalagarh Road, District, Solan, India.

Amphotin 50mg Injection (Lyophilized)

Each vial contains:-Amphotericin B (Lyophilized)……….50mg

(Anti-fungal)


02 years

Form-5-A

Dy No.374 dated 04-05-2016 Rs.50,000/- & Rs.50,000 dated 24-06-2016.

As per SRO

MHRA. Fungizone 50mg powder for solution by M/s E.R Squibb.

Local. Medinet

Free sale issued dated 26-02-2016. COPP valid upto GMP valid upto 17-09-2017.

Defered as the product does not fall in the priority list. Moreover Anti-fungal drugs are not importable from India as per


Import Policy Order, 2016


Manufactured ByM/s. Alfa Wassermann S.p.A VIA Enrico Fermi, 1-65020 Alanno (PE), Italy Final Product release by M/s Biomendi, S.A. Poligono Industrial de Bernedo, s/n, Bernedo, 01118 Alava, Spain.

Zimta 4mg/5ml Conc. for solution for Injection Each vial contains:-Zoledronic Acid………….4mg

(Prevention of skeletal related events (e.g tumor induced hypercalcemia) in adult patients with advanced malignancies involving bone).


02 years

Form 5A

Dy. No 376 Dated 04-05-2016 Rs.50,000/- & 50,000 dated 24-06-2016.

MHRA. Zoledronic Acid 4mg/5ml Conc. for solution for Injection by M/s Intrapharm.

Local. Zometa by M/s Novartis



147. M/s. Servier Research and Pharmaceuticals Pakaistan Private Limited, 65 Main Boulevard Gulberg, Lahore.M/s. Les Laboratoirie Industrie, 905, route de Saran 45520 Gidy, France.

Triveram 20/5/5 TabletsEach film coated tablets contains:-Atorvastatin………………20mgPerindopril Arginine………5mgAmlodipine………………..5mg

(Statin/ACE Inhibitors/Calcium Antagonist)New formulation

02 years

Form 5-A

Dy. No.38205-05-2016Rs.50,000/-

Original legalized COPP / GMP is not provided.

Deferred for the submission of followinga.Approval status by reference regulatory authoritiesb.valid legalized COPP c.Stability data as per conditions of Zone IV A.


148. M/s. Servier Research and Pharmaceuticals Pakaistan Private Limited, 65 Main Boulevard Gulberg, Lahore./M/s. Les Laboratoirie Industrie, 905, route de Saran 45520 Gidy, France.


(Statin/ACE Inhibitors/Calcium Antagonist)

New formulation

02 years

Form 5-A

Dy. No.38505-05-2016Rs.50,000/-

Original legalized COPP is not provided.





New formulation

02 years

Form 5-A

Dy No.38405-05-2016Rs.50,000/-



150. M/s. Servier Research and Pharmaceuticals Pakaistan Private Limited, 65 Main Boulevard Gulberg, Lahore./

Triveram 20/10/10 tabletsEach film coated tablets contains:-Atorvastatin………………20mgPerindopril Arginine………10mgAmlodipine……………

Form 5-A

Dy No.38605-05-2016Rs.50,000/-


Deferred for the submission of followinga.Approval status by reference regulatory


M/s. Les Laboratoirie Industrie, 905, route de Saran 45520 Gidy, France.

…..10mg


New formulation

02 years

authoritiesb.valid legalized COPP c.Stability data as per conditions of Zone IV A.


Triveram 40/10/10 tabletsEach film coated tablets contains:-Atorvastatin………………40mgPerindopril Arginine………10mgAmlodipine………………..10mg


New formulation

02 years

Form 5-A

Dy No.38305-05-2016Rs.50,000/-



152. M/s. Servier Research and Pharmaceuticals Pakaistan Private Limited, 65 Main Boulevard Gulberg, Lahore./M/s. Servier Deutschland GmbH Elsenheimerster 80687 Munich, Germany.

Viacoram 7/5 TabletsEach tablets contains:-Perindopril Arginine………7mgAmlodipine………………..5mg

(ACE Inhibitors/Calcium channel blockers, ATC)New formulation

02 years

Form 5A

Dy No.38105-05-2016Rs.50,000/-

Original Legalized COPP is not provided



153. M/s. Atco Laboratories Limited, B-18, S.I.T.E. Karachi.

Manufactured byM/s. Fresenius Kabi Oncolony Limited, Village KIshanpura, P.O. Guru Majra, Tehsil Nalagarh, Distt. Solan (H.P) 174 101, India.

Bendamustine Hydochloride Injection 100mg

Each vial contains:-Bendamustine Hydochloride………..100mgMannitol Ph. Eur……120mg



24 months

Form 5A

Dy. No 308 Dated 06-05-2016 Rs.50,000/-

Rs.25000/vial

FDA. Bendamustine powder for infusion by M/s Hospira.

COPP valid upto 03-01-2015.GMP certificate not provided. Stability data as per conditions of Zone IV-B attached.

Deferred for the submission of GMP status of the firm as CoPP does not reflect GMP status.


Floor Rose 1, Plaza I-8 Markaz Islamabad.Product License HolderM/s Farmoz-Sociedade Tecnico Medicinal’ S.A. Rua da Tapada Grande, 2, Abrunheira 2710-089 Sintra, Portugal.Manufactured by.M/s Laboratorios Vitoria, S.A. (Fab) Rua Elias Garcia, 28-

Amtron 8 mg (2mg/ml) solution for injection

Each 8mg/4ml ampoule contains:Ondansetron ………..8mg/4ml

(Antimetics used in cancer induced vomiting)

Manufacturer’s Specifications03years

Form 5A Dy. No 1039 dated 26.09.2016 Rs.100000/-

As per SRO/ pack of 5

MHRA.Ondansetron 2mg/ml by M/s Hameln

Local. Zofran by M/s GSK

COPP issued on 01-04-2014 by Portagal. GMP compliant as per COPP.

Deferred for clarification of date of submission of application


Venda Nova 2700-327 Amadora, Portugal & M/s. Atlantic Pharma, Producoes Farmacueticals, SA Rua da Tapand, n 2 Abruheeira Sintra, 2710-089, Portugal


M/s. North China Co. Ltd, No. 115 Hainan Road, Economic & Techonological Development Zone, Shijiazhuang, China

Cyclocure 25mg Capsule

Each soft gel capsule contains:-Cyclosporin………….25mg

(Immunosuprent)

(Manufacturer’s Specs)

24 months

Form 5A


Rs.1940 /50’s

MHRA. Neoral Soft Gelatin Capsule 25mg by M/s Novartis

COPP issued dated 03-08-2015 vide no. 20150529 valid upto 2 years.GMP valid upto 26-06-2017 vide no. HF20120014.Stability data as per conditions of Zone IVA attached.

Deferred as firm has not submitted real time stability data upto assigned shelf life, of Zone IV A.


M/s. North China Co. Ltd, No. 115 Hainan

Cyclocure 50mg Capsule

Each soft gel capsule contains:-Cyclosporin………….50mg

(Immunosuprent)

(Manufacturer’s Specs)

Form 5A


Rs.3881 /50’s

COPP issued dated 03-08-2015 vide no. 20150527 valid upto 2 years.GMP valid

Deferred as firm has not submitted real time stability data upto assigned shelf life, of Zone IV A.


Road, Economic & Techonological Development Zone, Shijiazhuang, China

24 monthsupto 26-06-2017 vide no. HF20120014.Stability data as per conditions of Zone IVA attached



Manufactured by M/s. Glaxo Operations UK Ltd, Priory Street, Ware, Hertfordshire SG12 ODJ, United Kingdom.Site Responsible for Primary & Secondary PackagingM/s Glaxo

Triumeq Tablet

Each film coated tablets contains:-Dolutegravir as sodium……50mgAbacavir as sulfate…….600mgLamivudine…….300mg

Anti-HIV, new molecule

36 months

Form 5A

Dy No. 404 R&I dated 24-05-2016 Rs.50,000/-


COPP issued dated10-02-2016 vide No. 01/16/95860 by EMA.GMP compliant as per COPP.

Approved


Wellcome S.A., Avenida Extremadura 3, Aranda de Duero, Burgos, 09400, Spain.

158. M/s Johnson & Johnson Pakistan Pvt Ltd, KarachiName of Distributor M/s Ethicon, LLC 475 C Street Los Frailes Industrial Park Guaynabo, PR, USA 00969Name of Manufacturer:-M/s Surgical Specialities Puerto Rico, Inc; Angiotech PR Inc. Doing business as Angiotech Puerto Rico, Inc; Road 459 KM 0.6 Montana Industrial Park Aguadilla, PR, USA 00603.

Stratafix Knotless tissue control device

Each unit of device contains:-Polydioxanone/PGA-PCL/Polypropylene

(Class III Medical device)New Molecule

Form 5A

Dy No. 679 dated 11-04-2014 Rs.50,000.

Not mentioned

Certificate to foreign Government No. 1171-6-2013 issued dated 14-06-2013 valid upto 2 years.Medical Device

Deferred for the expert opinion from Expert Committee for Medical Devices (ECMD).

Product Code Product DescriptionSXMD1B100 PS-1 2-0 PGA-PCL 30CMSXMD1B101 PS-2 3-0 PDO 45CMSXMD1B102 PSL 0 PGA-PCL 60CMSXMD1B103 PS-2 2-0 PGA-PCL 30CMSXMD1B104 PS-2 2-0 PGA-PCL 60CMSXMD1B105 PS-2 3-0 PGA-PCL 30CMSXMD1B106 PS-2 3-0 PGA-PCL 60CMSXMD1B402 RB-1 3-0 PGA-PCL 20CMSXMD1B403 RB-1 2-0 PGA-PCL 20CM


SXMD1B404 RB-1 0 PGA-PCL 20CMSXMD1B405 SH 2-0 PGA-PCL 20CMSXMD1B406 SH 0 PGA-PCL 20CMSXMD1B407 CT-1 2-0 PGA-PCL 45CMSXMD1B408 CT-1 0 PGA-PCL 45CMSXMD1B409 CT-1 1 PGA-PCL 45CMSXMD2B150 2PS-l 3-0 UNO MONODERM 30X30SXMD2B400 2MH -0- UNDYED MONODERM 14X14SXMD2B401 2MH -0- UNDYED MONODERM 36X36SXMD2B402 2R8-1 2-0 U MND 16X1613MM LORSXMD2B403 2RB-l 3-0 U MND 16X1613MM LORSXMD2B404 2FS-2 2-0 UNDYED MONODERM 7X7SXMD2B405 2FS-2 3-0 UNDYED MONODERM 7X7SXMD2B406 2FS-2 2-0 UNDYD MONODERM 14X14SXMD2B407 2FS-2 3-0 UNDYD MONODERM 14X14SXMD2B408 2FS-2 2-0 UNDYD MONODERM 30X30SXMD2B409 2FS-2 3-0 UNDYD MONODERM 30X30SXMD2B410 2FS-l 2-0 UND MONODERM 30X30SXMD2B411 2FS 2-0 UNDYD MONODERM 14X14SXMD2B412 2FS 2-0 UNDYD MONODERM 30X30SXMD2B413 2FS 3-0 UNDYD MONODERM 30X30SXMD2B413 2FS 3-0 UNDYD MONODERM 30X30SXMD2B414 2CP-2 -0- UNDYD MONODERM 14X14SXPD1B100 PS-2 2-0 PDO 45CMSXPD1B101 PS-2 3-0 PDO 45CMSXPD1B400 CT-1 0 PDO 20CMSXPD1B401 CT-1 0 PDO 30CMSXPD2B200 20S-6 #2 PDO 24X24SXPD2B201 20S-6 #2 POD 30 X 30SXPD2B202 20S-8 #2 PDO 36 X 36SXPD2B400 2MO-4 #2 PDO 36 X 36SXPD2B401 2CT-1 -2- PDO 14X 14SXPD2B402 2CT-1 #2 PD024X24SXPD2B403 2CT -1 #2 PDO 30 X 30SXPD2B404 2CT-3-1- PDO 14X14 13MM LDRSXPD2B405 2CTX #2 PDO 36 X 36SXPD2B406 2MH -0- PDO 7X7 13MM LEADERSXPD2B407 2MH -0- PDO 14X1413MMLEADERSXPD2B409 2MH-1-PDO 14X14SXPD2B408 2MH -0- PDO 24 X 24SXPD2B410 2MH #1 PDO 24 X 24SXPD2B411 2MH #1 PDO 30 X 30SXPD2B412 2MH -0- PDO 36 X 36


SXPD2B413 2SH-0- PDO 10 X 10 13MM LEADERSXPD2B414 2SH -0- PDO 14 X 14 13MMLEADERSXPD2B415 2CP-2 #I PDO 24X24SXPD2B416 2CP-2 #2 PDO 24 X 24SXPD2B417 2FS 2-0 PDO 14X14SXPD2B418 2FS -0- PDO 14 X 14SXPD2B419 2FS 2-0 PDO 24 X 24SXPD2B420 2FS -0- PDO 24 X 24SXPD2B421 2FS-2 4-0 PDO 7 X 7SXPD2B422 2FS-2 3-0 PDO 7X7SXPD2B423 2FS-2 3-0 PDO 14 X 14SXPD2B424 2V-26 3-0 PDO 24 X 24SXPD2B425 2V-26 3-0 PDO 14X14SXPD2B426 2V-4 3-0 PDO 24X24SXPL1B400 DE12 0 PPN 30CMSXPL2B400 2CT-1 -2- CL PPN 24X24SXPL2B401 2CT-3 -1- CL PPN 14X1413MM LDRSXPP1A100 STRATAFIX SYMM PDS PLUS 45cm; PS-1; 3-0; PlasticsSXPP1A101 STRATAFIX SYMM PDS PLUS 45cm; PS-2; 3-0; PlasticsSXPP1A200 STRATAFIX SYMM PDS PLUS 45cm; OS-6; 0; OrthoSXPP1A201 STRATAFIX SYMM PDS PLUS 45cm; OS-6; 1; OrthoSXPP1A300 STRATAFIX SYMM PDS PLUS 45cm; CTXB; 1; EthiguardSXPP1A301 STRATAFIX SYMM PDS PLUS 45cm; CTB-1; 1; EthiguardSXPP1A302 STRATAFIX SYMM PDS PLUS 45cm; CTXB; 0; EthiguardSXPP1A400 STRATAFIX SYMM PDS PLUS 45cm; CTX; 1SXPP1A401 STRATAFIX SYMM PDS PLUS 45cm; CT-1; 0SXPP1A402 STRATAFIX SYMM PDS PLUS 45cm; CTX; 0SXPP1A403 STRATAFIX SYMM PDS PLUS 45cm; CT-1; 2-0SXPP1A404 STRATAFIX SYMM PDS PLUS 45cm; CT-1; 1SXPP1A405 STRATAFIX SYMM PDS PLUS 45cm; CT; 1SXPP1A406 STRATAFIX SYMM PDS PLUS 45cm; CT; 0SXPP1A407 STRATAFIX SYMM PDS PLUS 45cm; CT-2; 0SXPP1A408 STRATAFIX SYMM PDS PLUS 45cm; CT-2; 2-0SXPP1A409 STRATAFIX SYMM PDS PLUS 45cm; SH; 2-0SXPP1A410 STRATAFIX SYMM PDS PLUS 45cm; SH; 3-0SXMP1B101 MONOCRYL PLUS 30CM M -2 USP 3/0 SGLE ARMED PS-1SXMP1B102 MONOCRYL PLUS 45CM M -2 USP 3/0 SGLE ARMED PS-1SXMP1B103 MONOCRYL PLUS 60CM M -2 USP 3/0 SGLE ARMED PS-1SXMP1B104 MONOCRYL PLUS70CM M -2 USP 3/0 SGLE ARMED PS-1SXMP1B105 MONOCRYL PLUS15 CM M -2 USP 3/0 SGLE ARMED PS-2SXMP1B106 MONOCRYL PLUS 30CM M -2 USP 3/0 SGLE ARMED PS-2SXMP1B107 MONOCRYL PLUS 45CM M -2 USP 3/0 SGLE ARMED PS-2SXMP1B108 MONOCRYL PLUS 60CM M -2 USP 3/0 SGLE ARMED PS-2


SXMP1B109 MONOCRYL PLUS 70CM M -2 USP 3/0 SGLE ARMED PS-2SXMP1B110 MONOCRYL PLUS 30CM M -2 USP 3/0 SGLE ARMED PSSXMP1B111 MONOCRYL PLUS 45CM M -2 USP 3/0 SGLE ARMED PSSXMP1B113 MONOCRYL PLUS 70CM M -2 USP 3/0 SGLE ARMED PSSXMP1B114 MONOCRYL PLUS 30CM M -1.5 USP 4/0 SGLE ARMED PS-1SXMP1B115 MONOCRYL PLUS 45CM M -1.5USP 4/0 SGLE ARMED PS- 1SXMP1B116 MONOCRYL PLUS 70CM M -1.5 USP 4/0 SGLE ARMED PS- 1SXMP1B117 MONOCRYL PLUS 30CM M -1.5 USP 4/0 SGLE ARMED PS-2SXMP1B118 MONOCRYL PLUS 45CM M -1.5USP 4/0 SGLE ARMED PS- 2SXMP1B119 MONOCRYL PLUS 70CM M -1.5 USP 4/0 SGLE ARMED PS- 2SXMP1B120 MONOCRYL PLUS 45CM M1.5 USP 4/0 SGLE ARMED PS-4SXMP1B408 MONOCRYL PLUS 15CM M3 USP 2/0 SGLE ARMED SHSXMP1B409 MONOCRYL PLUS 20CM M3 USP 2/0 SGLE ARMED SHSXMP1B410 MONOCRYL PLUS 30CM M3 USP 2/0 SGLE ARMED SHSXMP1B411 MONOCRYL PLUS 15CM M3 USP 2/0 SGLE ARMED CT-1SXMP1B412 MONOCRYL PLUS 30 CM M3 USP 2/0 SGLE ARMED CT-1SXMP1B413 MONOCRYL PLUS 45 CM M3 USP 2/0 SGLE ARMED CT-1SXMP1B414 MONOCRYL PLUS 70 CM M3 USP 2/0 SGLE ARMED CT-1SXMP1B415 MONOCRYL PLUS 15CM M3 USP 2/0 SGLE ARMED CT-2SXMP1B416 MONOCRYL PLUS 30 CM M3 USP 2/0 SGLE ARMED CT-2SXMP1B417 MONOCRYL PLUS 45 CM M3 USP 2/0 SGLE ARMED CT-2SXMP1B419 MONOCRYL PLUS 70 CM M3 USP 2/0 SGLE ARMED CT-2SXMP1B420 MONOCRYL PLUS 30 CM M3 USP 2/0 SGLE ARMED PSLSXMP1B421 MONOCRYL PLUS 70 CM M3 USP 2/0 SGLE ARMED PSLSXMP1B424 MONOCRYL PLUS 15CM M2 USP3/0 SGLE ARMED RB-1SXMP1B425 MONOCRYL PLUS 30CM M2 USP3/0 SGLE ARMED RB-1SXMP1B426 MONOCRYL PLUS 70CM M2 USP3/0 SGLE ARMED RB-1SXMP1B427 MONOCRYL PLUS 20CM M2 USP3/0 SGLE ARMED SHSXMP1B428 MONOCRYL PLUS 70CM M2 USP3/0 SGLE ARMED SHSXMP1B429 MONOCRYL PLUS 45CM M2 USP3/0 SGLE ARMED CT-1SXMP1B430 MONOCRYL PLUS 15CM M2 USP3/0 SGLE ARMED BBSXMP1B431 MONOCRYL PLUS 30CM M2 USP3/0 SGLE ARMED BBSXMP1B432 MONOCRYL PLUS 15CM M2 USP3/0 SGLE ARMED ST-4SXMP1B433 MONOCRYL PLUS 30CM M2 USP3/0 SGLE ARMED ST-4SXMP1B434 MONOCRYL PLUS 15CM M1.5 USP4/0 SGLE ARMED RB-1SXMP1B435 MONOCRYL PLUS 30CM M1.5 USP4/0 SGLE ARMED RB-1SXMP1B436 MONOCRYL PLUS 70CM M1.5 USP4/0 SGLE ARMED RB-1SXMP1B437 MONOCRYL PLUS 70CM M1.5 USP4/0 SGLE ARMED SHSXPP1B101 PDS PLUS VIO 45CM M3 UPS/2-0 SGLE ARMED FSSXPP1B102 PDS PLUS VIO 70CM M3UPS/2-0 SGLE ARMED FSSXPP1B103 PDS PLUS VIO 15CM M2 UPS/3-0 SGLE ARMED PS-2SXPP1B104 PDS PLUS VIO 30CM M2 UPS/3-0 SGL ARMED PS-2SXPP1B105 PDS PLUS VIO 45CM M2 UPS/3-0 SGLE ARMED PS-2


SXPP1B106 PDS PLUS VIO 70CM M2 UPS/3-0 SGLE ARMED PS-2SXPP1B107 PDS PLUS VIO 30CM M2 UPS/3-0 SGLE ARMED PS-2SXPP1B108 PDS PLUS VIO 45CM M2 UPS/3-0 SGLE ARMED PS-2SXPP1B109 PDS PLUS VIO 70 CM M2 UPS/3-0 SGLE ARMED PSSXPP1B110 PDS PLUS VIO 70 CM M2 UPS/3-0 SGLE ARMED PS-1SXPP1B111 PDS PLUS VIO 15 CM M2 UPS/4-0 SGLE ARMED PS-2SXPP1B112 PDS PLUS VIO 30CM M2 UPS/4-0 SGLE ARMED PS-2SXPP1B113 PDS PLUS VIO 45CM M2 UPS/4-0 SGLE ARMED PS-2SXPP1B114 PDS PLUS VIO 70CM M1.5 UPS/4-0 SGLE ARMED PS-2SXPP1B115 PDS PLUS VIO 30CM M2 UPS/4-0 SGLE ARMED PS-1SXPP1B116 PDS PLUS VIO 45CM M2 UPS/4-0 SGLE ARMED PS-1SXPP1B117 PDS PLUS VIO60CM M2 UPS/4-0 SGLE ARMED PS-1SXPP1B118 PDS PLUS VIO 45CM M2 UPS/4-0 SGLE ARMED PSSXPP1B201 PDS PLUS VIO 45CM M4 UPS/1 SGLE ARMED OS-6SXPP1B202 PDS PLUS VIO 45CM M3.5 UPS/0 SGLE ARMED CP-2SXPP1B203 PDS PLUS VIO 70CM M4 UPS/1 SGLE ARMED OS-6SXPP1B204 PDS PLUS VIO 70CM M4 UPS/1 SGLE ARMED OS-8SXPP1B205 PDS PLUS VIO 70CM M4 UPS/1 SGLE ARMED MO-4SXPP1B401 PDS PLUS VIO 70CM M4 UPS/1 SGLE ARMED CT XSXPP1B402 PDS PLUS VIO 90CM M4 UPS/1 SGLE ARMED CTXSXPP1B403 PDS PLUS VIO 45CM M4 UPS/1 SGLE ARMED CP-2SXPP1B404 PDS PLUS VIO 20CM M3.5 UPS/0 SGLE ARMED V-34SXPP1B405 PDS PLUS VIO 30CM M3.5 UPS/0 SGLE ARMED CT-2SXPP1B406 PDS PLUS VIO 15CM M3.5 UPS/0 SGLE ARMED CT-1SXPP1B407 PDS PLUS VIO 45CM M3.5 UPS/0 SGLE ARMEDCT-1SXPP1B408 PDS PLUS VIO 70CM M3.5 UPS/0 SGLE ARMED CT-1SXPP1B409 PDS PLUS VIO 15CM M3 UPS/2-0 SGLE ARMED CT-1SXPP1B410 PDS PLUS VIO 30CM M3 UPS/2-0 SGLE ARMED CT-1SXPP1B411 PDS PLUS VIO 45CM M3 UPS/2-0 SGLE ARMED CT-1SXPP1B412 PDS PLUS VIO 70CM M3 UPS/2-0 SGLE ARMED CT-1SXPP1B413 PDS PLUS VIO 15CM M3UPS/2-0 SGLE ARMED CT-2SXPP1B414 PDS PLUS VIO 70CM M3 UPS/2-0 SGLE ARMED CT-2SXPP1B415 PDS PLUS VIO 15CM M3 UPS/2-0 SGLE ARMED SHSXPP1B416 PDS PLUS VIO 30CM M3 UPS/2-0 SGLE ARMED SHSXPP1B417 PDS PLUS VIO 70CM M3 UPS/2-0 SGLE ARMED SHSXPP1B418 PDS PLUS VIO 20CM M3 UPS/2-0 SGLE ARMED V-7SXPP1B419 PDS PLUS VIO 30CM M3 UPS/2-0 SGLE ARMED UR-6SXPP1B420 PDS PLUS VIO 15CM M2 UPS/3-0 SGLE ARMED SHSXPP1B421 PDS PLUS VIO 70CM M2 UPS/3-0 SGLE ARMED SHSXPP1B422 PDS PLUS VIO 15CM M2 UPS/3-0 SGLE ARMED RB-1SXPP1B423 PDS PLUS VIO 70CM M2 UPS/3-0 SGLE ARMED RB-1SXPP1B424 PDS PLUS VIO 15CM M2 UPS/3-0 SGLE ARMED ST-4SXPP1B425 PDS PLUS VIO 70CM M2 UPS/3-0 SGLE ARMED CT-2


SXPP1B426 PDS PLUS VIO 70CM M1.5UPS/4-0 SGLE ARMED SHSXPP1B427 PDS PLUS VIO 15CM M1.5UPS/4-0 SGLE ARMED RB-1SXPP1B428 PDS PLUS VIO 30CM M1.5 UPS/4-0 SGLE ARMED RB-1SXPP1B429 PDS PLUS VIO 30CM M4UPS/1 SGLE ARMED CT-1SXPP1B430 PDS PLUS VIO 45CM M4 UPS/1 SGLE ARMED CT-1SXPP1B431 PDS PLUS VIO 70CM M4UPS/1 SGLE ARMED CT-1SXPP1B450 PDS PLUS VIO 30CM M3.5 UPS/0 SGLE ARMED CT-1SXPP1B451 PDS PLUS VIO 70 CM M3.5UPS/0 SGLE ARMED M05SXPP1B452 PDS PLUS VIO 30CM M3.5 UPS/0 SGLE ARMED EN-S

Muhammad Ansar Evaluator-IReplies of the import cases deferred in 259th meeting of the Registration Board.

159. M/s Merixil Pharma, Office #28, 2nd floor Rose Plaza, I-8, Markaz, Islamabad.

Manufactured byM/s Eris Pharmaceutical (Australia) Pty Ltd, 6 Eastren Road South Melbourne VIC 3205, Australia.(230)

Tablet Azastrole 1mg

Each film coated tablet contains:-Anastrozole…….1mg



Form 5A

18-04-2014 vide diary No. 314 R&I Rs.100,000.

As per SRO/3x10’s

TGA. Azastrole 1mg

Arimedex 1mg by M/s ICI

The firm has submitted

Legalized Free sale issued dated 30-12-2013.Stability data as per conditions of Zone IV-ALegalized GMP certificate issued dated 25-02-2013.

Now the firm has submitted that in registration dossier license to manufacture therapeutic goods (Legalized), the anti-neoplastic agents tablet section is mentioned in its attachments furthermore the firm has replied that the product is TGA approved brand and also same

Approved as per import Policy for Finished Drugs. Product is approved by TGA which is a reference regulatory authority.


is available on the site of TGA.

160. M/s Merixil Pharma, Office #28, 2nd floor Rose Plaza, I-8, Markaz, Islamabad.(231)Manufactured byM/s Eris Pharmaceutical (Australia) Pty Ltd, 6 Eastren Road South Melbourne VIC 3205, Australia.(231)

Tablet Gynotril 2.5mg



USP Specifications

Form 5A


As per SRO/3x10’s

TGA. Gynotril 2.5mg

Femara 2.5mg by M/s Novartis

The firm has submitted

Legalized Free sale issued dated 30-12-2013.Stability data as per conditions of Zone IV-ALegalized GMP certificate issued dated 25-02-2013.

Now the firm has submitted that in registration dossier license to manufacture therapeutic goods (Legalized), the anti-neoplastic agents tablet section is mentioned in its attachments furthermore the firm has replied that the product is TGA approved brand and also same is available on the site of TGA.

Approved as per import Policy for Finished Drugs. Product is approved by TGA which is a reference regulatory authority.

161. M/s Merixil Pharma, Office #28, 2nd floor Rose Plaza, I-8, Markaz, Islamabad.

Tablet Bicalox 50mg

Each film coated tablet contains:-Bicalutamide…….50mg

Adjuant to

Form 5A


TGA. Bicalox 50mg

Casodex 50mg by M/s ICI

The firm has submitted:-

Legalized Free sale issued dated 30-12-2013.Stability

Now the firm has submitted that in registration dossier license to manufacture therapeutic

Approved as per import Policy for Finished Drugs. Product is approved by TGA which is a


Manufactured byM/s Eris Pharmaceutical (Australia) Pty Ltd, 6 Eastren Road South Melbourne VIC 3205, Australia.(232)

radial prostectomy or radio-therapy in patients with locally advanced prostate cancer

USP Specifications

As per SRO/

data as per conditions of Zone IV-ALegalized GMP certificate issued dated 25-02-2013.

goods (Legalized), the anti-neoplastic agents tablet section is mentioned in its attachments furthermore the firm has replied that the product is TGA approved brand and also same is available on the site of TGA.

reference regulatory authority.

162. M/s Zam Zam Corporation, Suit No. 205-206, Beaumont Plaza, Beaumont Road, KarachiManufactured byM/s LEO Pharma A/S Industriparken 55 DK-2750 Ballerup, Denmark.(189)

Daivobet Gel.

Each gm contains:-Calcipotriol……..…50mcgBetamethasone Dipropionate……....0.5mg

Topical Vitamin D analogue & Steroid.


Form 5A

26-12-2013 vide diary No. 469 R&I Rs.50,000

Rs.1600/15gm tube

Denmark Daivobet Gel by M/s LEO.

The firm has submitted:-

Free sales certificate 10-12-2012(legalized photocopy).GMP issued dated 01-06-2010.

Now the firm has replied the product is Denmark approved which is reference country.

Approved as per import Policy for Finished Drugs.

163. M/s Letroze 2.5mg Form 5A TGA. The firm Now the Approved


Amgomed, office No. 05, 1st

floor, Rose 1 Plaza, I-8, Markaz, Islamabad.From Manufactured ByM/s West Pharma, Producoes de Especialiaes Farmaceuticas, SA Rua Joao De Deus, n. 11, Amadora, 2700-486, Portugal.

(227)

tablet



USP Specifications


As per SRO/30 tablets

Gynotril 2.5mg

Femara 2.5mg by M/s Novartis

has submitted

COPP Legalized issued dated 19-11-2013.Firm is GMP compliant as per COPP Legalized issued dated 19-11-2013.Stability data as per conditions of Zone IV-A.

firm has submitted the GMP legalized which shows the details of sections i.e firm has non sterile antineoplastic tablet section.

as per import Policy for Finished Drugs.

164. M/s Revive Healthcare, Office 503, 5th Floor, 6 Main Gulberg, Jail Road, Lahore, Pakistan.

Manufactured byM/s United Biotech (P) Ltd.

Vesna Injection 200mg

Each 1ml contains:-Sodium-2-Sulphanylethanesulphonate BP……100mg

Antineoplastic Agent

USP Specifications

Form 5A


As per SRO/2ml ampoule

MHRA. Mesna 200mg/2ml by M/s Claris Lifesciences UK.

The firm has submitted Legalized COPP valid upto 10-09-2013.Stability data as per conditions of Zone IV-A.Legalized GMP dated 13.09.2010.

Now the firm has submitted the COPP for the Vesna valid upto 10-05-2017 which shows that the product is available in alone.



FC/B-1 (Extn.) Mohan Cooperative Industrial Estate, Mathura Road, New Delhi-110044, India.(129)

The following product of M/s. Revive Health Care, Lahore was discussed in the 243rd meeting of the board and was approved.

It is submitted that there is a typographical mistake in the formulation the Sodium 2-Sulphanylethansulphonate 100mg were written inadvertently.

M/s. Revive Health Care, Lahore. /M/s. United Biotech (P) Limited, Bagbani, Baddi, Nalagarh Road, District, Solan, India.

Ifomid-M 1gm Injection Each vial contains:-Ifosfamide…………….1gmSodium 2-Sulphanylethansulphonate BP……………..……100mg(ATC Class: L01AA06).

As per SRO/PRC

02 years Approved as per import Policy for Finished Drugs.

The correct formulation is as under

165. M/s. Revive Health Care, Lahore. /M/s. United Biotech (P) Limited, Bagbani, Baddi, Nalagarh Road, District, Solan, India.

Ifomid-M 1gm Injection Each vial contains:-Ifosfamide…………….1gm

(ATC Class: L01AA06).

As per SRO/PRC

02 years valid COPP valid upto

10-05-2017



Muhammad Ansar Evaluator-I

Replies of product deferred in 254th meeting of the Board.

166. ImporterM/s Efroz Chemical Industries (Pvt) Limited, 12-C Block 6, P.E.C.H.S. off Shahrah-e- Faisal, KarachiManufacturerM/s Dae Hwa Pharmaceuticals Co., Ltd495- Hanu-ro-, Hoenseong-eup, Hoenseong, Gangwon-do, Republic of Korea.

KETOFAST Cataplasma

Each sheet (9x13cm2, 11.7gm) contains:Ketoprofen…..25.07mg

NSAID

Manufacturer

Form-5A

Dy No : 468 dated 26-01-1115000/- dated 26-01-1185000/- dated 19-02-14

Rs. 500/- Per 6’s Sheets

International availibility not confirmed.

Kefentech Plaster by M/s Matrix Reg #047624.

Deferred for:Evidence of approval of same dosage form, generic and strength in reference drug agency.Confirmation of address of the manufacturer of the applied product as the address mentioned on Form-5A & GMP is different from the address mentioned in the COPP. Moreover, address of manufacturer on sole agency agreement is different from address of above mentioned documents.Clarfication that applied drug is generic product hence

Legalized GMP issued dated 28-01-2016 by Korea.Legalized COPP issued dated 26-05-2016 by Korea.Product is in free sale in Korea.Local Kefentech by M/s Matrix.

Deferred for the confirmation of approval status by reference regulatory authorities


clinical data and clinical justification is not required.Stability data as per WHO/ICH Zone-IV A.

Muhammad Ansar Evaluator-IRoutine Import Applications

Veterinary Import applications Routine

Decision

167. M/s. Ghazi Brothers, Karachi-75350. /M/s. Pharmacia & Upjohn Company A Division of Pfizer Inc. Kalamazoo, Michigan, U.S.A.

362

Spectramast DC Suspension Each 10ml Plastet Disposable Syringe contains:-Ceftiofur Equivalents (as the hydrochloride sale)…500mg

(Antibiotic).

Manufacturer’s specifications

Form 5-A


Decontrolled/10ml

FDA. Ceftifur 500mg by M/s M/s. Pharmacia & Upjohn

COPP issued by US FDA dated 20-03-2013.GMP compliant as per COPP.


168. M/s. Ghazai Brothers, Karachi-75350. /M/s. Pharmacia & Upjohn Company A Division of Pfizer Inc. Kalamazoo, Michigan, U.S.A.

363

Spectramast LC Suspension Each 10ml Plastet Disposable Syringe contains:-Ceftiofur Equivalents to Ceftiofur …125mg

(Antibiotic).

Manufacturer’s specifications

Form 5-A


Decontrolled/10ml

FDA. Ceftifur 250mg by M/s M/s. Pharmacia & Upjohn

COPP issued by US FDA dated 09-10-2015.GMP compliant as per COPP.



24 Months169. M/s. Ghazi

Brothers, Ghazi House, D-35. K.D.A. Scheme No.1, Miran Muhammad Shah Road, Karachi-75350

Product License Holder:- M/s. Agrovet Market S.A., Av. Canada 3792 San Luis, Lima, Peru.Manufacturer Under Product License Holder:-M/s. Pharmadix Corp. S.A.C. Urbanizacion La Aurora-Ate Lima 3-Peru.

426

ADEFORTEX Injectable Solution

Each mL contains:-Vitamin A (Palmitic ester of Vitamin A)……………500,000 I.UVitamin D3 (Pure Cholecalciferol)…..75,000 I.UVitamin E (Alpha-Tocopherol Acetate)……………..50mg

Vitamin Supplement.


03 years

Form 5-A

Dy. No. 211 R&I Rs. 50,000/- dated 19-03-2014 & Rs. 50,000 dated 30-07-2016 dy No. 822.

Decontrolled/100ml

Local. Duravit AD3E Injection by M/s Mylab.

Free sale issued dated 19-12-2012.GMP issued dated 06-02-2013.


170. M/s. Ghazi Brothers, Karachi.

M/s. Bayer New Zealand Limited,Hillcrest, Auckland, New Zealand.

410

Ovuprost Aqueous Injectable Solution

Each mL contains:-Cloprostenol (as Sodium)…..250ug

Gynaecologicals-Oxytocics.

B.P Specifications

Form 5-A

Rs. 50,000/- vide Dy. No. 53 dated 6-01-2014 & Rs.50,000 dated 30-07-2016 dy No.820.

Decontrolled/

Delzamazin by M/s Prix

Free sales certificate issued dated 11-10-2012.GMP issued dated 15-05-2013.


171. M/s. Ghazi Brothers, Ghazi House,

Ectomethrn 200 Emulsion liquid.

Form 5-A

Rs. 50,000/- Local.

Free sales certificate issued

Approved as per import


D-35. K.D.A. Scheme No.1, Miran Muhammad Shah Road, Karachi-75350

Product License Holder:- M/s. Agrovet Market S.A., San Luis, Lima, Peru.

Manufacturer Under Product License Holder:-M/s. Pharmadix Corp. S.A.C. Urbanizacion La Aurora-Ate Lima 3-Peru.

429

Each mL emulsifiable concentrate contains:-Cypermethrin…...200mg

Ectoparasiticide.


vide Dy. No. 212 dated 19-03-2014 & Rs 50,000 dated 30-07-2016 Dy No.821.

Decontrolled/ 10ml, 20ml, 50ml, 100ml, 250ml, 500ml & 1 litre.

Cypothern 200 Solution by star

dated 29-10-2013.GMP compliant issued dated29-10-2013.

Policy for Finished Drugs.

172. M/s. Ghazi Brothers, Ghazi House, D-35. K.D.A. Scheme No.1, Miran Muhammad Shah Road, Karachi

Product License Holder.M/s Cevasa S.A 23rd Street N 293 Pilar Industrial Park, Pilar State of Buenos Aires, Argentina.Manufactured by.

Cevasametrina 20 Emulsion solution.

Each 100mL emulsifiable concentrate contains:-Cypermethrin…...20g

Ectoparasiticide.


Form 5-A

Rs. 50,000/- vide Dy. No. 209 dated 19-03-2014 & Rs.50,000 dated 30-07-2016 dy No. 823.

Decontrolled/ 20ml, 50ml, 100ml, 500ml & 1 litre.

Local. Cypothrin 20 by Star labs

Free sales certificate issued dated 26-09-2012.GMP compliant as per FSC dated 26-09-2012.



Midori S.R.L, Stephenson 3294, Tortuguitas, Buenos Aires, Argentina

425

Human Import Applications Routine

173. M/s Novartis Pharma (Pakistan), Limited 15 West Wharf, Karachi

Manufactured byM/s Sandoz Private Ltd. MIDC Plot No. 8-A/2 & 8-B TTC Industrial area Kalwe Block Village Dighe Navi , Mumbai, India.195

Micocept Capsule

Each Capsule Contains:Mycophenolate Mofetil………...250mg

(Immunosuppressant)


Form 5-A

Dairy No. 1263dated 21-12-2012Rs.100000/-

Rs.2925/- /50tabsRs.58.50/Tab

COPP issued dated 17-12-2014 by TGA.GMP compliant as per CoPP.CoPP valid upto 20-03-2015 by India.GMP valid upto 20-03-2015.

Approved as per Import policy for Finished Drugs and compliance of Import Policy Order, 2016

174. M/s Novartis Pharma (Pakistan), Limited 15 West Wharf, Karachi

M/s Sandoz Private Ltd. MIDC Plot No. 8-A/2 & 8-B TTC Industrial area Kalwe Block Village Dighe Navi ,

Micocept Film coated tablets

Each film coated tablet Contains:Mycophenolate Mofetil……..500mg

(Immunosuppressant)


Form 5-A

Dairy No. 1264dated 21-12-2012Rs.100000/-

Rs.6000/- /50tabsRs.120/Tab

COPP issued dated 17-12-2014 by TGA.GMP compliant as per CoPP.CoPP valid upto 20-03-2015 by India.GMP


Mumbai, India.

94

valid upto 20-03-2015.

175. M/s Umar Pharma Pvt Ltd, C 5/6, Auqaf Plaza Dabgari Garden, Peshwar. Manufactured byM/s Genepharma S.A, 18th Km, Marathonosavenue-15351, Pallini-Greece.

131

Femaplex 2.5mg tablet

Each film coated tablet contains:-Letrozole….2.5mg(Adjuant treatment of post-menopausal women with harmone recpotor positive invasive early breast cancer).USP Specifications

Form 5A

Dy No. 1071 dated 20-08-2013 Rs.100,000/

As per SRO




Approved as per Import Policy for Finished Drugs. Panel shall confirm the anticancer facility for the manufacturing of the drug at the time of foreign inspection.

176. M/s Umar Pharma Pvt Ltd, C 5/6, Auqaf Plaza Dabgari Garden, Peshwar. Manufactured byM/s Genepharma S.A, 18th Km, Marathonosavenue-15351, Pallini-Greece.

133

Zymoplex 20mg tablet

Each tablet contains:-Tamoxifen Citrate eq to Tamoxifen…….20mg

Oestrogen Receptor Positive Early Breast Cancer

Form 5A

Dy No. 1070 dated 20-08-2013 Rs.100,000/

As per SRO

MHRA. Soltamox 20mg tablet by M/s Aurobindo.

Local. Cytotam by M/s AJ Mirza.



177. M/s Umar Pharma Pvt Ltd, C 5/6, Auqaf Plaza Dabgari Garden, Peshwar.

Zymoplex 10mg tablet

Each tablet contains:-Tamoxifen Citrate eq to

Form 5A

Dy No. 1068 dated 20-08-2013 Rs.100,000/

TGA. Cosudex 50mg by M/s Astrazeneca.

COPP issued dated 25-06-2013.GMP compliant as per

Approved as per Import Policy for Finished Drugs. Panel shall


Manufactured byM/s Genepharma S.A, 18th Km, Marathonosavenue-15351, Pallini-Greece.132

Tamoxifen…….10mg

Oestrogen Receptor Positive Early Breast Cancer

As per SRO Local. Calutide by M/s AJ Mirza.

COPP. confirm the anticancer facility for the manufacturing of the drug at the time of foreign inspection.

178. M/s Umar Pharma Pvt Ltd, C 5/6, Auqaf Plaza Dabgari Garden, Peshwar. Manufactured byM/s Genepharma S.A, 18th Km, Marathonosavenue-15351, Pallini-Greece.130

Bicamide 50mg tablet

Each film coated tablet contains:-Bicalutamide…….50mg

Adjuant to radial prostectomy or radio-therapy in patients with locally advanced prostate cancer

Form 5A

Dy No. 1069 dated 20-08-2013 Rs.100,000/

As per SRO

MHRA. Soltamox 20mg tablet by M/s Aurobindo.

Local. Arimidex by M/s ICI.



179. M/s A. Feroz & Co, Medicine Street No. 01, Marriot Road, Karachi.Manufactured byM/s HLL Lifecare Limited Akkulam, Thiruvananthapuran Kerala, India.102

Star Haemopack Single Blood Bag

Each 100ml of anticoagulant solution CPDA-1 contains:-Citric acid (Anhydrous)………..…..0.299gmSodium Citrate (Dihydrate)…..2.63gmMonobasic Sodium Phosphate (Monohydrate)

Form 5A

Dy No.1495 R&I dated 12-03-2013 Rs. 50,000 & Rs. 50,000 dated 05-11-2013 dy No.303.

As per Brand leader/500ml

COPP issued dated 03-02-2014 valid upto 2 years.GMP compliant as per COPP.

Approved as per Import Policy For Finished Drugs


………….0.222gmDextrose (Anhydrous)……………..2.90gmAdenine (Anhydrous)…..0.0275gmWFI…….QS to 100ml

Anticoagulant Solution


180. M/s A. Feroz & Co, Medicine Street No. 01, Marriot Road, Karachi.Manufactured byM/s HLL Lifecare Limited Akkulam, Thiruvananthapuran Kerala, India.

103

Star Haemopack Double Blood Bag

Each 100ml of anticoagulant solution CPDA-1 contains:-Citric acid (Anhydrous)………..…..0.299gmSodium Citrate (Dihydrate)…..2.63gmMonobasic Sodium Phosphate (Monohydrate)………….0.222gmDextrose (Anhydrous)……………..2.90gmAdenine (Anhydrous)…..0.0275gmWFI…….QS to 100ml

Anticoagulant Solution

Form 5A

Dy No.1496 R&I dated 12-03-2013 Rs. 50,000& Rs. 50,000 dated 05-11-2013 dy No.303.

As per Brand leader/500ml

COPP issued dated 03-02-2014 valid upto 2 years.GMP compliant as per COPP.

Approved as per Import Policy For Finished Drugs



181. M/s A.Feroz &Co Medicine Street no.1,Marriot road, Karachi,Pakistan.

Manufactured byShanghai PudongJinhuan Medical Products Co.,Ltd.25 LianZhen Road,Pudong New Area,Shanghai,China 201204.

No.F.3-3/2014 Reg.I(M-244) dated 26.09.2016

Star PGA Suture with needle

PGA is a synthetic absorbable surgical suture with needle.

PGA(Polyglycolicacid) Suture

Sutures

Form 5A

Diary No. 174 R&I dated 22-06-2011 Rs.15000& Rs.85,000 dated 04-11-2013 dy No. 208 R&I.

As per SRO

Sizes. USP 5-0~USP 3With round & reverse cutting

Free sale certificate is valid upto 21-02-2013.

Deferred for submission of complete details regarding sizes and shapes of sutures


ManufacturedbyShanghai PudongJinhuan Medical Products Co.,Ltd.25 LianZhen

Star Nylon Suture with Needle

Nylon Suture is a monofilament of Polyamide Nylon & the material is non-absorable.

Suture

Form 5A

Diary No. 181 R&I dated 22-06-2011 Rs.15000 & Rs.85,000 dated 04-11-2013 dy No. 208 R&I.

As per SRO

Sizes. USP 6-0~USP 1With round cutting, normal cutting & reverse cutting




Road,Pudong New Area,Shanghai,China 201204.

No.F.3-3/2014 Reg.I(M-244) dated 26.09.2016


ManufacturedbyShanghai PudongJinhuan Medical Products Co.,Ltd.25 LianZhen Road,Pudong New Area,Shanghai,China 201204.

No.F.3-3/2014 Reg.I(M-244) dated 26.09.2016

Star Chromic Catgut Suture with needle.

Chromic catgut is BSE Free & produced from intestinal serosa.

Suture.

Form 5A


As per SRO





ManufacturedbyShanghai

Star Polypropylene Suture with needle.

Polypropylene Suture is a monofilament.

Suture.

Form 5A

Diary No. 180 R&I dated 22-06-2011 Rs.15000 & Rs.85,000 dated 04-11-2013 dy No. 208 R&I

Sizes. USP 5-0~USP 2With round, round double, straight cutting & reverse cutting




PudongJinhuan Medical Products Co.,Ltd.25 LianZhen Road,Pudong New Area,Shanghai,China 201204.

No.F.3-3/2014 Reg.I(M-244) dated 26.09.2016

.

As per SRO



No.F.3-3/2014 Reg.I(M-244) dated 26.09.2016

Star Polyester Suture with needle

Braided polyester suture.

Suture

Form 5A


As per SRO




186. M/s A.Feroz &Co Medicine Street no.1,Marriot

Star PGA Suture with needle

PGLA-Poly (glycolide-co

Form 5A

Diary No. 177 R&I dated 22-06-



Deferred for submission of complete details regarding


road, Karachi,Pakistan.


No.F.3-3/2014 Reg.I(M-244) dated 26.09.2016

lactide) (90/10) braided, coated synthetic absorbable surgical suture.

Suture

2011 Rs.15000 & Rs.85,000 dated 04-11-2013 dy No. 208 R&I

As per SRO

sizes and shapes of sutures

187. M/s Samerians Enterprise, 4-First Floor, H.J. centre Kuchi Gali No.2, Marriot Road, Karachi.Manufacture byM/s Medico (Huaian) Co. Ltd, No.09 South Guangzhou Road 223005, Huaian, Jiangsu, China

164

MASTER Suture Polyglycolic with Needles

Suture

Form 5A

Diary No. 233 R&I dated 10-10-2013 Rs.100000

As per SRO

Shape Normal cutting with sizes 3/8, 1/2,, Reverse Cutting with sizes3/8, 1/2, and round with sizesFree sales certificate issued dated27-05-2013


188. M/s Samerians Enterprise, 4-First Floor, H.J. centre Kuchi Gali No.2, Marriot Road,

MASTER Suture Chromic Catgut with Needles

Suture

Form 5A

Diary No. 90 R&I dated 24-1-2014Rs.100000

Shape Normal cutting with sizes 3/8, 1/2,, Reverse

Deferred for submission of complete details regarding sizes and


Karachi.Manufacture byM/s Medico (Huaian) Co. Ltd, No.09 South Guangzhou Road 223005, Huaian, Jiangsu, China

197

As per SROCutting with sizes3/8, 1/2, and round with sizesFree sales certificate issued dated27-05-2013

shapes of sutures

189. M/s Samerians Enterprise, 4-First Floor, H.J. centre Kuchi Gali No.2, Marriot Road, Karachi.Manufacture byM/s Medico (Huaian) Co. Ltd, No.09 South Guangzhou Road 223005, Huaian, Jiangsu, China165

MASTER Suture Polypropylene with Needles

Suture

Form 5A


As per SRO

Shape Normal cutting with sizes 3/8, 1/2,, Reverse Cutting with sizes3/8, 1/2, and round with sizesFree sales certificate issued dated27-05-2013


190. M/s Samerians Enterprise, 4-First Floor, H.J. centre Kuchi Gali No.2, Marriot Road, Karachi.Manufacture byM/s Medico (Huaian) Co. Ltd, No.09 South Guangzhou Road 223005,

MASTER Suture Silk Braided with Needles

Suture

Form 5A


As per SRO

Shape Normal cutting with sizes 3/8, 1/2,, Reverse Cutting with sizes3/8, 1/2, and round with sizesFree sales certificate issued



Huaian, Jiangsu, China

196

dated27-05-2013

191. M/s Novartis Pharma Pakistan Ltd, KarachiManufactured ByM/s Catalent Germany Eberbach GmbH, Gammelsbacher Strasse 2 Eberbach D-69412 GermanyName and address of ApplicantM/s Novartis Pharmaceuticals Australia Pty Ltd, 54 Waterloo Road, North Ryde NSW 2113, Australia221

Sandimmun Neural 50mg

Each capsule contains:-Cyclosporin……50mg

Immunosuprassant

Form 5A

Dy No. 235 dated 21-03-2014 Rs.10,000.

As per SRO

COPP issued by TGA dated 13-11-2013.GMP compliant as per COPP.

Deferred for submission of CoPP to confirm free sale


Muhammad Ansar Evaluator-IRoutine applications for local manufacturer.


Brand Name(Proprietary name + Dosage Form + Strength)

Composition

Pharmacological Group

Finished product Specification

Type of Form

Initial date, diary

Fee including differential fee

Demanded Price / Pack size

Remarks on the formulation (if any) including International status in stringent drug regulatory agencies / authorities

Me-too status

GMP status as depicted in latest inspection report (with date) by the Evaluator

Remarks by Evaluator/ Decision

Decision

192. M/s Medicraft Pharmaceuticals Pvt Ltd, Industrial Estate, Hayatabad, Peshawar

2201

Irose Injection 5ml

Each ml contains:-Iron sucrose complex eq to elemental iron………..………20mgHaematinicUSP Specifications

Form 5

25-03-2013 vide diary 182 (R&I) Rs.20,000.

As per SRO

MHRA. Venofer by M/s Vifor

Local. Venofer by M/s RG

GMP compliant as per inspection report dated 27-05-2016.

Approved

193. M/s Safe Pharmaceuticals Pvt Ltd, Karachi

Source of PelletsM/s Vision Pharmaceuticals Kahuta road, Islamabad

15

Fayneec Capsule 50mg

Each capsule contains:-Diclofenac Sodium as SR pellets………..………50mg

Anti-Rheumatics

USP Specifications

Form 5

Dy No. Nil dated 17-02-2010 Rs.8000 (Photocopy) & 22-05-2013 Rs.12000 (Photocopy)

As per SRO

Deflamat 50mg-Kapseln by M/s Astellas Pharma GmbH Austria.

Local. Mobikare 50mg by M/s Barrett Hodgson

GMP compliant as per inspection report dated 09-06-2015.

Fee Rs.8000 & Rs.12,000/- are photocopy.

Approved. Photocopy fee challanswill be verified by Budget & Accounts Division and Chairman Registration Board will permit issuance of registration letter.


194. M/s Rasco Pharma, 5.5 Km Raiwind road, Lahore.

(1784)

Pioglimp-DS tablet

Each tablet contains:-Pioglitazone as HCl………..………30mgGlimepiride………..4mg

Anti diabetic


Form 5

Dy No. nil dated 29-06-2012 Rs.8000 (Photocopy) & Rs.12,000 dated 30-07-2013 dy no. 9349 R&I.

As per SRO

FDA. Duetact 4mg/30mg by M/s Takeda

Local. Piotone 4/30 by M/s Atco.

GMP compliant as per inspection date 09-09-2015.

Fee Rs.8000 is a photocopy.


195. M/s Care Pharmaceuticals, 8-Km Raiwind road, Lahore.

(1004)

Carnyl Syrup

Each ml contains:-Terbutaline Sulphate………..………0.3mg

Bronchodialator


Form 5

Dy No. nil dated 24-05-2011 Rs.8000 (Photocopy) & Rs.12,000 dated 30-07-2013 (Photocopy).

As per SRO

MHRA. Bricanyl 0.3mg/ml Syrup by M/s AstraZeneca.

Local. Britanyl by M/s Barrett Hodgson


Fee Rs.8000 & 12000 are photocopy.


196. -do-(1069)

Hepacare Syrup

Each 5ml contains:-L-Ornithine L-Aspartate…………300mgNicotinamide………..…24mgRiboflavin sodium phosphate….……….0.76mg

Liver Supplement


Form 5

Dy No. nil dated 24-05-2011 Rs.8000 (Photocopy) & Rs.12,000 dated 30-07-2013 (Photocopy).

As per SRO

Local Hepa-Merz by M/s Brookes


Fee Rs.8000 & 12000 are photocopy.Approval status in reference countries is not provided.

Deferred for the confirmation of approval status by regulatory authorities of reference countries

197. M/s Amarant Pharmaceuticals

Tica 90mg tabletEach tablet contains:-

Form-521-08-2013

FDA. Brilinta 90mg & 60mg by

Approval status in

Deferred for the


(Pvt) Ltd, 158, D. Tore, Gadap Road, Super Highway, Karachi.(2513)

Ticagrelor………90mgAnti-coagulantManufacturer’s Specifications

vide diary No. 1560 R&I Rs.20,000.As per SRO/30’s.

M/s AstrazenecaGMP compliant as per inspection dated 04-11-2015.

Pakistan is not provided.

confirmation of approval status in Pakistan

198. -do-(2514)

Esonap Tablet 375/20mgEach tablet contains:-Naproxen………….375mg Esomeprazole Magnesium….……..20mgAnalgesic/PPIManufacturer’s Specifications

Form-521-08-2013 vide diary No. 1559 R&I Rs.20,000.As per SRO/30’s.

FDA. Vimovo delay release tablet 20/375mg by M/s HorizonGMP compliant as per inspection dated 04-11-2015.

Approval status in Pakistan is not provided.

Deferred for confirmation of approval status in Pakistan

199. -do-(2515)

Mafinil 100mg tabletsEach tablet contains:-Modafinil……100mgPsychotic drugUSP Specifications

Form-521-08-2013 vide diary No. 1561 R&I Rs.20,000.As per SRO/20’s.

MHRA.Modafinil 100mg by M/s TevaLocal. V-Zac 100mg tablet by M/s WilshireGMP compliant as per inspection dated 04-11-2015.

Approved


Replies of Products deferred in 258th meeting of the Board.

200.M/s SamiPharmaceuticalsPvt Ltd,Karachi.

1892

Stein 175mg/5ml SuspensionEach 5ml of reconstitutedsuspension contains:-Erdosteine MS……..175mg(Mucolytic)Manufacturer’s Specifications

Form-54-08-2012 vidediary No. NilRs.8,000(Photocopy) &12,000 dated 29-07-2013.Rs. 178/100ml

Denmark. Erodin 175mg/5ml by M/s Orion

Local. Erdossuspension175mg/5ml byM/s Genome.

Deferred for the Following verificationof Fee. Rs.8000.Approval status inreferenceRegulatory authorities.

It has been verified that the product is in free sale in Denmark

Approved. Photocopy fee challanswill be verified by Budget & Accounts Division and Chairman Registration Board will permit issuance of registration letter

201.-do-

1891

Stein 150mg CapsuleEach Capsule contains:-ErdosteineMS………..150mg(Mucolytic)Manufacturer’s Specifications

Form-54-08-2012 vidediary No. NilRs.8,000(Photocopy) &12,000 dated 29-07-2013.Rs. 178/ 20Capsules

Denmark. Erdotin 150mg capsule by M/s Orion pharma.Local. Erdoscapsule 150mgby M/s Genome

Deferred for theFollowing verificationof Fee. Rs.8000.Approval status inreferenceRegulatory authorities.

It has been verified that the product is in free sale in Denmark


202.M/s Barett Hodgson Karachi.

94

Mobikare PlusTabletEach tablet contains:Misoprostol……..200mcgDiclofenac Sodium …. 75mg(Non-Steroidal Antiinfammatorywith Synthetic Prostaglandin E1 analog)

Form-5Dy. No: 159dated.15-07-2010Rs.8000/-Rs.12,000/-2x10’s /Rs.450/-

ArthrotecMHRA, FDA

Cytopan (Getz)

Deferred in 255th

meeting for:Original fee Challan of Rs: 12000/-.Commitment as per 251st meeting. Last inspection report.Reply of letter no.F.6-

Copy of Fee Challan provided.Commitment providedMe too product, so stability not required.Inspection report dated 03.02.16 provided.

Deferred for confirmation of double punch/layer machine from area FID.


12/2013Reg-IIdated 01 October2013 not satisfactory but board decided tosubmit stabilitystudies in previousmeeting.Proof of double core compression machine required. for stability studieswas dispensing 10-09- 2010 andManufacturing date 27-08-09.Supportive dataStability studies as per RB decision in 251st

meeting.

Picture of machine along with invoice provided.

203.-do-

95

Mobikare Plus Tablet Each tablet contains:-Diclofenac Sodium……...….50mgMisoprostol………200mcgNSAID+Prostaglandin analogueManufacturer’s Specifications

Form-515-06-2010 vide diary # 160 Rs.8000 R&I & 21-05-2013 diary # ___ Rs.12000 Photocopy attachedAs per SRO

FDA Arthrotec Tablet by M/s Searle.

Arthrotec Tablet by M/s Pfizer.

Deferred for in 254th meeting of RBDouble compression machine require to be verified.Commitment as per the decision of RB is not attached.Fresh inspection report conducted within the period of 1 year is not attached.Outline method of manufacture is not provided.Photocopy of fee Rs.12000 attached original is required.

Picture of machine along with invoice provided.Commitment provided.Inspection report dated 03.02.16.Copy of fee Challan provided.

Deferred for confirmation of double punch/layer machine from area FID and fee challan.

204.M/s Sami Pharma, Karachi.Deferred in 250th meeting

NovoTeph DR Sachet 20mgEach sachet contains:Enteric coated granules (22.5%) of

Form-5Dy. No: 8000/- dated 31-12-1012000/-

Nexium Sachet of AstraZeneca USANexum delayed relaese

Deferred for rectification of following:Source of Esomeprazole

Approved


744Esomeprazole magnesium Trihydrate eq to Esomeprazole…20mgPPIManufacturer

Source Of Pellets.M/s RA Chem Pharma Ltd, Plot #A-19/C Road No.18 IDA, Nacharam Hydrabad, Andhrapradesh, India

dated 29-07-13& Rs.80,000 vide dy No. 2791 R&I dated 17-06-2016

Rs. 450/- Pack of 14’s

Sachet of Getz(Approved in 227th meeting of RB)

granules, their composition, certificate of analysis, stability studies as per zone IV and in case of import of pellets, legalized GMP certificate of the source along with the requisite fee prescribed under the rules is not submitted.

205.-do-Deferred in 250th meeting

746

NovoTeph DR Sachet 40mgEach sachet contains:Enteric coated granules (22.5%) of Esomeprazole magnesium Trihydrate eq. to Esomeprazole…40mgPPIManufacturer

Source Of Pellets.M/s RA Chem Pharma Ltd, Plot #A-19/C Road No.18 IDA, Nacharam Hydrabad, Andhrapradesh, India

Form-5Dy. No: 8000/- dated 31-12-1012000/- dated 29-07-13Rs. 1800/-& Rs.80,000 vide dy No. 2792 R&I dated 17-06-2016 Pack of 14’s

Nexium Sachet of AstraZeneca USANexum delayed relaese Sachet of Getz(Approved in 227th meeting of RB)

Deferred for rectification of following:Source of Esomeprazole granules, their composition, certificate of analysis, stability studies as per zone IV and in case of import of pellets, legalized GMP certificate of the source along with the requisite fee prescribed under the

Approved


rules is not submitted.


Evaluator-IV Mr. Salateen Wasim Philip

Routine cases:-


Brand Name

(Proprietary name + Dosage Form + Strength)

Composition



Type of Form

Initial date, diary



International status in stringent regulatory agencies

Me-too status

GMP status as depicted in inspection report (dated)

Remarks / Observations

Decision

206. M/s CCL Pharmaceuticals (Pvt.) Ltd, 62-Industrial Estate, Kot Lakhpat, Lahore

Priority # 2263

Tablet Nitox 500mg

Each film coated tablet contains:-Nitazoxanide 500mg

Antidiarreal / antiprotozoalSpecifications:- Manufacture

Form 5 with fee Rs 20,000/- vide Dy. # nil dated 19-04-2013(Photocopy)

Pack size of SRO

FDA approved Alinia- Romark

Nitazide-Helix

Inspection report dated 11-03-2015



Priority # 2261

Tablet velamer 800mg

Each film coated tablet contains:-Sevelamer HCl 800mg

Non absorbed phosphate binderSpecifications:- Manufacture

Form 5 with fee Rs 20,000/- vide Dy. # nil dated 19-04-2013

Pack size of 30’s

FDA approved Renagel-Genzyme

Sevela-Hilton

Approved



Priority # 2264

Nitox powder for Suspension

Each 5ml of reconstituted suspension contains:-Nitazoxanide 100mg

Antidiarrheal / antiprotozoalSpecifications:- Manufacture

Form 5 with fee Rs 20,000/- vide Dy. # nil dated 19-04-2013

Pack size of 30ml

FDA approved Alinia- Romark

Nitazide-Helix

Approved

209. M/s Sami Pharmaceuticals (Pvt.) Ltd, F-95, Off. Hub River Road, S.I.T.E, Karachi

Priority # 1467Swapped

Cynfo 1g IV Injection

Each combination pack contains: Sterile powder of fosfomycin sodium eq. to Fosfomycin..1g Water for injection …10 ml (Anti biotic)

31-10-2011 Dy.No.283 Rs.8000/- Rs.l2,000/- 31-07-2013 (Photocopy)

Rs. 110/- per vial

Firm is GMP compliant as per inspection dated 03-11-2015

Proof of approval status of same dosage form in reference countries and Pakistan not provided.

Deferred for confirmation of approval status by reference regulatory authorities and Pakistan and fee challan



Capsule Colcin 8mg

Each capsule containsThiocolchicoside IP 8mg

Muscle relaxantManufacture Specification

21-03-2012 Dy.No.644 Form 5Rs.8000/- Rs.l2,000/- 31-07-2013 (Photocopy)Pack size of 10’s Rs. 300/-20s Rs. 600/-


The proposed dosage form doesn’t exist in Pakistan and reference countries.




Capsule Colcin 4mg

Each capsule containsThiocolchicoside IP 4mg


21-03-2012 Dy.No.647 Form 5Rs.8000/- Rs.l2,000/- 31-07-2013 (Photocopy)

Pack size & priec as per SRO

Muscoril – Sanofi, France

Muscoril -Searle


Approved. Photocopy fee challanswill be verified by Budget & Accounts Division and Chairman Registration


Board will permit issuance of registration letter



Injection Colcin 4mg/2ml

Each 2ml ampoule containsThiocolchicoside IP 4mgSodium chloride 16.8mg



Pack size of ampoule & price as per SRO


Muscoril -Searle


Deferred for clarification of master formulation and role of sodium chloride either active or inactive ingredient and fee challan



Colcin 0.25% Ointment

Each gram containsThiocolchicoside IP 2.5mg



Pack size of 30gm tube Rs. 280/-


The proposed dosage form doesn’t exist in Pakistan and reference countries.

Deferred for confirmation of approval status by reference regulatory authorities and Pakistan and fee challen.


Priority # 1806 swapped

Tablet Esylate 500mg

Each tablet containsEtamsylate BP 500mg

Hemostatic agent Manufacture Specification

29-08-2011 Dy # 1127 Form 5Rs. 8000/-Rs.12,000/- 31-07-2013 (Photocopy)

Pack size & price as per PRC

Dicynene 500mg – Sanofi France

Cytoplex –AGP Reg# 061420






Injection Esylate 125mg/ml

Each ml containsEtamsylate BP 125mg

Hemostatic agentManufacture Specification

13-06-2012 Dy # 1671, Form 5Rs.20,000/- (Photocopy)

Pack size of 6s Rs. 120/-


Proof of approval status of same dosage form in reference countries not provided.

Deferred for confirmation of approval status by reference regulatory authorities and Pakistan and fee challan.



Injection Esylate 250mg/2ml

Each 2ml containsEtamsylate BP 250mg

Hemostatic agentManufacture Specification

13-06-2012 Dy # 1126, Form 5Rs.8,000/-Rs. 12000/-31-07-2013 (Photocopy)

Pack size & price as per SRO

A product of OM Pharma - Switzerland

Cytoplex –AGP Reg # 061419





Tablet Viptin-Met 50/500

Each film coated tablet containsVildagliptin MS 50mgMetformin HCl BP 500mg

Anti-diabetic Manufacture Specification



TGA approved Galvumet – Novartis

Galvusmet - Novartis






Tablet Neo-Moor 50mg

Each extended release film coated tablet containsDesvenlafaxine (as succinate monohydrate) 50mg

Anti-depressant Manufacture Specification

03-10-2011Dy.No.235 Form 5Rs.8000/- Rs.l2,000/- 31-07-2013 (Photocopy)


TGA approved Pristiq – Pfizer.

Lafaxine - Genix





Tablet Neo-Moor 100mg

Each extended release film coated tablet containsDesvenlafaxine (as succinate monohydrate) 100mg

Anti-depressant Manufacture Specification



FDA approved Pristiq – Wyeth

Lafaxine - Genix





Tablet ULIP 30mg

Each tablet containsUlipristal Acetate 30mg

Synthetic Progesterone – Contraceptive Manufacture Specification


Pack size 5s Rs. 500/-

MHRA approved ellaOne-HRA

Elcat – Genix

Hormonal section of the firm is GMP compliant as per inspection dated 03-11-2015

Approved. Photocopy fee challanswill be verified by Budget & Accounts Division and Chairman Registration Board will permit issuance of


registration letter



Tablet Eriva 0.5 mg

Each film coated tablet containsEntecavir monohydrate eq to entecavir 0.5 mg

Anti-viral Manufacture Specification



MHRA approved Baraclude – Bristol

BVIR-Bosch





Tablet Viptin 50mg

Each film coated tablet containsVildagliptin MS 50mg

Anti-DiabeticManufacture Specification

18-07-2012 Dy # 1331 Form 5Rs.8000/- Rs.12,000/- 31-07-2013 (Photocopy)

Pack size as per SRO

MHRA approved Galvus – Novartis

Galvus




Priority # 1805

Mofest infusion 400mg /100ml

Each 100ml containsMoxifloxacin 400mg

AntibioticsManufacture Specification


Pack size 100ml as per SRO

Moxibar – B&H


Proof of approval of same strength in reference countries.

In proposed strength of moxifloxacin 400mg/100ml, it has been observed that crystallization occurs and product


is not stable.The Board directed firm to follow innovator brand’s formulation i.e. Moxifloxacin 400mg/250ml and submit revised Form 5.


Priority # 746

Novoteph Insta Sachet 40/1680

Each sachet containsEsomeprazole Magnesium Trihydrate USP eq to Esomeprazole 40mgSodium carbonate BP 1680mg

PPI-anti ulcer Manufacture Specification

31-12-2010 Dy.No.2275 Rs.8000/- Rs.l2,000/- 31-07-2013 (Photocopy)






Priority # 1791

Tablet Mefloq-plus 220/100

Each tablet containsMefloquine HCl eq to Mefloquine BP 220mgArtesunate MS 100mg

Anti malarialManufacture Specification

25-03-2013 Dy.No.181 Rs.20,000/-

Pack size 3s Rs. 360/-6s Rs. 720/-


The proposed formulation doesn’t exist in reference countries and Pakistan.

Deferred for confirmation of approval status by reference regulatory authorities / WHO and Pakistan.




Tablet GPRIDE-M 1/500

Each film coated tablet containsGlimepiride USP 1mgMetformin HCl BP 500mg


20-01-2012 Dy.No.474 Form 5Rs.8000/- Rs.l2,000/- 31-07-2013 (Photocopy)Pack size & price as per SRO









20-01-2012 Dy.No.475 Form 5Rs.8000/- Rs.l2,000/- 31-07-2013 (Photocopy)Pack size & price as per SRO

Hipride – Hilton



Deferred for confirmation of approval status by reference regulatory authorities and fee challan






20-01-2012 Dy.No.475 Form 5Rs.8000/- Rs.l2,000/- 31-07-2013 (Photocopy)Pack size of 10’s Rs. 300/-20s Rs. 600/-

Hipride – Hilton



Deferred for confirmation of approval status by reference regulatory authorities and fee challan.



Atpro Pedriatric Suspension

Each 5ml of reconstituted suspension containsAtovaquone USP 125mgProguanil HCl BP 50mg

Anti-Malarial Manufacture Specification

22-10-2012 Dy # 1669 Form 5Rs.20,000/- (Photocopy)

Pack size of 30ml Rs. 1200/-


Proof of approval status of same dosage form in reference countries & Pakistan not provided.

Deferred for confirmation of approval status by reference regulatory authorities / WHO and Pakistan and fee challan.




Atpro Pedriatric tablet

Each tablet containsAtovaquone USP 125mgProguanil HCl BP 50mg


29-08-2011 Dy # 95 Form 5Rs.8,000/- Rs. 12000/-31-07-2013(Photocopy)

Pack size of 6s, 12s & 30s as per SRO






Atpro Pedriatric Tablet

Each tablet containsAtovaquone USP 187mgProguanil HCl BP 75mg


29-08-2011 Dy # 96 Form 5Rs. 8000/-Rs.12,000/- 31-07-2013 (Photocopy)

Pack size of 6s, 12s & 30sPer tablet Rs. 522.50/-






Atpro DS Pedriatric Suspension

Each 5ml of reconstituted suspension containsAtovaquone USP 250mgProguanil HCl BP 100mg



Pack size of 30ml Rs. 2000/-






Tablet Dofyl 400 mg

Each tablet containsDoxofylline MS 400 mg

Bronchodilator Manufacture Specification

26-12-2012Dy # 1813 Form 5Rs. 20000(Photocopy)



Proof of approval status of same formulation in proposed strength in reference regulatory authorities

Deferred for confirmation of approval status by reference regulatory authorities / WHO and Pakistan


not provided.

and fee challan.



Dofyl 100mg/5ml Syrup

Each 5ml containsDoxofylline MS 100mg

Bronchodilator Manufacture Specification



Broxane - Opal


Proof of approval status of same formulation in proposed strength in reference regulatory authorities not provided.


235. M/s PharmEvo (Private) Limited, A-29, North Western Industrial Zone, Port Qasim, Karachi

Priority # 2539

Tablet IRMAX 100/10

Each film coated tablet containsIbresartan 100mg Amlodipine Besylate 13.87mg eq to Amlodipine 10mg

Anti-hypertensive Manufacture Specification

25-04-2013 Dy.No.1656 Form 5-DRs.50,000/-

Pack size 10s Rs. 445/- 14s Rs. 623/-28S Rs. 1246/-

Aimix – Dainnpon Sumitomo Pharma, Japan


Stability data required as per guidelines provided in 251st RB meeting.

Deferred for proof of approval status of same formulation in reference countries and Pakistan.


Priority # 2535

Tablet IRMAX 150/5

Each film coated tablet containsIbresartan 100mg Amlodipine Besylate 6.93 mg eq to Amlodipine 5mg


25-04-2013 Dy.No.1656 Form 5-DRs.50,000/-




Deferred for confirmation of approval status by reference regulatory authorities and Pakistan.


Priority # 2533

Tablet IRMAX 150/10


25-04-2013 Dy.No.1658 Form 5-DRs.50,000/-



Proof of approval status of same formulation in proposed strength in reference

Deferred for confirmation of approval status by reference regulatory authorities



regulatory authorities not provided.

and Pakistan.


Priority # 2538

Tablet IRMAX 300/5



25-04-2013 Dy.No.1658 Form 5-DRs.50,000/-






Priority # 2539

Tablet IRMAX 300/10



25-04-2013 Dy.No.1657 Form 5-DRs.50,000/-






Priority # 2266

Tablet Inosita plus 50/850

Each film coated tablet containsSitagliptin (as phosphate monohydrate)50mg Metformin HCl 850mg

PPI-anti ulcer Manufacture Specification

25-04-2013 Dy.No.266 Form 5Rs.20,000/-


TGA approved Janumet – Merck Australia

Janumet -MSD


Approved



Priority # 2536

Tablet Infixa 2.5mg

Each film coated tablet containsRivaroxiban 2.5mg

Factor Xa InhibitorManufacture Specification

29-08-2013 Dy.No.1659 Form 5-D Rs.50,000/- (Photocopy)

Pack size 7s Rs. 1050/- 10s Rs. 1550/-14s Rs. 2100/-

MHRA approved Xarelto – Bayer


Proof of approval status of same dosage form in Pakistan not provided.

Deferred for provision of stability data as per guidelines provided by the Board IN 251st

meeting and fee challan.


Priority # 2536

Tablet Infixa 5mg

Each film coated tablet containsRivaroxiban 5mg

Factor Xa InhibitorManufacture Specification

29-08-2013 Dy.No.832 Form 5-D Rs.50,000/- (Photocopy)

Pack size 7s Rs. 2100/- 10s Rs. 3000/-14s Rs. 4200/-


Proof of approval status of same dosage form in reference countries and Pakistan.



Priority # 2535

Tablet IRMAX 100/5

Each film coated tablet containsIbresartan 100mg Amlodipine Besylate 6.93mg eq to Amlodipine 5mg


25-04-2013 Dy.No.1660 Form 5-DRs.50,000/-


Aimix – Dainnpon Sumitomo Pharma, Japan



Deferred for submission of stability data required as per guidelines provided in 251st RB meeting.

244. M/s Unison Chemical worls, 15KM Raiwind Road, Lahore

Priority # 403

Tablet Cyclocam 20mg

Each tablet containsPiroxicam beta dextrin 191.2mg eq to Piroxicam 20mg

NSAIDUSP Specification

04-10-2010 Dy.No.266 Form 5Rs.8,000/-02-12-2013Rs. 12000/-(Photocopy)

Pack size 2 x 10 as per SRO

Marketing authorization to Chiesi –UK and manufactured by Chiesi Italy.

Brexin – Chiesi

Firm is GMP compliant as per inspection report.

Approved. Photocopy fee challanswill be verified by Budget & Accounts Division and Chairman Registration Board will permit


issuance of registration letter

245. M/s Highnoon Laboratories Limited, 17.5 km, Multan Road, Lahore


Tablet Niacol XR 1000mg

Each extended released tablet containsNiacin 1000mg

Anti-hyperlipidemia USP Specification

04-03-2011 Dy.No.3189 Form 5-DRs.15,000/-Rs. 35000/- 30-07-2013Dy # nil dated 30-07-2013

Pack size 7s Rs. 560/- 10s Rs. 800/-

FDA approved Niaspan – Kos Pharmaceuticals

Niaspan -Merck


Firm previously applied on Form 5-D but now product is being registered in Pakistan.

Approved






01-03-2011 Dy.No.3189 Form 5-DRs.15,000/-Rs.35000/-30-07-2013Dy # nil dated 30-07-2013

Pack size 7s PRC 10s PRC


Niaspan -Merck



Approved






01-03-2011 Dy.No.3189 Form 5-DRs.15,000/-Rs.35000/-30-07-2013Dy # nil dated 30-07-2013

Pack size 7s PRC 10s PRC


Niaspan -Merck



Approved


248. M/s MBL Pharma, Plot # B-77/A, Hub Industrial Trading Estate Balauchistan.

Priority # 1533

Tablet Melidone 10mg

Each film coated tablet containsDomperidone 10mg

Dopamine blocking agent / antiemetic BP Specification

16-04-2012 Dy.No.722 Form 5Rs.8000/- (Photocopy)

Rs.12,000/- 05-08-2013

Pack size 5 x 10 as per SRO

MHRA approved Motillium - Zentiva

Domotin - Benson

Firm is GMP compliant as per inspection report dated 02-05-2016

Approved with black box warning. Photocopy fee challanswill be verified by Budget & Accounts Division and Chairman Registration Board will permit issuance of registration letter


Priority # 871

Tablet Astin 40/240

Each tablet containsArtemether 40mgLumefantrine 240mg

AntimalarialManufacture Specification

17-02-2011 Dy.No.492 Form 5Rs.8000/- (Photocopy)Rs.12,000/- 05-08-2013 Pack size 8s & 16s as per SRO

WHO recommended formulation

Amalar - Bloom




Priority # 1569

Fasid Cream 15gm

Each gram containsFusidic Acid 20mg

AntibioticsBP Specification

27-04-2012 Dy.No.753 Rs.8000/- PhotocopyRs.12,000/- 05-08-2013

Pack size of 15gm as per SRO

MHRA approved Fusidin - Leo

Sidic - Epoch


Approved with change of brand name. Photocopy fee challanswill be verified by Budget & Accounts Division


and Chairman Registration Board will permit issuance of registration letter


Priority # 875

Mb Din suspension 60ml

Each 5ml of reconstituted suspension containsCephradine USP 250mg

AntibioticsUSP Specification

19-02-2011 Dy.No.505-A Rs.8000/- Photocopy Rs.12,000/- 05-08-2013

Pack size of 60ml as per SRO

FDA approved brand

Velosef




Priority # 1549

Viospan DS suspension 30ml

Each 5ml of reconstituted suspension containsCefixime (as trihydrate) 200mg

AntibioticsUSP Specification



FDA approved brand Suprax -Lupin

Caricef - Sami




253. M/s Pliva Pakistan (Pvt.) Ltd, Plot # B-77, Hub Industrial Trading Estate, Balauchistan.

Priority # 862

Tablet Diamet

Each tablet containsGlucosamine Sulphate USP 500mgChondroitin Sulphate USP 400mg

Dietary supplement USP Specification

17-02-2011 Dy.No.487 Rs.8000/- Photocopy Rs.12,000/- 19-9-2013 Pack size 2 x 10s Rs. 320/-


Proof of approval status of same dosage form in reference countries.

Pack of locally registered brand.



Priority # 864

Tablet Meelas 5mg

Each chewable tablet containsMontelukast Sodium USP equivalent to Montelukast 5mg

BronchodilatorsUSP Specification

17-02-2011 Dy.No.486 Form 5Rs.8000/- (Photocopy) Rs.12,000/- 19-9-2013 Pack size 10s Rs. 170/-14s Rs. 240/-

MHRA approved Singlulair –Merck,UK

Amisped - Sanofi




Priority # 863

Tablet Meelas 10mg

Each film coated tablet containsMontelukast Sodium USP equivalent to Montelukast 10mg

BronchodilatorsUSP Specification

17-02-2011 Dy.No.485 Rs.8000/- (Photocopy) Rs.12,000/- 19-9-2013 Pack size 10s Rs. 190/-14s Rs. 310/-

MHRA approved branf of Accord

Asfree-Medisure





Priority # 1570

Fomatin Suspension 60ml

Each 5ml containsFamotidine 10mg

Anti ulcerUSP Specification

10-05-2012 Dy.No.859 Rs.8000/- PhotocopyRs.12,000/- 05-08-2013 Pack size as per SRO


i. Applicants shall revise their formulation as per innovator (new registration application with complete fee) within six months if manufacturing facility is approved by CLB.

ii. For already registered drugs, same procedure as mentioned above (at Sr. No. i) shall be adopted. Otherwise show cause notice shall be issued for de-registration of registered drugs in this formulation.

iii. All such application shall be

Deferred as per decision of 250th RB meeting as under:-i. Applica

nts shall revise their formulation as per innovator (new registration application with complete fee) within six months if manufacturing facility is approved by CLB.

ii. For already registered drugs, same procedure as mentioned above (at Sr. No. i) shall be adopted. Otherwise show cause notice shall be issued for de-


processed on priority basis.

registration of registered drugs in this formulation.

iii. All such application shall be processed on priority basis.


Priority # 1571

Vanax Suspension 60ml

Each 5ml containsDexibuprofen 100mg

NSAIDManufacture Specification



Dexib –Tabros





Priority # 1547

Kanz Dry Powder Suspension

Each 5ml of reconstituted suspension containsCiprofloxacin HCl.2H2O eq to Ciprofloxacin 250mg




Novidat - Sami



Product is under review as innovator brand is in base form of active ingredient while firm has applied as salt form.

Deferred for Proof of

approval status of same dosage form in reference countries.

Product is under review as innovator brand is in base form of active ingredie


nt while firm has applied as salt form.

Fee challan

259. M/s Asian Continental (Pvt.) Ltd, D-32, S.I.T.E, Super Highway, Karachi.

Priority # 1630

Artim Plus Suspension

Each 5ml of reconstituted suspension containsArtemether 15mgLumefantrine 90mg

Antimalarial Manufacture Specification

21-05-2012 Dy.No.955 Rs.8000/- Rs.12,000/- 05-09-2013 (Photocopy)

Pack size 30ml x 60ml as per SRO


Artem -Hilton


Approved with change of brand name. Photocopy fee challanswill be verified by Budget & Accounts Division and Chairman Registration Board will permit issuance of registration letter

260. M/s Asian Continental (Pvt.) Ltd, D-32, S.I.T.E, Super Highway, Karachi.

Priority # 1593

Injection Vitadol 5mg

Each 1ml ampoule containsCholecalciferol (Vit. D3) 5mg

Vitamin USP Specification

17-05-2012 Dy.No.884 Rs.8000/- Rs.12,000/- 05-09-2013 (Photocopy)

Pack size 30ml x 60ml as per SRO

Vit D3 B.O.N, France

Indrop-D , Neutro




261. M/s Atco Laboratories Limited, B-18, S.I.T.E, Karachi

Priority # 1502

Afantrine DS Dry Suspension

Each 5ml of reconstituted suspension containsArtemether MS 30mgLumefantrine MS 180mg

Antimalarial Manufacture Specification

16-02-2012 Dy.No.581 Rs.8000/- Photocopy Rs.12,000/- 05-08-2013

Pack size of 30ml & 60ml as per SRO


Artem plus - Hilton

Firm is GMP compliant



Priority # 1990

Vorinaz Powder for Oral suspension

Each 5ml of reconstituted suspension containsVoriconazole 200mg

(Triazole Anti-fungal agent) Manufacture Specification

19-11-2012 1774 Form 5-D Rs.50,000/- (Photocopy)


Vfend-MHRA approved

Hongos-CCL Reg#077021

GMP compliant section

Firm previously applied on Form 5-D but now product is locally registered and firm has submitted application of prescribed Form 5.



Priority # 1500

Tablet Xecam-P 4/500

Each film coated tablet containsLornoxicam MS 4mgParacetamol BP 500mg

(Muscle relaxant ) Manufacture Specification

16-02-2012 Dy.No.584 Form 5-DRs.15000/- Rs.35,000/- 05-08-2013 (Photocopy)

Pack size of 14s & 28s as per SRO






Priority # 1501

Tablet Xecam-P 8/500

Each film coated tablet containsLornoxicam MS 8mgParacetamol BP 500mg

(Muscle relaxant ) Manufacture Specification

16-02-2012 Dy.No.584 Form 5-DRs.15000/- Rs.35,000/- 05-08-2013 (Photocopy)






Priority # 2164

Tablet Panel 10mg

Each film coated tablet containsPerampanel 10mg

(Antiepileptic) Manufacture Specification

29-03-2011 Dy.No.490 Form 5-DRs.15000/- Rs.35,000/- 05-08-2013

Pack size of 7s, 14s & 28s Per tablet Rs. 375/-

MHRA approved Fycompa - Eisai



Deferred for provision of stability data required as per guidelines provided in 251st RB meeting.


Priority # 2375

Tablet Alodip-H

Each film coated tablet containsAliskiren (as hemifumarate) MS 300 mgAmlodipine (as besylate) BP 5mgHydrochlorthiazide BP 12.5mg

(Cardiovascular drug ) Manufacture Specification

29-03-2011 Dy.No.490 Form 5-DRs.15000/- Rs.35,000/- 05-08-2013


USFDA approved Amturnide- Novartis





Priority # 2656

Tablet Aloglip-M 12.5/1000

Each film coated tablet containsAlogliptin Benzoate MS eq to Alogliptin 12.5mgMetformin HCl BP 1000mg

(Cardiovascular drug ) Manufacture Specification

24-10-2013Dy.No.273 Form 5-DRs.15000/- Rs.35,000/- 05-08-2013

Pack size of 10s, 14s 20s & 30s as per SRO

USFDA approved Kazano -Takeda





268. M/s Pacific Pharmaceuticals Limited, 30th km, Multan Road, Lahore

Priority # 1981

Rifin Dispersible tablet

Each dispersible tablet containsRifampicin 60mgIsoniazid 30mg

(Antimycobacterial) Manufacture Specification

16-11-2012 Form 520,000(Photocopy)

Pack size of 28s Rs. 335.40/-56s Rs. 670.79/-

WHO -UN prequalified formulation


To deposit remaining fee for prescribed Form 5-D.

Stability studies as per guidelines provided in 251st

RB meeting.

Deferred for following shortcomings To

deposit remaining fee for prescribed Form 5-D.


RB meeting.

269. M/s Pacific Pharmaceuticals Limited, 30th km, Multan Road, Lahore

Priority # 1982

Rifin Dispersible tablet

Each dispersible tablet containsRifampicin 60mgIsoniazid 60mg

(Antimycobacterial) Manufacture Specification

16-11-2012 Form 520,000(Photocopy)

Pack size of 28s Rs. 337.93/-56s Rs. 675.86/-

WHO -UN prequalified formulation


To deposit remaining fee for prescribed Form 5-D.


RB meeting.

Deferred for following shortcomings To

deposit remaining fee for prescribed Form 5-D.


RB meeting.


270. M/s NabiQasim Industries (Private) Limited, 17/24, Korangi Industrial Area, Korangi, Karachi

Priority # 2294

Kenazol 2% Lotion

Each ml contains: Ketoconazole… 20 mg

(Antifungal agent) Manufacture Specification

08-05-2013 Dy.No.304 Form 5Rs.20,000/- (Photocopy)


Conaz - Atco

Firm is GMP compliant

To provide proof of approval of same dosage form in reference countries.


271. M/s Surge Laboratories (Private) Limited, 10th, KM Faisalabad Road, Bikhi District, Sheikhupura.


Dexol 5% infusion

Each 100 ml contains: Dextrose Anhydrous USP 5gm (5% w/v)

(Carbohydrate) USP Specification

27-6-2011 Dy # 14878000/- Form 512000/16-01-2014

Pack size 100ml, 500 ml, 1000ml as per SRO

To provide primary packaging details.

Deferred for Primary

packaging details.

Proof of approval status of same dosage form in same primary packing by reference regulator authorities and Pakistan.



Injection Alset

Each 5ml vial contains: Palonosetron (as HCl) 0.25mg

(5HT3 receptor antagonist) Manufacture Specification

27-6-2011 Dy # 14878000/- Form 512000/16-01-2014

Pack size 100ml, 500 ml, 1000ml as per SRO

MHRA approved Aloxi – Chughai

Aloxetron – Atco approved in 228th meeting for improt

Me too status needs confirmation

Deferred for Confirm

ation of pack size.

Provision of approval status of same dosage form in Pakistan, as reference mentioned


in Form 5 is not correct.



Preslin Injection 20mg

Each ml contains: Hydralazine HCl USP 20mg

(Antihypertensive) USP Specification

26-4-2012 8000/- Form 512000/16-01-2014 (Photocopy)


Complete form 5 required.

Original challan receipt required.

Complete description of dosage form required.

Commitment required as per decision of 251st

RB meeting.

Latest inspection report required.

Deferred for provision of Complete

form 5. Original

challan receipt.

Complete description of dosage form.

Proof of approval status of same dosage form in reference countires and Pakistan

Commitment as per decision of 251st

RB meeting.

Latest inspection report.

Fee challan


Water for injection

Water for injection 50ml

(Diluent) USP Specification

29-8-2012 8000/- Form 512000/16-01-2014 (Photocopy)


Complete form 5 required.


Complete

Deferred for provision of Complete

form 5. Original

challan receipt.

Clinical


Priority # 1853 description of dosage form required.


RB meeting.


Indication of dosage form.

Indication

Proof of availability of same pack size in reference countires and Pakistan.

Proof of approval status of same dosage form in reference countires and Pakistan


RB meeting.


Intended use.

Fee challan


Priority # 1204

Sunvega 39 mg injection

Each 0.25ml pre filled syringe containsPaliperidone palmitate 39mg(Prolonged released)

(Dopamine antagonist) USP Specification

29-8-2012 8000/- Form 512000/16-01-2014 (Photocopy)


USFDA approved Invega sustenna –Janssen

Complete form 5-D required.


Complete description of

Deferred for Complete

form 5-D. Original

challan receipt.

Complete description of dosage


dosage form required.


RB meeting.


Proof of manufacturing facility of pre-filled syringes.

form. Commit

ment as per decision of 251st

RB meeting.


manufacturing facility of pre-filled syringes.

Fee challan


Priority # 1545

Sunvega 39 mg injection

Each 0.25ml pre filled syringe containsPaliperidone palmitate 39mg(Prolonged released)

(Dopamine antagonist) USP Specification

29-8-2012 8000/- Form 512000/16-01-2014 (Photocopy)


USFDA approved Invega sustenna –Janssen

Complete form 5-D required.




RB meeting.

Latest inspection report

Deferred for Complete

form 5-D. Original

challan receipt.



RB meeting.


manufacturing facility of


required. Proof of

manufacturing facility of pre-filled syringes.

pre-filled syringes.

Fee challan

277. M/s Venus Pharma, 23km, Multan Road, Lahore

Priority # 498

Viofer Injection

Each 5ml ampoule containsIron sucrose eq to elemental iron 100mg (20 mg / ml)

(Hematinic) USP Specification

02-12-2010 Dy # 4534 8000/- Form 512000/05 -11-2013 (Photocopy)


FDA approved Venofer – Lutipold

Venofer – RG

GMP compliant section vide inspection report dated



Priority # 668

Viofer Infusion 100 ml

Part IEach 5ml ampoule containsIron sucrose eq to elemental iron 100mg (20 mg / ml)Part IISodium Chloride 0.9%

(Hematinic) USP Specification


Pack size 100ml Rs. Rs. 1000/-

FDA approved Venofer – Lutipold

Venofer – RG


Deferred for confirmation of approval status of same formulation by refrence regulatory authorities and Pakistan and fee challan.



Priority # 669

Normal Saline 0.9%

Each ml containsSodium Chloride 9 mg

(Electrolyte) USP Specification


Pack size 100ml Rs. 45/-


Proof of approval status of same dosage form in glass bottle as primary container

Deferred for confirmation of approval status of same formulation in glass bottle as primary container by refrence regulatory authorities and Pakistan and fee challan


Priority # 499

Tablet Apresolin - 10

Each tablet containsHydralazine HCl 10mg

(Antihypertensive) USP Specification

02-11-2010Dy # 4207 8000/- Form 512000/05 -11-2013 (Photocopy)

Pack size 1 x 50 Rs. 103/-

FDA approved Aspresolin – Novartis


The product is not yet registered in Pakistan in proposed strength

Deferred for Applicati

on on prescribed Form 5-D along with other legal and codal formalities because the proposed formulation is not yet registered in Pakistan.

Fee challan


281. M/s Hilton Pharma (Pvt.) Ltd, 13, Sector 15, Korangi Industrial Area, Karachi


Colt Drops 125mg / 5ml

Each 5ml after reconstitution containsClarithromycin 125mg(granules for oral suspension)

(Antibiotics) USP Specification

Form 5 with prescribed fee of Rs 20,000 vide Dy # 1168 dated 03-07-2013

Pack size as per PRC

MHRA approved brand of Sandoz

Klaricid – Abbott


Approved with change of brand name because proposed brand name resembles with already registered brand name.



Tablet Maxit-Neuro

Each film coated tablet containsDiclofenac Sodium 50mgThiamine(Vitamin B1) 50mgPyridoxine HCl (Vit B6) 50mgCyanocobalamin (Vitamin B12) 250 mcg

(pain reliever) Manufacture Specification


Pack size as per PRC


Proof of approval status of same dosage form in reference countries and Pakistan.

Rejected as formulation is not approved by reference regulatory authorities and Pakistan.



Hilto-D Sachet

Each Sachet containsVitamin D3 (Cholecalciferol) 600,000 IU

(Vitamin) Manufacture Specification

Form 5-D with prescribed fee of Rs 50,000 vide Dy # 1408 dated 19-07-2013



Firm needs to provide following documents / information for completion of application. Proof of

approval status of same dosage form in reference countries.

Deferred for confirmation of approval status of same formulation / dosage form by reference regulatory authorities.




Capsule toploss 7.5/46

Each capsule containsPhentermine 7.5 mgTopiramate 46 mg

(anti-epileptic) Manufacture Specification


Pack size 10s Rs. 4300/-20s Rs. 8600/-30s Rs. 12,900/-

FDA approved Qsymia , Vivus


Firm needs to provide following documents / information for completion of application. Complet

e description of dosage form.

Formulation details as per innovator brand.

Stability data as per guidelines of 251st RB meeting.

Deferred of Complet






Capsule toploss 11.25/69

Each capsule containsPhentermine 11.25 mgTopiramate 69 mg








Formulation details

Deferred for Complet



Stability data as per guidelines of


as per innovator brand.


251st RB meeting.



Capsule toploss 15/92

Each capsule containsPhentermine 15 mgTopiramate 92 mg















Priority # 2387

Ariza Injection IM

Each 1.3ml vial containsAripiprazole 9.75mg

(psychotropic drug) Manufacture Specification


Pack size 5s Rs. 2254/-10s Rs. 4508/-

FDA approved Abilify – Otsuka

GMP compliant section vide

Proof of segregated manufacturing facility for psychotropic injection not

Deferred for provision of stability data as per guidelines provided in 251st RB meeting.


30s Rs. 13,524/- inspection report dated

provided.


Priority # 2391

Ariza oral solution

Each ml containsAripiprazole 1mg

(anti-psychotic) Manufacture Specification


Pack size 60ml Rs. 5880/-120ml Rs. 11170/-240ml Rs. 20000/-

FDA approved Abilify – Otsuka


Proof of segregated manufacturing facility for psychotropic oral solution not provided.

Deferred for provision of stability data as per guidelines provided in 251st RB meeting.


Priority # 2346

Tablet Hilpru 600 mg

Each film coated tablet containsPrulifloxacin 600mg

(Antibiotics) Manufacture Specification



Tablet Unidrox - Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A. Viale Amelia 70 - 00181 Rome, Italy

Pruking 600mg, Wilshire


Me too status needs confirmation.

Deferred for confirmation of approval status in Pakistan.

290. M/s Medisearch Pharmacal (Pvt.) Ltd, 5km, Raiwind Manga Road, Lahore

Priority # 669

Gerd Cure Tablet

Each tablet containsItopride HCl 50mg

(prokinetic / antiemetic) Manufacture Specification

31-08-2012 Dy # 8556 8000/- Form 512000/05 -11-2013


Ganaton –Abbott


Product under review.

Deferred as product is under review and latest inspection report of the firm conducted within one


year and decision of CLB on recommendation of PQCB, Punjab


Priority # 988

Capsule Diclofast 50mg

Each capsule containsDiclofenac Sodium 50 mg

(NSAID) Manufacture Specification

31-08-2012 Dy # 8554 8000/- Form 512000/31 -07-2013


Phlogin - brookes


Complete description of dosage form not provided.



Proof of approval status of dosage form in reference countires.

Latest inspection report of the firm conducted within one year and decision of CLB on recommendation of PQCB, Punjab



Priority # 1078

Tablet Nexpro 550mg

Each tablet containsNaproxen sodium 550mg eq to Naproxen 500mg

(NSAID) USP Specification

31-08-2012 Dy # 8554 8000/- Form 512000/31 -07-2013


Anex – Pharmevo


Complete description of dosage form not provided.



Proof of approval status of dosage form in reference countires.

Latest inspection report of the firm conducted within one year and decision of CLB on recommendation of PQCB, Punjab

293. M/s Pharmatec Pakistan (Pvt.) Ltd, D-86/A, S.I.T.E, Karachi.

Priority # 1204

Tablet Morease SR

Each film coated delayed released tablet containsDoxylamine Succinate 10mgVitamin B6 10mgFolic Acid 2.5mg

(Antihistamine / ant allergy / anti nauseant ) Manufacture Specification

29-8-2012 8000/- Form 512000/16-01-2014 (Photocopy)

Pack size of 30’s as per SRO

Diclectin – Canada

Envepe- RG Pharmaceutica

The proposed formulation is not as per innovator brand and me too in Pakistan.

Original challan receipt

Defererd for The

proposed formulation doesn’t match with the already registered brands because


required. proposed formulation contains folic acid which is not in formulation of already registered brands.


Approval status by reference regulator authorities.

Fee challan

294. M/s Pharmatec Pakistan (Pvt.) Ltd, D-86/A, S.I.T.E, Karachi.

Priority # 1956

Tablet Lanthanate 500mg

Each chewable tablet containsLanthanum (as carbonate hydrate) 500mg

(Phosphate Binder ) Manufacture Specification

29-8-2012 8000/- Form 512000/16-01-2014 (Photocopy)

Pack size of 30’s as per SRO

USFDA approved Fosrenol – DSM Pharmaceuticals –Greenville BlvdUS Patent 5,968,976




RB meeting.

Latest

Deferred for Original

challan receipt.



RB meeting.



inspection report required.

Proof of approval status of same dosage form in Pakistan.

Proof of approval status of same formulation / dosage form in Pakistan.

Fee challan

295. M/s Genix Pharma (Pvt.) Ltd, 44,45-B, Korangi Creek Road, Karachi.

Priority # 643

Tablet Metvil

Each film coated tablet containsMetformin HCl 1000mgVildagliptin 50mg

(Anti-diabetic) Manufacture Specification

30-11-2010 Dy No.2076 Form 5Rs.8000/- Rs.12,000/- 25-9-2013 (Photocopy)

Pack size of 10’s & 30’s as per SRO

MHRA approved Eucreas –Novartis

Galvusmet-Novartis



296. M/s Obsons Pharmaceuticals, 209-S, Industrial Estate. Kotlakhpat, Lahore

Priority # 1170

Capsule Flucob 150mg

Each capsule containsFluconazole 150mg


22-6-2011 8000/- Form 512000/19-12-2013 (Photocopy)


MHRA approved Azocan-P , FDC

Fluderm-NabiQasim

GMP compliant section vide inspection report dated 07-07-2015.




Priority # 1171

Tablet OBMOX 400 mg

Each film coated tablet containsMoxifloxacin (as HCl) 400mg


Dy # 270522-6-2011 Rs. 8000/- Form 5Dy # 128119-12-2013Rs. 12000/-(Photocopy)

Pack size1 x 5s Rs. 692.95/-

MHRA approved Avelox

Moxiget - Getz




Priority # 1181

Tablet AZICOB 250mg

Each film coated tablet containsAzithromycin (as dihydrate)250mg


Dy # 270522-6-2011 Rs. 8000/- Form 5Dy # 128119-12-2013Rs. 12000/-(Photocopy)

Pack size6s as per SRO

MHRA approved brand of actavis, UK

Azopik – Wise



299. M/s Irza Pharma (Pvt.) Ltd, 10.2km, Lahore Sheikhupura Road, Lahore

Priority # 1917

Zeesulf Suspension

Each 5ml of suspension containsZinc Sulphate USP 20mg

(Antidiarrheal ) USP Specification

18/10/2012 Fee Rs. 20,000/-Form 5 (Photocopy)



GMP compliant section vide inspection report dated 21-03-2016

Product is under review and waiting for comments of WHO.

Deferred as product is under review and sent for comments of WHO.



Priority # 1914

Tablet Vilvus 50mg

Each tablet containsVildagliptin 50mg


18/10/2012 Dy # 211 dated 17-10-2012Fee Rs. 20,000/-Form 5 (Photocopy)


MHRA approved Galvus-Novartis

Galvus –Novartis




Priority # 1014

Injection I-Mide

Each 2ml containsMetoclopramide HCl 10mg (5mg/ml)

(Anti-dopaminergic) Manufacture Specification

18/10/2012 Dy # 211 dated 17-10-2012Fee Rs. 20,000/-Form 5 (Photocopy)


Metoclopramide Injection – Sandoz Canada

Maxolon-GSK




Priority # 1916

Tablet Gabatin 100mg

Each tablet containsGabapentin USP 100mg

(Anti-epileptic) Manufacture Specification



Gabapen – Batala




303. M/s Irza Pharma (Pvt.) Ltd, 10.2km, Lahore

Tablet Gabatin 300mg

Each tablet containsGabapentin USP 300mg


Gabapen – Batala

GMP

Proof of approval status of

Deferred for confirmation of


Sheikhupura Road, Lahore

Priority # 1915

(Anti-epileptic) Manufacture Specification


compliant section vide inspection report dated 21-03-2016

same dosage form in reference countries not provided.

approval status by reference regulatory authorities and fee challan


Priority # 1785

Neotral Sachet

Each sachet containsSodium Chloride 3.5gmPotassium Chloride 1.5gmSodium Citrate 2.9gmDextrose Anhydrous 20gm

(Electrolyte) Manufacture Specification

02-07-2012 Rs. 8,000/-Form 5 17-05-2013Rs. 12000/-(Photocopy)


Approved in 247th RB meeting being high osmolar formulation

Peditral -Searle


Firm doesn’t possess Sachet (General) Section

Rejected as firm doesn’t possess Sachet (General) Section

305. M/s Lahore Chemical & Pharmaceutical Works (Pvt.) Ltd, 137-Ferozpur Road, Lahore

Priority # 1867

Tablet ARTEMEF DS


(Antimalarial) Manufacture Specification

05-09-2012 Rs. 8,000/-Form 5 (Photocopy)Dy#113416-12-2013Rs. 12000/-



Artem - Hilton

Latest inspection report conducted within one year.

Commitment required as per decision of 251st RB meeting.

Approved with change of brand name. firm has provided requisite documents.Photocopy fee challanswill be verified by Budget & Accounts Division and Chairman Registration Board will permit issuance of registration letter


306. M/s Lahore Chemical & Pharmaceutical Works (Pvt.) Ltd, 137-Ferozpur Road, Lahore

Priority # 1868

Tablet ARTEMEF DS


(Antimalarial) Manufacture Specification

05-09-2012 Rs. 8,000/-Form 5 (Photocopy)Dy#113116-12-2013Rs. 12000/-



Artem - Hilton

Latest inspection report conducted within one year.

Commitment required as per decision of 251st RB meeting.

Approved with change of brand name. firm has provided requisite documents.Photocopy fee challanswill be verified by Budget & Accounts Division and Chairman Registration Board will permit issuance of registration letter

307. M/s Mass Pharma (Pvt) Ltd, 17-km, Ferozepur Road, Lahore

Priority # 2038

Tablet VIMC-D

Each film coated tablet contains:- Ossein Mineral complex 83mg eq. to residual mineral salts 24.8mg, collagen 224mg, other protenins 88.4mg, trace elements fl,mg, Zn, Fe, Ni, Cu) corresponding to approx 440mg hydroxyapatite.

Dy# 1027610-12-2012 Rs. 20,000/-Form 5 (Photocopy)

Pack size Per tablet Rs. 10/-

Onsate – AGP Deferred for verification of atomic absorption spectrophotometer by area FID required for analytical testing of the product and fee challan

308. M/s Sharex Laboratories (Pvt.) Ltd, KLP, Road, Sadiqabad

Priority # 285

Pyodex Solution 10%

Each 100ml contains:-Iodinated povidone 10gm eq to iodine 1gm

Antiseptic USP specification

Dy# 353916-03-2011 Rs. 8,000/-Form 5Dy #108429-05-2014

Pack size Per tablet Rs. 10/-

MHRA approved Betadine

Poviderm -Bexter

Latest inspection report required

Deferred for Latest inspection report conducted within one year and section


309. M/s Sharex Laboratories (Pvt.) Ltd, KLP, Road, Sadiqabad

Priority # 285

Cynoplex Injection

Each 2ml ampoule contains:-Vitamin B1 BP 10mgVitamin B2 BP 2mgVitamin B6 BP 5mgNicotinamide BP 75mgDexpanthanol BP 5mg

Vitamin Manufacture specification

Dy# 327108-03-2011 Rs. 8,000/-Form 5Dy #108729-05-2014


Murfy plex –Murfy

Latest inspection report required

Deferred for Latest

inspection report conducted within one year.

Confirmation of approval status by reference regulator authorities and Pakistan

310. M/s Basel Pharmaceuticals, 227-Phase II, Multan Industrial Estate, Multan

Priority # 285

Capsule Befol Vit

Each capsule contains:-Dried ferrous Sulphate 150mgFolic acid 0.5mgThiamine mononitrate 2mgRiboflavin 2mgPyridoxine HCl 1mgNicotinamide 10mgAscorbic acid 50mg

VitaminsManufacture specification

Dy# 84321-11-2013 Rs. 20,000/-Form 5


Fefol-vit, GSK Latest inspection report requiredCommitment requiredComplete manufacturing method required

Deferred for Latest

inspection report required


RB meeting.

Complete manufacturing method.

Vitamin policy

311. M/s Zafa Pharmaceutical Laboratories (Pvt.) Ltd, L-1/B, Block 22, Federal “B” Industrial Area, Karachi

Priority # 2742

ZipPain 25mg Capsule

Each softgel capsule containsDiclofenac Potassium 25mg

(NSAID) Manufacture Specification

28-11-2013 Dy.No.2039 Form 5-DRs.50,000/-(Photocopy)


FDA approved Zipsor - US Patents: 6,365,180; 7,662,858; 7,884,095; 7,939,518; 8,110,606; 6,287,594; 8,623,920

Stability data as per guidelines provided in 251st RB meeting.

Deferred for provision of Stability data as per guidelines provided in 251st RB meeting and fee challan


Distributed by: Depomed, Inc. Newark, CA 94560, USA Issued: 5/2016

312. M/s Zafa Pharmaceutical Laboratories (Pvt.) Ltd, L-1/B, Block 22, Federal “B” Industrial Area, Karachi

Priority # 1989

Tablet Durata 30 mg

Each film coated tablet containsDapoxetine HCl eq to Dapoxetine 30mg

(SSRIs) Manufacture Specification

28-11-2013 Form 5Rs.20,000/-(Photocopy)


MHRA approved Priligy

The product in proposed strength is not yet registered in Pakistan.

Deferred for provision of application on prescribed Form 5-D because product in proposed strength is not yet registered in Pakistan and fee challan

313. M/s Highnoon Laboratories Ltd, 17.5km, Multan Road, Lahore

Priority # 2381

Tablet Cidine XR

Each extended released tablet containsCinitapride as acid tartrate 3mg

(Prokinetic drugs) Manufcature Specification

22-11-2012Fee Rs. 20,000/-Form 5 (Photocopy)


Proof of approval status of same formulation in same strength in reference countries & Pakistan.

Deferred for confirmation of approval status of same formulation by reference regulatory authorities and Pakistan and fee challan


Priority # 2747

Tablet Cidine XR

Each tablet containsDexrabeprazole sodium 5mg

(Proton Pump Inhibitor) Manufcature Specification

3-10-2011 Form 5-D 15000/- 35000/30-07-2013 (Photocopy)


Proof of approval status of same formulation in same strength in reference

Deferred for confirmation of approval status of same formulation by reference


14s Rs. 210/-28s Rs. 420/-

countries & Pakistan.

regulatory authorities and Pakistan and fee challan



Capsule Tres-Orix forte

Each capsule containsCarnitine Hydrochloride 150mg Lysine Hydrochloride 150mg Coenzyme B12 1mg Cyproheptadine orotate 1.5mg

(Nutritional Supplement)

18-10-2012Form 520000/- (Photocopy)

Pack size 10s Rs. 100/-14s Rs. 200/-28s Rs. 300/-

Proof of approval status of same formulation in same strength in reference countries & Pakistan.

Deferred for confirmation of approval status of same formulation by reference regulatory authorities and Pakistan nd fee challan.



Tablet Spasnol 80/80

Each tablet containsPhlorglucinol 80mgTrimethylphlorglucinol 80mg

(Antispasmodic)Manufacture specification

18-10-2013Form 520000/- (Photocopy)


Spasfon –France

Spasfon -Himont

Deferred as product / formulation is under review.The Board advised to issue reminder for to experts for their opinion

317. M/s Seatle (Private) Limited, 45-km, Multan Road, Lahore

Priority # 2414

Tablet Exlem 3mg

Each tablet containsBromazepam 3mg

(Benzodiazepines)Manufacture specification

18-10-2013Form 520000/- (Photocopy)


TGA approved Lexotan- Roche

Lexotanil Roche

Proof of manufacturing facility of tablet psychotropic

Rejected as firm doesn’t possess segregated manufacturing facility of tablet psychotropic as per requirement of Central Licensing Board.


318. M/s Merck (Private) Limited, 7, Jail Road, Quetta

Priority # 1969

Tablet Osteolock

Each film coated tablet containsGlucosamine Sulphate 2KCl USP eq. to Glucosamine Sulphate 500mg Chondroitin Sulphate USP 400mg

(Osteoarthritis) Manufacture specification

05-11-2012 Dy # 1728 Form 5Rs.20,000/- (Photocopy)


Gevolox –Hilton

GMP compliant section vide inspection report dated 13-14 May 2016

Deferred for confirmation of approval status of same formulation by reference regulatory authorities and fee challan.


Priority # 1429

Lumairia Dry Suspension

Each 5ml of reconstituted suspension containsArtemether 15mgLumefantrine 90mg

(Antimalarial) Manufacture specification

16-11-2011 Dy.No.361 Form 5Rs.8000/- Rs.12,000/- 05-09-2013 (Photocopy)



Artem – Hilton




Priority # 1424

Lumairia Tablet 80/480

Each Tablet containsArtemether 80mgLumefantrine 480mg





Artem – Hilton





Priority # 1431







Artem – Hilton




Priority # 1428







Artem – Hilton




Priority # 2049

Mercip Powder for suspension 250mg/5ml

Each 5ml of reconstituted suspension containsCiprofloxacin HCl.2H2O USP eq to Ciprofloxacin 250mg

(Antibiotics) USP specification





The innovator brand is in base form while it is in salt form.

Deferred as product is under review.

The innovator brand is in base form while it is in salt form.



Priority # 2048

Mercip Powder for suspension 125mg/5ml

Each 5ml of reconstituted suspension containsCiprofloxacin HCl.2H2O USP eq to Ciprofloxacin 250mg

(Antibiotics) USP specification

13-12-2012 Dy.No.361 Form 5Rs. 20,000/- (Photocopy)



The proposed dosage form doesn’t exist in this strength in reference countries.

Rejected as the proposed dosage form doesn’t exist in proposed strength in reference countries.

325. M/s Star Laboratories (Pvt.) Ltd, 23-km, Multan Road, Lahore


Irosoft Injection

Each 5ml containsFerric sucrose complex eq to elemental iron 100mg

(Iron preparation) USP specification

17-07-2013Form 5Rs. 20,000/- (Photocopy)

Pack size of ampoule5ml x 5 Rs. 1250/-

TGA approved Venofer – Aspen Pharma Australia

Venofer-RG



326. M/s Star Laboratories (Pvt.) Ltd, 23-km, Multan Road, Lahore


Irosoft Syrup

Each 5ml containsIron (III) hydroxide polymaltose complex eq. to elemental iron 50mg

(Iron preparation) USP specification

17-07-2013Form 5Rs. 20,000/- (Photocopy)

Pack size of ampoule5ml x 5 Rs. 1250/-

TGA approved Maltofer – Aspen Pharma Australia

Ferosoft-Hilton


Approved with change of brand name. Photocopy fee challanswill be verified by Budget & Accounts Division and Chairman Registration Board will permit



327. M/s Pharmix Laboratories (Private) Limited, 21-km, Ferozepur Road, Lahore

Priority # 402

Tablet Pepzym

Each coated tablet containsPancreatin USP 210 FIP P.UMetoclopramide (HCL.2H2O) 6mgBromelain 35000 P.U.Polysiloxane 50mgSodium Dehydrocholate 20mg

(Digestive Enzyme) Manufacture specification

30-09-10 Rs.8000/- Form 530-7-2013 Rs. 12000/- (Photocopy)


Plasil with enzyme – Pacific




Priority # 400

Tablet Vital

Each film coated tablet containsVitamin A (Acetate) USP 5000 I.UVitamin C (Ascorbic Acid) BP 500mgVitamin E USP 200 I.UVitamin D (Cholecalciferol D3) USP 100 I.UFolic Acid BP 200 mcgVitamin B1 (Thiamine mononitrate) USP 15mgVitamin B2 (Riboflavin) USP 15mgZinc BP 40mgCopper BP 2mgManganses BP 1.5mgSelenium BP 40.5mcg

(Vitamins/ minerals) Manufacture specification



Occulovit – Ethical Laboratories


Deferred for confirmation of approval status by reference regulatory authorities, vitamin policy and fee challan


Polyrol Syrup

Each 5ml contains: Iron (III) Hydroxide Polymaltose Complex Eq. to elemental Iron


TGA approved Maltofer-Aspen Pharma, Australia

Ferosoft -

Approved. Photocopy fee challanswill be verified by Budget


Priority # 688………50mg

Iron preparation Manufacture specification


Hilton


& Accounts Division and Chairman Registration Board will permit issuance of registration letter


Priority # 401

Tablet Vitamax

Each tablet containsVitamin A (Acetate) USP 10mgVitamin C (Ascorbic acid) USP 60mgVitamin E USP 30mgVitamin D (Cholecalciferol D3) USP 10 mcgFolic Acid USP 0.400mgVitamin B1 (Thiamine mononitrate) USP 1.50mgVitamin B2 (Riboflavin) USP 1.70mgVitamin B6 (Pyridoxine) USP 2 mgVitamin B12 (Cyanocobalamin) USP 6 mcgNiacin USP 20mgPantothenic acid USP 10mgD-Biotin USP 30 mcgCalcium USP 130mgPhosphorus USP 100mgIodine USP 150 mcgIron USP 18 mgMagnesium USP 100mgCopper USP 2mgZinc USP 15mgPotassium USP 37.50mgMaganese USP 2.50mgChromium USP 10 mcgMolybdenum USP 10 mcgSelenium USP 10 mcgChloride USP 34 mg



Once a Day – CCL


Deferred for confirmation of approval status by reference regulatory authorities, vitamin policy and fee challan


(Digestive Enzyme) Manufacture specification

331. M/s Renacon Pharma (Pvt.) Ltd, 18-km, Ferozpur Road, Opp Nishtar Colony, Lahore

Priority # 1991

Renacit Hemodialysis Concentrate Dry (RCTD)

After mixing and dilution of Part A & Part B by the Haemodialysis machine, the resultant concentrate:-Sodium 140 mmol/LPotassium 2.0 mmol/LCalcium 1.5 mmol/LMagnesium 0.75 mmol/LChloride 109.25 mmol/LCitrate 0.8 mmol/LBicarbonate 35.0 mmol/LGlucose 5.5 mmol/L

Part A:-Sodium 105.0 mmol/LPotassium 2.0 mmol/LCalcium 1.5 mmol/LMagnesium 0.75 mmol/LChloride 109.25 mmol/LCitrate 0.8 mmol/LGlucose 5.5 mmol/LPart B:-Sodium 35 mmol/LBicarbonate 35 mmol/L

(Concentrate for Bicarbonate Hemodialysis) Manufacture specification

19-11-2012Rs.20000/- Form 5(Photocopy)


Renasol – Minntech

License renewed on 21-09-2015.


The international availability provided is different in composition from proposed formulation.

Deferred for re-evaluation and comparison of formulation approved by regulatory authorities of reference countires and fee challan.

332. M/s Pharmacare Labs (Pvt.) Ltd, 129/1 Industrial Estate, Kot Lakhpat, Lahore

Priority # 1463

Pharxime DS Suspension

Each 5ml of reconstituted suspension contains:-Cefixime trihydrate eq to cefixime 200mg

(Cephalosporin) USP specification

27-12-2011Rs.8000/- Form 530-7-2013 Rs. 12000/- (Photocopy)

Pack size & price as per leader brand

FDA Approved brand suprax

Caricef-sami


Approved. Photocopy fee challanswill be verified by Budget & Accounts Division and Chairman Registration


Board will permit issuance of registration letter

333. M/s Pharmacare Labs (Pvt.) Ltd, 129/1 Industrial Estate, Kot Lakhpat, Lahore

Priority # 1461

Tablet Malout

Each tablet contains:-Artemether 80mgLumefantrine 480mg


27-12-2011Rs.8000/- Form 530-7-2013 Rs. 12000/- (Photocopy)



Artem - Hilton



334. M/s Friends Pharma (Pvt.) Ltd, 31-km, Ferozpur Road, Lahore

Priority # 1093

Injection Frendic 75mg

Each 3ml ampoule contains:-Diclofenac sodium 75mg

(NSAID)Manufacture specification

28-5-2011 Rs.8000/- Form 5 14-5-2013 Rs.12000/- (Photocopy)


FDA approved Dycloject – Javelin pharms

Deborn-L (Wellborne)

GMP compliant section 16-02-2016



Priority # 1093

Fledonil Injection

Each ampoule of 5ml contains:- Tranexamic acid 500mg

Anti fibrinolyticManufacture specification

28-5-2011 Rs.8000/- 14-5-2013 Rs.12000/- (Photocopy)


FDA approved Cyclokapron – Pfizer

Brino -Sami


Approved. Photocopy fee challanswill be verified by Budget & Accounts Division and


Chairman Registration Board will permit issuance of registration letter


Priority # 2091

Xylodent Injection

Each ml contains:-Lidocaine HCl 20mgEpinephrine (as tartrate) 10 ug

(Anesthetic agent)USP specification

31-12-2012 Form 5 - Rs. 20000/- Dy # 10383 dated 31-12-2012

Pack size2ml ampoule as per leader brand

FDA approved product

A product of Harmaann, lahore


Approved


Priority # 1096

Phenate Injection

Each 2ml contains:-Phenireamine maleate 45.5mg

(Antihistamine)JP specification

28-5-2011 Rs.8000/- Form 514-5-2013 Rs.12000/- (Photocopy)

Pack size2ml ampoule as per leader brand

Avil-Sanofi, Germany

AVil-sanofi




Priority # 1088

Norobion Injection

Each 3 ml ampoule contains:-Vitamin B1 100mgVitamin B6 100mgVitamin B12 1000mcg

(Vitamin)Manufacture specification

28-5-2011 Rs.8000/- Form 514-5-2013 Rs.12000/-


Neurobion -France

Neurobion - Merck


Approved with change of brand name.


339. M/s Pakistan Pharmaceutical Products (Pvt.) Ltd, D-122, S.I.T.E, Karachi

Priority # 1002

Tablet Vastec 20mg

Each film coated tablet contains:-Rosuvastatin (As calcium) 20mg

(Lipid regulating drug)Manufacture specification

23-04-2011 Dy.No.986 Form 5Rs.8000/- (Photocopy)Rs.12,000/- 31-07-2013


MHRA approved crestor - Astrazeneca

Amro- Amarant




Priority # 1021

Tablet Candia 32mg

Each tablet contains:-Candesartan Cilexetil 32mg

(Anti hypertensive )Manufacture specification

23-04-2011 Dy.No.986 Form 5Rs.8000/- (Photocopy)Rs.12,000/- 31-07-2013


MHRA approved Amias – Takeda

Carac - Wilshire




Priority # 1018

Tablet Candia 4mg

Each tablet contains:-Candesartan Cilexetil 4mg

(Anti hypertensive )Manufacture specification

30-04-2011 Dy.No.1057 Form 5 Rs.8000/- (Photocopy)Rs.12,000/- 31-07-2013


MHRA approved Amias – Takeda

Carac - Wilshire


Approved. Photocopy fee challanswill be verified by Budget & Accounts Division and Chairman Registration Board will permit




Priority # 1020

Tablet Zolot 75 mg

Each film coated tablet contains:-Clopidogrel (as Hydrogen Sulphate) 75mg

(Antiplatelet)USP specification

30-04-2011 Dy.No.1061 Form 5 Rs.8000/- (Photocopy)Rs.12,000/- 31-07-2013


MHRA approved brand of Accord

Lowplat -Pharmevo




Priority # 1019

Tablet Alfa-one

Each tablet contains:-Alfacalcidol 0.5 ug

(Vitamin D analogue)USP specification

30-04-2011 Dy.No.1056 form 5Rs.8000/- (Photocopy)Rs.12,000/- 31-07-2013


Alfa-D (Platinum)




Priority # 1530

Zinkid 20mg / 5ml Syrup

Each 5ml contains: Elemental Zinc as zinc sulphate monohydratre..……20 mg

(Mineral Supplement) USP specification

30-04-2011 Dy.No.1056 form 5Rs.8000/- (Photocopy)Rs.12,000/- 31-07-2013



Kilin -LinearGMP compliant section vide inspection report dated 31-12-2015

Product under review as waiting for reply of WHO.

Deferred as product is under review and sent for views of WHO.


345. M/s Highnoon Laboratories Ltd, 17.5 km , Multan Road, Lahore

Priority # 2629

Tablet Ivahi 7.5mg

Each film coated tablet contains: Ivabradine HCl eq to Ivabradine 7.5mg

(Anti angina ) USP specification

04-11-2013 form 5-DRs.50000/- (Photocopy)

Pack size 10s Rs. 2500/-20s Rs. 5000/-

MHRA approved Procoralan – Servier



Deferred for provison of stability data as per guidelines provided in 251st RB meeting and fee challan.

346. M/s Highnoon Laboratories Ltd, 17.5 km , Multan Road, Lahore

Priority # 2628

Tablet Ivahi 5mg

Each film coated tablet contains: Ivabradine HCl eq to Ivabradine 5mg

(Anti angina ) USP specification

04-11-2013 form 5-DRs.50000/- (Photocopy)

Pack size 10s Rs. 1500/-20s Rs. 3000/-



Deferred for provision of stability data required as per guidelines provided in 251st RB meeting and fee challan.

347. M/s Life Pharmaceutical company, 24-III Industrial Estate Multan

Priority # 1992

Caliz Dry suspension

Each 5ml of reconstituted suspension contains: Azithromycin Dihydrate eq to Azithromycin 200mg

(Antibiotics ) USP specification

20-11-2012 Form 520000/- (Photocopy)

Pack size 15ml Rs. 300/-25 ml Rs. 480/-


Azomax – Novartis



348. M/s Swiss Pharmaceuticals (Pvt.) Ltd, A/159, S.I.T.E, Super Highway, Karachi

Priority # 810

Tablet Desotin 5mg

Each film coated tablet contains: Desloratadine 5mg

(Antihistamine) Manufacture specification

11-01-2011 Dy.No.90 Form 5 Rs.12,000/- 05-02-2013 (Photocopy)

Pack size 10s as per PRC

MHRA approved brand of Consilient

Alenor – Macter


Approved. Photocopy fee challanswill be verified by Budget & Accounts Division and


inspection report dated 31-08-2015

Chairman Registration Board will permit issuance of registration letter


Priority # 803

Tablet Alfadol 1mcg

Each tablet contains: Alfacalcidol 1.0 mcg

(Vitamin D Analogue) Manufacture specification



Adela - getz




Priority # 1060

Spasno 40mg Injection Each 4ml contains:- Hydrated Phloroglucinol.40mg Trimethylphloroglucinol 0.04mg

(Anti Spasmodic) Manufacture Specification



Spasfon –France

Spasfon –Himont



Deferred as product is under review and fee challan


Priority # 806

Laxolac 3.35gm Syrup Each 5ml contains:- Lactulose USP 3.35gm

(osmotic lexative) USP Specification



MHRA. Duphalac 3.35g/5ml By M/s BGP

Local. Duphalac 3.35g/5ml by M/s Highnoon


Source of Lactulose required along with fee and documents.

Deferred for Source of lactulose, fee, GMP, stability data, fee challan.




Priority # 975

Tablet Lufid 20mg Each film coated tablet contains:- Leflunomide 20mg

(Anti rheumatic) USP Specification


Pack size of 30s as per SRO

MHRA.Arava-Sanofi

Adira - Wilshire



353. ] M/s Swiss Pharmaceuticals (Pvt.) Ltd, A/159, S.I.T.E, Super Highway, Karachi

Priority # 1030

Ironate 800mg/15ml Syrup Each 15ml contains:- Iron Protein Succinylate 800mg eq to elemental iron 40mg

(Anti anemic) USP Specification



EMICO-NOA HEMIS




Priority # 1101

Tablet CartiPLUS Each film coated tablet contains:- Glucosamine Sulphate 750mgChondroitin Sulphate 600mg

(Musculo-skeletal product) Manufacture Specification



Cartigen plus – Getz


Me too needs confirmation




Priority # 217

Injection Cefot 2gm Each vial contains:- Cefoperazone Sodium USP eq to Cefoperazone 1gmSalbactam sodium eq to salbactam 1 gm


11-01-2011 Dy.No.89 Form 5Rs.12,000/- 05-02-2013 (Photocopy)


Cebac -Bosch




Priority # 968

Tablet Rapral 10mg

Each enteric coated tablet contains:- Rabeprazole (as sodium) 10mg

(Proton Pump Inhibitor) Manufacture Specification

12-04-2011 Dy.No.885 Form 5 Rs.8000/- Rs.12,000/- 05-02-2013 (Photocopy)


MHRA approved Pariet – Eisai

Rabecid -Highnoon





Tablet Swiss Mether 40/240

Each tablet contains:- Artemether 40mgLumefantrine 240mg

(antimalarial) Manufacture Specification


Pack size of 1 x 16s as per SRO


Artem -Hilton


Approved. Photocopy fee challanswill be verified by Budget & Accounts Division and Chairman Registration Board will permit issuance of


registration letter



Tablet Swiss Mether 80/480

Each tablet contains:- Artemether 80mgLumefantrine 480mg

(antimalarial) Manufacture Specification


Pack size of 1 x 6s as per SRO


Artem -Hilton



359. M/s Amarant Pharmaceuticals (Pct.) Ltd, 158-D, Tora Gadap Road, Super Highway, Karachi

Priority # 1926

Amate 7.5mg Tablet

Each film coated tablet contains: Calcium 1-5-methyltetrahydrofolate eq. to 1- methylfolate….7.5 mg

(Adjunctive use in major depressive and schizophrenia)

19-10-2012Dy.No.1305 Form 5-DRs.20,000/-(Photocopy)


Tablet L-Methylfolate 7.5mg – Virtus Pharmaceuticals, USA


Firm needs to submit remaining fee for prescribed Form 5-D.

Firm needs to submit stability data as per guidelines provided in 251st

RB meeting.

Deferred for Remaini

ng fee for prescribed Form 5-D.

Stability data as per guidelines provided in 251st

RB meeting.

Fee challan

360. M/s Amarant Pharmaceuticals (Pct.) Ltd, 158-D, Tora Gadap Road, Super Highway, Karachi

Priority # 1927

Amate 15mg Tablet

Each film coated tablet contains: Calcium 1-5-methyltetrahydrofolate eq. to 1- methylfolate….15 mg

19-10-2012Dy.No.1306 Form 5-DRs.20,000/-(Photocopy)


Tablet L-Methylfolate 15mg – Virtus Pharmaceuticals, USA


Firm needs to submit remaining fee for prescribed Form 5-D.

Deferred for Remaini

ng fee for prescribed Form 5-D.

Stability


(Adjunctive use in major depressive and schizophrenia)


Firm needs to submit stability data as per guidelines provided in 251st

RB meeting.

data as per guidelines provided in 251st

RB meeting.

Fee challan

361. M/s Linear Pharma, Plot # 18, Street S-4, National Industrial Zone, Rawat.

Priority # 485

Tablet Betalin 16mg

Each tablet contains: Betahistine 16mg

AntihistamineManufacture Specification

17-12-2013Rs. 12000/-Dy.No.846Form 502-11-2010Rs.12,000/-


MHRA approved brand of Aurobindo.

Serc-Abbott

Inspection report dated 19-01-2016

Approved


Priority # 484

Tablet Betalin 8mg

Each tablet contains: Betahistine 8mg


17-12-2013Rs. 12000/-Dy.No.8140Form 502-11-2010Rs.12,000/-


MHRA approved brand of Aurobindo.

Serc-Abbott


Approved


Priority # 513

Tablet Linakast 10mg

Each film coated tablet contains: Montelukast (as sodium) 10mg


17-12-2013Rs. 12000/-Dy.No.8133Form 502-11-2010Rs.12,000/-


MHRA approved brand of Accord

Serc-Abbott

Approved


Tablet Heam 500 mcg

Each sugar coated tablet contains: Mecobalamin 500 mcg

Vitamin

17-12-2013Rs. 12000/-Dy.No.8147Form 506-10-2010Rs.12,000/-

Methycobal – Eisai, Japan

Anemovit - Pharmacare

Approved


Priority # 484 Manufacture Specification Pack size & price

as per SRO365. M/s Linear

Pharma, Plot # 18, Street S-4, National Industrial Zone, Rawat.

Priority # 515

Tablet Melix 15mg

Each uncoated tablet contains: Meloxicam USP 15mg


17-12-2013Rs. 12000/-Dy.No.8136Form 506-10-2010Rs.12,000/-


USFDA MOBIC - Boehringer

ALOXI - ALSON

Approved


Priority # 514

Tablet Melix

Each uncoated tablet contains: Meloxicam USP 7.5mg


17-12-2013Rs. 12000/-Dy.No.8138Form 506-10-2010Rs.12,000/-


USFDA MOBIC - Boehringer

ALOXI - ALSON

Approved


Priority # 483

Tablet Liprazole 15mg

Each oro-dispersible tablet contains: Aripiprazole 15mg

Dopamine Partial agonistPsychotic drugManufacture Specification

17-12-2013Rs. 12000/-Dy.No.8138Form 506-10-2010Rs.12,000/-


MHRA approved Abilify – Otsuka

Zedan -Surge

Proof of segregated facility for psychotropic manufacturing not provided.

Approved

368. M/s Reko Pharmacal (Pvt.) Ltd, 13th km, Multan Road, Lahore

Priority # 2850

Epafen Ophthalmic Solution

Each ml contains: Nepafenac 1mg

Anti inflammatoryManufacture Specification

30-12-2013Rs. 20,000/-Dy.No. 1424Form 5


MHRA approved Nevanac- Alcon

Fenap –Valor

GMP Compliant section vide inspection report dated 30-03-2016

Approved


369. M/s Reko Pharmacal (Pvt.) Ltd, 13th km, Multan Road, Lahore

Priority # 2849

Olopine Ophthalmic Drops

Each ml contains: Olopatadine (as HCl) USP 2mg

Anti inflammatoryManufacture Specification

30-12-2013Rs. 20,000/-Dy.No. 1423Form 5


FDA approved Pataday- Alcon

Aptadine -Barrett

Approved

370. M/s Genome Pharmaceuticals (Pvt.) Ltd, 16/1, Phase IV, Industrial Estate, Hattar, Haripur

Priority # 2343

Ranast 112.5mg Capsules

Each capsule contains:- Pranlukast (as hemihydrate) 112.5mg

(cysteinyl leukotriene receptor-1 antagonist)Manufacture specification

31-05-2013Rs. 20,000/-Dy.No. 471Form 5

Pack size & price as per pRC

Proof of approval status of same dosage form in reference countries and Pakistan not provided.


371. M/s Apex Pharmaceuticals (Pvt.) Ltd, D-21, A/1, S.I.T.E, Super Highway, Karachi

Priority # 42

Apdinir Suspension 50mg/5ml

Each 5ml of reconstituted suspension contains:- Cefdinir 50mg

(Antibiotics)Manufacture specification

10-06-2010 Dy # 1158 Form 5Rs.8000/- Rs.12,000/- 28-03-2014 Photocopy

Pack size of 60ml & price as per pRC

Zaply- Wislhire

Following documents not found in application Latest


Proof of approval status of same dosage form in reference countries and PAKISTAN.

Commitment as per decision

Deferred for Latest


confirmation of approval status by reference regulatory authorities and Pakistan .


RB meeting.


of 251st

RB meeting.

Fee challan


Priority # 39

Danvar capsule

Each capsule contains:- Cefaclor (as monohydrate) USP 500mg

(Antibiotics)USP specification



MHRA approved Distaclor -Flynn

Ceclor -AGP




RB meeting.

Deferred for Latest



RB meeting.

Fee challan


Priority # 33

Apedroxile capsule

Each capsule contains:- Cefadroxil (as monohydrate) USP 500mg

(Antibiotics)USP specification




Neucef - Sami




RB meeting.

Deferred for Latest



RB meeting.

Fee challan


374. M/s Davis Pharmaceuticals Laboratories, 121, Industrial Triangle Area, Kahuta Road, Islamabad.

Priority # 1228

Tricold plus Sachet

Each Sachet Contains Paracetamol 500mgMepyramine Maleate 13mgPheniramine maleate 13mgPseudoephedrine HCl 30mg

Analgesic / Anti allergicManufacture Specification

30-07-2011 Form 5Rs.8000/- Rs.12,000/- 30-07-2013


Flu Eze - Werrick




RB meeting.


Deferred for Latest


Proof of approval status of same dosage form in reference countries and PAKISTAN.


RB meeting.

375. M/s Davis Pharmaceuticals Laboratories, 121, Industrial Triangle Area, Kahuta Road, Islamabad.

Priority # 1228

Tricold plus Sachet

Each Sachet Contains Paracetamol 500mgMepyramine Maleate 13mgPheniramine maleate 13mgPseudoephedrine HCl 30mg

Analgesic / Anti allergicManufacture Specification

30-07-2011 Form 5Rs.8000/- Rs.12,000/- 30-07-2013


Flu Eze - Werrick




RB meeting.

Deferred for Latest


Confirmation of approval status by reference regulatory authorities and



Pakistan .


RB meeting.

376. M/s Getz Pharma (Pvt.) Ltd, 29-30, Sector 27, Korangi Industrial Area, Karachi

Priority # 1102

Daxin 30mg Tablet

Each film coated tablet contains: Dapoxetine Hydrochloride eq. to Dapoxetine…………..30 mg (SSRI)

30-07-2011 Form 5Rs.8000/- Rs.12,000/- 30-07-2013


priligy Approval status of dosage form in Pakistan not provided.

Deferred for application on Form5D as it is not registered in Pakistan

377. M/s Allmed Pvt.Ltd.(Formerly,EverGreenPharmaceuticals,Pvt. Ltd.Plot.No.590,Sundar IndustrialEstate Lahore.Priorty # 196

Calso TabletEach tablet contains: Calcium Acetate B.P ….667mg eq.to Elemental Calcium 169mgCalcium Supplement(Manfacturer’s Specs)

28-07-2010Form 5Rs.8000/- Rs.12,000/- 30-07-2013

Pack size 10x10’s as per PRC

Phoslo by M/s Nabi-BioPharmaceutical USA

Lophos by M/s Getz Pharma

Approved

378. M/s Allmed Pvt.Ltd.(Formerly,EverGreenPharmaceuticals,Pvt. Ltd.Plot.No.590,Sundar IndustrialEstate Lahore.Priorty # 195

EverpolInfusionEach 100ml contains: Paracetamol B.P…..1gAnalgesic / Antipytic (Manfacturer’s Specs)

28-07-2010Form 5Rs.8000/- Rs.12,000/- 30-07-2013

Pack size 1’sx100ml as per PRC

Perfalgan by M/s B-Braun Germany

Falgan by M/s Bosch Pharma

Approved

379. M/s Indus Pharma Karachi.Priorty # 1197

ParazolTabletEach tablet contains: Paracetamol…..500mgAnalgesic / Antipytic

25-06-2011Form 5Rs.8000/- Rs.12,000/- 06-06-2013

Pack size 20’s Rs.200/-

Paracetamol by M/s Johnsan & Johnsan Canada Panadol by M/s GSK

Approved



Veterinary Routine cases :-

S/N

Name and address of manufacturer / Applicant

Brand Name


Composition



Type of Form

Initial date, diary




Me-too status



Decision

380. M/s Star Laboratories, 23-km, Multan Road, Ghung, Lahore

Priority # 371

Toltrastar Oral Solution

Each ml containsToltrazuril (I.H.S) 25 mg


18-06-2013Dy.No.708 Form 5Rs.20.000/-

Pack size of 100ml, 150ml, 500ml & 1000ml decontrolled

Emicide - nawal


Approved


Priority # 372

Tilmisin Oral Solution

Each ml containsTilmicosin (as phosphate) USP 250mg


18-06-2013Dy.No.705 Form 5Rs.20.000/-

Pack size of 100ml, 150ml, 500ml & 1000ml decontrolled

Motil - Breeze


Approved



Priority # 372

Closan 500mg Bolus

Each bolus containsClonastel (as Sodium) 500mg

Anthelmintic Manufacture Specification

19-04-2013Dy.No.334 Form 5Rs.20.000/-

Pack size of Glass bottle decontrolled

Flukinil - Selmore


Approved


Priority # 372

Cipvet-200 injection

Each ml containsCiprofloxacin BP 200mg

Antibiotics Manufacture Specification

31-01-2014Dy.No.101 Form 5Rs.20.000/-

Pack size of Glass bottle 50m decontrolled

Floxacin - Leads


To follow policy decision on this veterinary formulation.

Rejected

The Board also advised to issue show cause to the companies with registered ciprofloxacin.


Priority # 378

Leva 20% Oral Powder

Each gram containsLevamisole HCl BP 200mg

AnthelmenticsManufacture Specification

04-07-2013Dy.No.792 Form 5Rs.20.000/-

Pack size of 100gm, 500gm, 1000gm & 2.5kg

Levabak - Attabak


Approved


Priority # 369

Florfenic Oral Solution

Each ml containsFlorfenicol 100mg


18-06-2013Dy.No.210 Form 5-DRs.50.000/-

Pack size of 100ml, 150ml, 250ml, 450ml, 1 litre

Florobak - Attabak


Firm applied on Form 5-D but now product is me too and accordingly firm has submitted Form 5.

Approved



Priority # 367

Tablet Carpropain

Each chewable tablet containsCarprofen USP 50mg

NSAIDUSP Specification

08-06-2013Dy.No.706 Form 5-DRs.50.000/-

Pack size decontrolled

FDA approved Rimadyl chewable tablet – Zoetis USA


Stability studies required as it is a new molecule to be registered in Pakistan.

Deferred for provision of stability studies as per guidelines approved in 251st

meeting.


Priority # 369

Tablet Prazistar

Each film coated tablet containsPyraziquantel BP 20mgPyrantel Pamoate BP 230mg

AntheminticManufacture Specification

18-06-2013Dy.No.706 Form 5-DRs.50.000/-


Cazitel 230/20 falvoured film coated tablet – Chanelle Pharmaceuticals, Ireland

Drontal –Bayer-UK




meeting.


Priority # 366

Tablet Prazistar plus

Each film coated tablet containsPyraziquantel BP 50mgPyrantel Pamoate BP 144mgFebantel BP 150mg


18-06-2013Dy.No.711 Form 5-DRs.50.000/-


Well plus flavoured tablet – Divasa Spain

Drontal plus flavoured tablet – Bayer-UK




meeting.


Diclavet Oral Solution

Each 100 ml containsDiclazuril BP 1gm


18-06-2013Dy.No.711 Form 5-DRs.50.000/-



Product in proposed strength doesn’t exist in Pakistan and reference

Deferred for confirmation of approval status of same formulation by reference


Priority # 370

countries. regulatory authorities and Pakistan.


Priority # 380

Bamberstar Powder

Each 100 gm containsBambermycin 4gm

AntbioticsManufacture Specification

18-06-2013Dy.No.801 Form 5-DRs.50.000/-


Flavomycin – Intervet-USA



Deferred for provion of stability studies as per guidelines provided in 251st RB meeting.


Priority # 379

Wormflash Deworming Capsules

Each capsule containsPiperazine Citrate BP 390mg

AnthelminticManufacture Specification

18-06-2013Dy.No.800 Form 5-DRs.50.000/-



Product in proposed strength doesn’t exist in Pakistan and reference countries.

Deferred for confirmation of approval status of same formulation by reference regulatory authorities and Pakistan.


Priority # 381

Micostar medicated shampoo

Each 100ml containsMiconazole Nitrate BP 2gmChlorhexidine Gluconate BP 2gm

Antimicrobial Manufacture Specification

18-06-2013Dy.No.802Form 5-DRs.50.000/-


Malaseb – Bayer -UK



Deferred for provion of stability studies as per guidelines provided in 251st RB meeting.


Priority # 381

Doxygenta Powder

Each gram containsDoxycycline Hyclate BP 100mgGentamicin Sulphate USP 50mg

Antibacterial Manufacture

18-06-2013Dy.No.803Form 5-DRs.50.000/-


Gentadox 10/5, Agrar Holland, The Netherland


Stability studies required as it is a new formulation to be registered in Pakistan. .

Deferred for provion of stability studies as per guidelines provided in 251st RB meeting..


Specification

394. M/s Inshall Pharmaceutical Industries, Plot # 2, Street SS2, RCCI Industrial area, Rawat Islamabad.

Priority # 384

Hepasoul LiquidEach 100ml containsL.Cartinine……5%Magnesium Sulphate. USP…….1%Sorbitol…………20%Choline Chloride BP….10%Betain……….2%Inositol BP………..0.7%Hepatoprotective, (Multivitamins. Immune booster )

10-07-2013Dy.No.4234Form-5Rs.20,000/-

Pack size 100ml,150ml,250ml,500ml,1Liter,2.5Liter decontrolled

Heptic Solution by M/s Evergreen Pharma LahoreReg#072689


Approved

395. M/s Inshall Pharmaceutical Industries, Plot # 2, Street SS2, RCCI Industrial area, Rawat Islamabad.

Priority # 384

Coolant PowderEach 1000 g containsVitamin C……………200gAcetyl Salicylic Acid….67gCalcium Carbonate…...50gSodium Chloride……40gMagnesium Sulphate….40gSodium citrate……0.7g(NSAID)

10-07-2013Dy.No.4235Form-5Rs.20,000/-

Pack size 30g,50g,100g,250g,500g,1kg,5kg,10kg,25kgdecontrolled

Acelyte water Soluble Powder by M/s Decent Pharma Rawat Reg#079821


Approved



Deferred cases :-

S.No.

Name and address of manufacturer / Applicant



Approval status international / national

Decision of meeting of Registration Board

Remarks Decision

396. M/s Novartis Pharma (Pakistan) Limited, Petaro Road, Jomshoro.

Nocid 40mg/5ml

Each 5 ml of reconstituted suspension contains Famotidine BP 40mg

Histamine H2 receptor antagonist


Form 5Rs. 20,000/- vide Dy. No. 2629 dated 11-12-2015

Pack size of 60ml amber color glass bottle

Famotidine 40mg/5ml –FDA

Zepsin (Cirin)

Registration Board in its 257th

meeting deferred for evaluation as per decision of 250th Registration Board meeting.

Firm has submitted the prescribed fee Rs. 20,000/- on 14-06-2016, for form 5.

Approved

397. M/s CCL Pharmaceutical Lahore.

Sita-Met XR Tab 50/500 Tablet Each tablet contains:Sitagliptin phosphate monohydrate eq. to Sitagliptin….................50mgMetformin HCI………..500mg(Anti Diabetic)

Priority 2252

Form-5-DDy. No: Not mentionedDated.08-04-2013Rs.50,000/-As per SRO10’s,14’s,30’s USFDA Approved.JANUMET XRBy MERCK SHARP DOHME

Deferred 257th for clarification of NCE as per DRAP’s Policy Board decision

Firm has submitted Stability Studies conducted as per decision of 251st

meeting of the Board.

Registration Board referred for on site verification of stability data by panel comprising of Director DTL, Peshawar, Lahore and area FID, DRAP.


398. M/s CCL Pharmaceutical Lahore

Sita-Met XR Tab 50/1000 Tablet Each tablet contains:Sitagliptin phosphate monohydrate eq. to Sitagliptin….................50mgMetformin HCI……..…..1000mg(Anti Diabetic)

Priority 2251

Form-5-DDy. No: Not mentionedDated.08-04-2013Rs.50,000/-As per SRO10’s,14’s USFDA Approved.JANUMET XRBy MERCK SHARP DOHME






Sita-Met XR Tab 100/1000 Tablet Each tablet contains:Sitagliptin phosphate monohydrate eq. to Sitagliptin….................100mgMetformin HCI……..…..1000mg(Anti Diabetic)

Priority 2253

Form-5-DDy. No: Not mentionedDated.08-04-2013Rs.50,000/-As per SRO10’s,14’s USFDA Approved.JANUMET XRBy MERCK SHARP DOHME






Urocon + TabletsTablet Each tablet contains:Solifenacin succinate ……….6mg Tamsulosin HCl (as SR pellets)…..0.4mg(Alpha-1

Form-5-DDy. No: Not mentionedDated.03-12-2013Rs.50,000/-As per SRO30’s Vesomni (UK), MHRA


Registration Board referred for on site verification of stability data by panel comprising of Director DTL,


adrenoceptor antagonists) Priority 2745

Peshawar, Lahore and area FID, DRAP.

401. M/s Elko Organization (Private) Limited, 27 & 28, Sector 12/B, North Karachi, Industrial Area, Karachi

Priority # 359

Carbo Vet Injection

Each ml contains:-Carbetocin………..0.07mg/ml

Oxytocic, antihemorrhagic and uterotonic drugBP Spec’s

Form 5-D vide Dy. # 2670 dated 24-05-2013

Pack size –10ml, 50ml, 100ml, - Decontrolled

Registration Board in 258th RB meeting deferred the case and advised to apply on prescribed Form 5-D along with required documents because same formulation is not yet registered in Pakistan.

Firm has now submitted application on prescribed Form 5-D in which following shortcomings needs to be rectified :- Stability data

of the product as per guidelines provided in 251st RB meeting.

Prescribed fee of Form 5-D.

Deferred for provision of following information/documents Stability

data of the product as per guidelines provided in 251st

RB meeting.


402. M/s Elko Organization (Private) Limited, 27 & 28, Sector 12/B, North Karachi, Industrial Area, Karachi

Priority # 361

Gamocin Injection

Each ml contains:- Gamithromycin… ……..150mg/ml

(Antibioric).

Form 5-D vide Dy. # 2669 dated 24-05-2013

Pack size –10ml, 50ml, 100ml, 250ml, 500ml, 1000ml vials Decontrolled

Registration Board in 258th RB meeting deferred the case and advised to apply on prescribed Form 5-D along with required documents because same formulation is not yet registered in Pakistan.

Firm has now submitted application on prescribed Form 5-D in which following shortcomings needs to be rectified :- Stability data

of the product as per guidelines provided in 251st RB meeting.


Deferred for provision of following information/documents Stability

data of the product as per guidelines provided in 251st

RB meeting.


403. M/s UDL Pharmaceuticals, Plot # E-44& E-

TENZOLID 100mg/5ml granulesfor oral

Form 520,000/- Dy. No. 4278 (07/07/2015)

RegistrationBoarddeferred thecase in 258th

Photocopies of COA , GMP certificate.

Approved. Firm will provide legalized


https://en.wikipedia.org/wiki/Uterotonic

https://en.wikipedia.org/wiki/Uterotonic

https://en.wikipedia.org/wiki/Antihemorrhagic

https://en.wikipedia.org/wiki/Antihemorrhagic

https://en.wikipedia.org/wiki/Oxytocic

45, North Western Industrial Zone, Port Qasim Authority, Karachi.

suspension

Each 5ml ofreconstitutedsuspension contains:Linezolid BP 100 mg

(Antibiotics)USP Specification

Source of pellets:-Benovo Labs private limited, Plot # 97 & 98, Kolhar Industrial Area, Bidar, Karnatka, India

Pellet fee Rs. 80,000/- vide Dy # nil dated 24-05-2016

Pack of 10’s and 30’s as per SRO

FDA approved Avodart (GSK)

Avodart (GSK)

meeting of RB forprovision ofSource ofcoated tastemaskedlinezolidpellets alongwith GMPcertificate ofthe source,Stability dataand requiredfee if sourceis outside ofPakistan.

GMP, CoA, stability data of Zone IVA and Chairman, RB will permit issunce of registration letter.

404. M/s Uniferoz PVT. Ltd. 32/8 Sector 15, Korangi Industrial Area, Karachi.(1840)

Saniplast Aqua Bandage First Aid Bandage

Each Bandage contains:Polyurethane (PU) Tape Bezalkonium Chloride Pad ………………..0.5%w/w.

(First Aid Bandage)(Mfg. specs)

Form-5Dy. No: 1442 Dated. 21.06.2012Rs.8,000/-Dated.05.09.2013Rs.12000/-Rs.41/10’s (25x72mm),40.50/10’s (38x38mm)40.57/10’s, (5’s x25x72mm & 5’sx38x38mm)40.57/20’s, (10’s x25x72mm & 10’s x38x38mm)

BAND-AID (Johnson & Johnson) made in Brazile, distributed in canada.Nexcare Clear by 3M consumer Health Care USA.Saniplast Ultra first aid Bandage (with

Deferred in 257th RB meeting for clarification for registration of the same strength / composition.

Reply of the firm mentioned below

Approved


Poluethylene Base) by M/sUniferoz.

It is water proof bandage, thus the wound area is protected from getting wet. It completely seals the applied area on the skin and help protect the small wound from dust and germs. The consumer will appreciate availability of this new improved variant once it is available in Pakistan,

as this is available abroad, and they do purchase this vairiant abroad. Introduction of this variant will help in introducing this new improved first aid bandages for domestic

and export markets, improve utilization of our capacity and adapt modern technology.

They further explained that Board has already granted export registration of saniplast aqua bandage. However when we apply for registration abroad they require free sale certificate in the country of manufacturer, which they couldn’t provide to importing country due to non-registration in Pakistan.

405. -do- Dermapore NonWoven FabricSurgical Tape for(SurgicalDressing &Bandage)

Form 510 cmx10m5 cm x 10m2.5 cm x10Demanded pricehas not beenmentionedRs.8000/-(27/07/2010)Rs.12,000/-(23/07/2013)Fee challans areduplicateTotalRs.20,000/-Dy. No. notavailable /Duplicatedossier

GMPinspectionreport dated15-07-2014.Overall GMPcompliancelevel rated asgood.

Deferred for the confirmation of approval status in reference countries.

Reply of the firm mentioned below

We already manufacture Dermapore Non Woven Paper Surgical Tapes for domestic and export markets and has registration from DRAP. Non-Woven fabric surgical tapes would be manufactured by using the same manufacturing capacity to introduce a new varient.

Dermapore Non Woven Fabric Surgical tapes export registration was granted by board earlier, now we are seeking registration to sell the same product in domestic market for utilization of capacity and modern technology.

For export registrations in foreign countries we required free sale certificate which can only be applied when we have local registration.

Non registered similar tapes are already being used in local hospitals. We on the other hand are seeking registration to manufacture a better product locally by utilizing our hand are seeking

Registration Board referred the proposed product for comments of ECMD.


registration to manufacture a better product locally by utilizing our ideal capacity, and meeting the demand of the market.

406. ImporterM/s. UM Enterprises, Karachi, 18-C, 3rd

floor, Dolmen Estate Building, Block 7-8, Shaheed-e-Millat Road, Karachi

Manufacturer:M/s. Arab Veterniary Industries CO, (AVICO), P.O Box 150906 Amman, 11115, Jordan

Gentadox Water Soluble powder

Each gm contains:-Gentamycin Sulphate 160mg equivalent to Gentamycin 100mgDoxycycline HCl 100mg

Antibiotic Specifications:- Manufacturer

Form 5 with fee Rs 100,000/- vide Dy. # 411 dated 13-05-2013

Pack size of 100gm, 500gm, 1kg & 5kg decontrolled

Zygosis-NigeriaJovet-Jordan

Not yet registered in Pakistan

The Board deferred the case for provision of approval status of same formulation in Pakistan and reference regulatory authorities.

Registration Board rejected the proposed formulation, being ir-rational.

407. ImporterM/s. UM Enterprises, Karachi, 18-C, 3rd

floor, Dolmen Estate Building, Block 7-8,

Diclacox Liquid

Each ml contains:-Diclazuril 10mg

AnticoccidalSpecifications:- Manufacturer


Pack size of 100ml, 500ml, 1L & 5L decontrolled

however in powder from available.

The Board deferred the case for provision of approval status of same dosage form in reference regulatory authorities and in Pakistan.

Registration Board deferred the case for provision of following documents/information:- Product

Development data in liquid dosage


Shaheed-e-Millat Road, Karachi

Manufacturer:M/s. Arab Veterniary Industries CO, (AVICO), P.O Box 150906 Amman, 11115, Jordan

Reg # 021258 form. Stability

data for real time studies and accelerated time studies.

Complete master formulation along with active and inactive ingrdients.

Deferred cases of new licensed manufacturers

408. M/s Linta Pharmaceuticals (Pvt.) Ltd, Plot # 3, Street # S-5, National Industrial Zone, Rawat

Ospra capsule 20mg

Each CapsuleContains: Omeprazole(enteric coated pellets) eq. to Omeprazole... 20mg

(Proton PumpInhibitor)(USP Spec.s)

{Source of pellets: M/s . Lee Pharma Ltd., Sy. No. 199, Plot No. 3 & 4, D.No. 5-9-265/1 & 2, Rajeevgandhinagar, Prasanthinagar I.E, Kukatpally, Ranga Reddy District, Telangana State, India}

Form 517-04-2015(977)Rs.1,00,000/-As per SRO/2 x 7’s

BNF: Losec(AstraZeneca)

RISEK 20mg CapsuleGetz Pharma (Pvt.)Ltd

Grant For registration of drugs of new license dated 02-04-2015

Deferred in 249th RB meeting for submission of legalized GMP certificate of pellet’s manufacturer, COA and stability studies data of pellets.

Firm has now change the source of pellets and submitted new source documents as under:-Source of Omeprazole ECP pellets 22.5%:-M/s Vision Pharmaceuticals, Plot # 22-23, Industrial Triangle, Kahuta Road, Islamabad.

Approved


409. -do- Ospra capsule 40mg

Each CapsuleContains: Omeprazole(enteric coated pellets) eq. to Omeprazole... 40mg




BNF: Losec(AstraZeneca)

RISEK 40mg CapsuleGetz Pharma (Pvt.)Ltd



Firm has now change the source of pellets and submitted new source documents as under:-Source of Omeprazole ECP pellets 22.5%:-M/s Vision Pharmaceuticals, Plot # 22-23, Industrial Triangle, Kahuta Road, Islamabad.

Approved

410. -do- Rush capsule 20mg

Each CapsuleContains:-Esomeprazole( asEsomeprazole magnesium trihydrate entericcoated pellets) (USP)…20 mg




NEXIUM Capsule(AstraZeneca)

E-CAP 40mg Capsules((Brookes Pharmaceuticals (Pvt) Limited))


Deferred in 249th RB meeting for submission of legalized GMP certificate of pellet’s manufacturer, COA and stability studies data of pellets as per Zone IVA.

Firm has now change the source of pellets and submitted new source documents as under:-Source of Esomeprazole Mg ECP pellets 22.5%:-M/s Vision Pharmaceuticals, Plot # 22-23, Industrial Triangle, Kahuta Road, Islamabad.



411. -do- Rush capsule 40mg

Each CapsulecontainsEsomeprazole( asEsomeprazole magnesium trihydrate entericcoated pellets) eq. toEsomeprazole…40 mg




NEXIUM Capsule(AstraZeneca)

E-CAP 40mg Capsules(Brookes Pharmaceuticals (Pvt) Limited)


Deferred in 249th RB meeting for submission of legalized GMP certificate of pellet’s manufacturer, COA and stability studies data of pellets as per Zone IVA.

Firm has now change the source of pellets and submitted new source documents as under:-Source of Esomeprazole Mg ECP pellets 22.5%:-M/s Vision Pharmaceuticals, Plot # 22-23, Industrial Triangle, Kahuta Road, Islamabad.


412. -do- Votsa capsule 30mg

Each CapsuleContains: Lansoprazole(enteric coated pellets) eq. to Lansoprazole (USP) ... 30mg

(Proton PumpInhibitor)(USP Spec.s){Source of pellets: M/s . Lee Pharma Ltd., Sy. No. 199, Plot No. 3 & 4, D.No. 5-9-265/1 & 2, Rajeevgandhinagar, Prasanthinagar I.E, Kukatpally, Ranga Reddy District, Telangana State, India}


FDA: Prevacid(Novartis Pharmaceuticals)

Inhibitol 30mg Capsule(Highnoon Laboratories Limited)



Firm has now change the source of pellets and submitted new source documents as under:-Source of Lansoprazole ECP pellets 22.5%:-M/s Vision Pharmaceuticals, Plot # 22-23, Industrial Triangle, Kahuta Road, Islamabad.

Approved

413. M/s Hamaz Pharmac

Montilak 4mg sachet

Each sachet contains:-

Form-5 18-2-2014 Dy # 619 R&I

Deferred in 244th RB meeting for clarification of

All shortcomings rectified.

Approved


euticals (Pvt.) Ltd, 13-km, Bosan Road, Luftabad, Multan

granules of Montilukast (as sodium) 4mg

Leukotriene receptor antagonistManufacture Specification

Rs.20,000/-

Rs.225.00/14‟s sachet

MHRA approved

manufacturing process for granules.

Deferred cases of pendency list

414. M/s Himont Pharmaceuticals (Pvt.) Ltd, 17-km, Ferozpur Road, Lahore

Priority # 2655

Deproset Capsule 20mg

Each capsule contains:-Duloxetine HCl enteric coated pellets eq. to Duloxetine 20 mg SSRIManufactures specification

Source of pellets:-

Form 5 with fee Rs. 20,000/- vide Dy. # 592 dated 06-09-2013


Cymbalta-Eli Lilly-FDA

Llario-Wilshire

The Board deferred the case in 258th RB meeting, for provision source of pellets along with relevant documents

Firm has submitted source of pellets as under:-Source of Duloxetine HCl ECP 19.0%M/s Vision Pharmaceuticals, Plot # 22, Industrial Trinagle, Kahuta Road, Islamabad.

Approved


Priority # 2654



Source of pellets:-




Llario-Wilshire

The Board deferred the case for provision source of pellets along with relevant documents.


Approved


Priority # 2654



Source of pellets:-




Llario-Wilshire

The Board deferred the case for provision source of pellets along with relevant documents.


Approved


417. M/s Getz Pharma, 29-30/27, Korangi Industrial Area, Karachi

2053

Lyta 40mg Capsule

Each capsule contains:Enteric coated pellets of Duloxetine HCl eq to Duloxetine………. 40mg

(Selective serotonin Norepinephrine reuptake inhibitor)(Mfg. Specification)Duloxetine is indicated for women for the treatment of moderate to severe stress urinary incontinence.

Form-5-DDy. No: 114 dated. 19.02.2011Rs.15,000/-19.09.2013Rs.5,000/-Rs. 645/14’s,925/20’s

Duloxetine 20mg & 40mg gastric resistant capsules (Consilient Health Ltd) MHRA

Dulan –HiltonReg# 067169

Deferred for Balance fee of form 5 D, Legalized documents of the source and Fee for source.Stability studies as per 251st meeting of RB.

Firm has rectified all shortcomings. Product is

already registered in Pakistan.

Firm submitted fresh Form 5.

Firm has submitted legalized documents of GMP and free sale certificate of Source of Duloxetine Delayed released pellets 17.65% w/w:-

M/s Alphamed Formulations Pvt Ltd, Sy. No. 225, Sampanhole Village, Shameerpet Mandal, Ranga Reddy District 500 078, Telangana state, India

Approved

418. M/s Pharmacare Labs (Pvt) Ltd, 129/1, Industrial Estate, Kotlakhpat, Lahore.1462

Lexxel Tablet

Each film coated tablet contains:- Escitalopram Oxalate USP eq.to Escitalopram 20mg

Anti-depressantUSP Specification

Form 5Dy No.1166 Rs.8000 dated 28-12-2011 & Rs. 12,000 dated 31-07-2013. As per SRO

MHRA Cipralex 20mg f/c tabletCipralex 20mg by M/s Lundbeck

Deferred 254th RB for Raw material and

finished product specifications need to be submitted.

Outline of manufacturing method needs to be provided.

Description of the dosage form is not provided.

Fresh inspection require to be submitted.

All shortcomings rectified.

Approved

419. M/s Reevo .Form5 Deferred 244th for Deferred for


Allmed Pvt.Ltd.(Formerly,EverGreenPharmaceuticals,Pvt. Ltd.Plot.No.590,Sundar IndustrialEstate Lahore.

InjectionEach ml contains:Levocarnitine…………..200 mg4.Anti infectivesystematic

2.Routine3.Rs.5mlx10‟s/ Asper SRO4.23-08-2010Rs.8000/-11-10-2012Rs.12,000/-

FDA: CarnitorKefei Injection by M/s RG Pharma

confirmation ofpharmacologicalgroup as applied byfirm.

correct pharmacological group and submission of stability data as per 251st RB meeting

420. -do- MetorilTabletEach tablet contains:NitrogenContents…36mgCalcium .0.5gmAminoacids

1.Form52.Routine3.100‟s/As per SRO4.06-08-2010Rs.8000/-11-10-2012Rs.12,000/

Ketosteril by M/s Fresenius Kabi Pharma Germany.

Ketosteril by M/s Medipak Pharma

Deferred 244th forconfirmation ofinternationalavailability and faciltyfor processing ofnitrogen preparations

Registration Board deferred the case for provision of complete master formulation and confirmation of approval status in Pakistan

DDC PEC-I Dr. Hafsa Karam Ellahi

Sr. No Name and address of manufacturer / Applicant


Type of Form

Initial date, diary

Fee including differential feeDemanded Price / Pack size


Remarks by Evaluator /Decision

Decision


421. M/s Irza Pharma (Pvt) Ltd. 10.2 K.M Lahore – Sheikhupura Road, P.O.Kot Abdul Malik, Distt: Sheikhupura.1378

Dephan SyrupEach 5ml contains:Dextromethorphan HBr ….13.5mg(Antitussive)Protocol Applied: USP

Form 5Dairy No. 705dated 04.10.11Rs.8,000/-dated 29.07.2013Rs.12,000/-As per SRO120ml

International availability not confirmedDe xtromethrphanHBr 13.5 mg of Neutropharma Last GMP inspection was conducted on 28-04-2014

Deferred in 255th

meeting of DRB for latest

cGMP inspection report.

availability in SRA is not confirmed.

Now the firm has submitted latest cGMP report dated 21-03-2016.



Dephan SyrupEach 5ml contains:Dextromethorphan HBr …..10mgChlorpheniramine Maleate……2mg(Antitussive / Antihistamine)Protocol Applied: USP

Form 5Dairy No. 706 dated 04.10.11Rs:8,000/-dated 29.07.2013Rs.12,000/-As per SRO120ml

International availability not confirmed

BUCKLEYS JACK & JILL (Pacific Phararmaceutical

Last GMP inspection was conducted on 28-04-2014

Deferred in 255th



availability in SRA is not confirmed.




R-Din InjectionEach 2ml contains:Ranitidine HCl equivalent to Ranitidine………50mg(H 2 Blocker)

Form 5Dairy No. 4831dated 28.04.11Rs.8,000/-dated 29.07.2013Rs.12,000/-As per SRO5’s

International availability FDA approved Zantac Eq to 25MG Ranitidine Base/Ml Concordia Pharms Inc

Deferred in 255th




Approved



Irzaline InjectionEach 1ml contains:Lincomycin Hydrochloride equivalent to Lincomycin………300mg(Lincosamide)


International availability FDA: Lincocin Lincomycin HCl Eq. 300mg base per ml(Pharmacia and Upjohn) Lincocin (pfizer laboratories ltd. (Lincomycin HCl), equivalent to Lincomycin……..300mgLast GMP inspection was conducted on 28-04-2014

Deferred in 255th




Approved


Irzaline InjectionEach 2ml contains:Lincomycin Hydrochloride equivalent to Lincomycin…. 600mg(Lincosamide)


International availability FDA: Lincocin Lincomycin HCl Eq. 300mg base per ml(Pharmacia and Upjohn) Lincocin (pfizer laboratories ltd. (Lincomycin HCl), equivalent to Lincomycin………600mg/2mlLast GMP inspection was conducted on 28-04-2014

Deferred in 255th




Approved


Asmolin InjectionEach ml contains:Aminophylline……..25mg(Antiasthmatic)

Form 5Dairy No. 618 dated 28.05.11Rs.8,000/-dated 29.07.2013Rs.12,000/-As per SRO5’s

Aminophylline 25mg/mlMercury pharma UKAminophylline Hydrate 25mg/ml Sol for Inj ofUSFDAAminophylline 25mg/mlGD SEARLE LLC(Discontinued) Aminophylline 25mg/ml of LCPWLast GMP inspection was conducted on 28-04-2014

Deferred in 255th



Change of name


Approved with change of brand name



Jantolin InjectionEach 1ml contains:Salbutamol Sulphate equivalent to Salbutamol…. 0.5mg(Selective Beta 2 Agonist)


International availabilityVentolin Injection (0.5mg) in 1mlGlaxo Wellcome UK LtdMe too : ventralAkson

Last GMP inspection was conducted on 28-04-2014

Deferred in 255th



Change of mame




I-Menate InjectionEach 1ml contains:Dimenhydrinate…….50mg(Antihistamine)


DIMENHYDRINATE 50MG/ML INJECTION OF FRESENIUS KABI USFDA

Gravinate injection Searl pharmaLast GMP inspection was conducted on 28-04-2014

Deferred in 255th




Approved


I-Cobal InjectionEach 1ml contains:Mecobalamin…….500mcg(Coenzyme type vitamin B12)


Methycobal amine of Eisai Co. Ltd. JapanMabil Injection (Sami Pharma, Karachi).Last GMP inspection was conducted on 28-04-2014

Deferred in 255th



Change of name



Import Case of M/s Atco Pharma was deferred in 255th meeting of RB.


Sr. No Name and address of manufacturer / Applicant


Type of Form

Initial date, diary




Decision

430. Atco pharma International (PVT.)LTD B-18, S.I.T.E, Karachi-75700Name and address of Manufacturer;Laboratorio Pablo Cassar’a S.R.LCarhue 1096. (C.P.1408)City: Buenos AiresCountry: Argentina

52

Micopirox, Nail LacquerCyclopirox 8mg/100gBP Specification

Form 5-ARs. 15000 dt 19-04-2011Rs. 85000 dt 04-06-2013 Rs. 600

Penlac,8%Topical solution of (Valeant Bermuda)USFDA

Deferred in 255th meeting for the following reasons;CPP issued on

Feb 2011 and is valid for 12 months.

Last GMP certificate was issued on Nov 2010 and is in local language. Latest legalized Certificate with English translation required.

Sole agreement of Laboratory Pablo Cassara with Atco is valid till December 2015. Extension in the agreement



is required.


Routine Cases.

S. No Name and address of manufacturer / Applicant


Type of Form

Initial date, diary




Decision

431.M/s. Friends Pharma (Pvt) Limited, 31Km Ferozpure Road, Lahore 1092

Bactriol infusion Each 250ml contains:Moxifloxacin……400mg

(Anti-biotic)

Form 5Dy.No.56128-05-2011Rs:8,000/- 14.05.2013Rs.. 12000/-As per SRO

Avelox I.V by M/s. Bayer Inc. US FDAAvilox Infusion by M/s. Baeyer (Pvt) Limited, Karachi

Approved

432. M/s. Friends Pharma (Pvt) Limited, 31Km Ferozpure Road, Lahore1091

Cipfen infusion Each 100ml contains:Ciprofloxacin …200mg

(Anti-biotic)

Form 5Dy.No.52203-05-2011Rs:8,000/- 14.05.2013Rs.. 12000/-As per SRO

Ciprofloxacin 2mg / ml byPharmathenMHRA

cipesta Infusion by M/s. Getz Pharma

Approved

433. M/s Remington Pharma Lahore846

Zylofixim Capsule Oral Capsules Each Capsule contains:Cefixime Trihydrate U.S.P equivalent to Cefixime…..200mg(Antibiotic).Manufacturer’s Specification

Form 5Dy.No.389828-03-2011Rs:8,000/- Dy. No. 927630.07.2013Rs.. 12000/-Leader Price

Applied formulation is not available in reference SRA’s.Cefim by M/s Getz Pakistan

Applied formulation is not available in reference SRA’s.The firm also fails to provide the same.




Nilol 10mgTabletEach tablet contains:Nebivolol Hcl eq to Nebivolol……10mgBeta BlockerManufacturer’s Specification

Form 5Dy.No.13623-2-2016Rs:20,000/- As per PRCAs per PRC

Bystolic Tablet of Forest Labs US FDA

ByscardTabletSearle Pakistan

Approved


Malfan 80/480 DispersibleOral dispersible TabletEach dispersible tablet contains:Artemether……80mgLumefantrine……480mg(Anti Malarial)Manufacturer’s Specification

Form 5Dy.No.150004-8-2011Rs:8,000/- Dy. No. 929630.07.2013Rs12000/-Leader Price

Applied formulation is not available in reference SRA’s.Alar once Dispersible by M/s Searle Pharma


Deferred for confirmation of approval status by reference regulatory authorities / WHO


Malfan 40/240 DispersibleOral TabletEach tablet contains:Artemether……40mgLumefantrine……240mg

(Anti Malarial)Manufacturer’s Specification


Applied formulation is not available in reference SRA’s.Alar once Dispersible by M/s Searle Pharma


Deferred for confirmation of approval status by reference regulatory authorities /WHO


Nebra-D Ophthalmic suspension Each ml contains:Tobramycin U.S.P……3.0 mgDexamethasone U.S.P……1.0mgBoric Acid B.P….5mgManufacturer’s Specification(antibacterial, corticosteroid)Manufacturer’s Specification


Applied formulation is not available in reference SRA’s.Me too status is not confirmed


Rejectedbeing irrational formulation and not approved by ant reference regulatory authoritity



Remflox 750Oral TabletEach film coated tablet contains:Levofloxacin Hemihydrates eq. to Levofloxacin U.S.P (Antibiotic, quinolones)Manufacturer’s Specification


Levaquin Tablet of Janssen Pharms US FDALeflox by M/s Getz Pharma

Shelf life provided by the firm is three years whereas 2 years are allowed by the Board.

Approved


Zincure Oral SyrupEach 5ml contains:Zinc Sulphate Monohydrate U.S.P equivalent to Elemetal Zinc………20mg

(Zinc Supplement)Manufacturer’s Specification

Form 5Dy.No. 585329-06-2012Rs:8,000/- 30.07.2013Rs12000/-Leader Price

Applied formulation is not available in reference SRA’s.

Deferred for opinion/comments of WHO as per decision of the board in 250th meeting. Dosage recommendation (UNICEF/ WHO): Tablets may contain either 10 or 20 mg of zinc and the concentration of zinc in oral solutions may be 10mg/5mL. Decisions about the best strength to be used should depend on better adherence to treatment by patient, taking into consideration other issues as well, such as price, medicine delivery, and duration of treatment (10- or 14-day treatment). Preferably, in any given country, only one strength of tablets or oral solution should be available to avoid dosing errors. If 10-mg zinc tablets are chosen, it will mean that older

Deferred for opinion/comments of WHO as per decision of the board in 250th meeting.


children will have to take two tablets each day; if 20mg zinc tablets are chosen, it will mean that for younger infants only half a tablet will be given each day and therefore tablets will have to be scored to facilitate this. With oral solutions, because it is difficult to accurately measure half a teaspoon of solution, it is recommended that oral solution of zinc contain 10mg of elemental zinc per 5 mL, that is to say per one teaspoon. It means that infants below 6 months of age will receive one teaspoon, while older children will need 2 teaspoons of oral solution per day. (Ref: UNICEF/ WHO)


Remisole-P Syrup Each 5ml contains:Ammonium Chloride B.P….100mgSodium Citrate B.P….60mgChlorpheniramine Maleate B.P……2mgPhenylephrine HCl B.P…..5mgMenthol B.P…..1.0mg(Expectorant)Manufacturer’s

Form 5DDy.No. 585229-06-2012Rs:15,000/- 30.07.2013Rs35000/-Rs. 45/60mlRs. 65/120mlRs. 200/450ml

Applied formulation is not available in reference SRA’s.


Deferred for confirmation of approval status by reference regulatory authorities and Pakistan


Specification


MoxidexEach ml contains:Moxifloxacin Hydrochloride B.p Equivalent to Moxifloxacin…..5mgDexamethasone Sodium Phosphate U.S.P eq. to Dexamethasone Phosphate…..1mg(Antibiotic & Corticosteroid)Manufacturer’s Specification

Form 5Dy.No. 146523-04-2012Rs:8,000/- 30.07.2013Rs 12,000/-Leader Price

Applied formulation is not available in reference SRA’s.Oxcin-D by M/s Atco Pharma




Moxear-Pain otic dropsEach ml contains:Moxifloxacin HCL B.P Equivalent to Moxifloxacin…..5mgLignocaine HCL B.P equivalent to Lignocaine base ……50mg(Antibiotic and local Anaesthetic) Manufacturer’s Specification

Form 5Dy.No. 146523-04-2012Rs:8,000/- 30.07.2013Rs 12,000/-Leader Price

Applied formulation is not available in reference SRA’s.Me too status is not confirmed


Deferred for confirmation of approval status by reference regulatory authorities and pakistan


Valpin-H 5/160/25Oral Tablet Each film coated tablet contains:Amlodipine (as Besylate) B.P…..5mgValsartan U.S.P…..160mgHydrochlorothazide U.S.P…..25mg(Calcium Channel Blocker, Angiotensin-II Receptor Antagonist & Thiazide Diuretic ) Manufacturer’s Specification

Duplicate Dossier Form 502-02-2011Rs:8,000/- 30.07.2013Rs 12,000/-Leader Price

Exforge HCTNovartis US FDAValam-H 5/160/25by M/s. CCL Pharma

Approved



Valpin 10/80Oral Tablet Each film coated tablet contains:Amlodipine (as Besylate) B.P…..10mgValsartan U.S.P…..80mg (Calcium Channel Blocker, Angiotensin-UII Receptor Antagonist & Thiazide Diuretic ) Manufacturer’s Specification


Applied formulation is not available in reference SRA’s.Valam10/80 by M/s. CCL Pharma




Valpin-H 10/160/25Oral Tablet Each film coated tablet contains:Amlodipine (as Besylate) B.P…..10mgValsartan U.S.P…..160mgHydrochlorothazide U.S.P…..25mg(Calcium Channel Blocker, Angiotensin-UII Receptor Antagonist & Thiazide Diuretic ) Manufacturer’s Specification


Exforge HCTNovartis US FDA

Valam-H 10/160/25by M/s. CCL Pharma

Approved


Valpin-H 10/320/25Oral Tablet Each film coated tablet contains:Amlodipine (as Besylate) B.P…..10mgValsartan U.S.P…..320mgHydrochlorothazide U.S.P…..25mg(Calcium Channel Blocker, Angiotensin-UII Receptor Antagonist & Thiazide Diuretic ) Manufacturer’s Specification


Exforge HCTNovartis US FDA

Valam-H 10/320/25by M/s. CCL Pharma

Approved


Following products of M/s. Friends Pharma (Pvt.) ltd were deferred in 257th meeting of Drug registration board for approval status of same formulation in reference regulatory authorities and for finished product specification. Now the firm has submitted the evidence of same formulation in reference regulatory authorities and for finished product specification. Submitted for consideration of Board.





Remarks by Evaluator

Decision

447. M/s. Friends Pharma (Pvt) Limited, 31Km Ferozpure Road, Lahore 1095

Ferifend Injection Each ml contains: Piroxicam……….20mg

(Analgesic)

Form-5 Dy. No: 547 dated. 28-05-2011 Rs.8000/- Rs.12,000/- As per SRO

International availability is not confirmedpcam By M/sMerck Laboratories.

International availability is not confirmed


448. M/s. Friends Pharma (Pvt) Limited, 31Km Ferozpure Road, Lahore 1089

Nootrofil Injection Injection Each ml contains: Piracetam……..200mg

(Nootropic Drug)

Form-5 Dy. No: 553 dated. 28-05-2011 Rs.8000/- Rs.12,000/- As per SRO/200mg/ml

Availability in SRA is not confirmed

Nootropil injection by Glaxosmithkline, Pakistan 1G/ 5ml

Piracetam is a cyclic derivative of GABA. In the United States, it is not approved by the US Food and Drug Administration for any medical use and it is not permitted to be sold as a dietary supplement. In the UK, piracetam is prescribed mainly for myoclonus, but is used off-label for other conditions. Evidence to support its use for many conditions is unclear.



DDC PEC-II Muhammad Amin.

Sofosbuvir Cases.





Remarks by Evaluator

Decision

449. M/s NovaMed Pharmaceuticals (Pvt) Ltd, Lahore.

Ledinil TabletTablet Each tablet contains:-Sofosbuvir……400mgLedipasvir……90mg(Manufacturer’s Specs)

Form 5-DDairy No. 1928dated 20-04-2014Rs.50,000/- 14’s, 28’s Rs.630,000/-Rs.11,97,000/-

Harvoni, FDA.

Harvoni, Ferozsons, Pakistan.

Stability studies not submitted.

Last Inspection report required. \

Undertaking as per new format.

Deferred for rectification of mentioned deficiencies and submission of stability data

450. M/s Barrett Hodgson Pakistan (Pvt) Ltd. Karachi.

Hepgard Plus Tablet Each film coated tablet contains:-Sofosbuvir……400mgLedipasvir……90mg(Direct-acting antiviral agent against the hepatitis C virus)(Mnf Specs)

Form 5-DDairy No. 5335dated 21-08-2015Rs.50,000/- 7’s,10’s,14’s,20’s, 28’s,30’s Rs.24,500/-Rs.35,000/-Rs.49,000/-Rs.70,000/-Rs.1,05,000/-

Harvoni, FDA.



Last Inspection report required.

Undertaking as per new format


451. M/s Barrett Hodgson Pakistan (Pvt) Ltd. Karachi.

Hepgard Tablet Each film coated tablet contains:-Sofosbuvir……400mg (Direct-acting antiviral agent against the hepatitis C virus)(Mfg Specs)

Form 5Dairy No. 5336dated 24-08-2015Rs.20,000/- 7’s,10’s,14’s,20’s, 28’s,30’s Rs.17,500/-Rs.25,000/-

Sovaldi, USA.

Sovaldi, Ferozsons, Pakistan





Rs.35,000/-Rs.50,000/-Rs.70,000/-Rs.75,000/-


452. M/s Indus Pharma (Pvt.) Ltd.,

Indovir 400mg Tablet Each film coated tablet contains:-Sofosbuvir……400mg(Anti-Viral)

Form 5-DDairy No. 264dated 17-09-2014Rs.20,000/- As per SRO]As per SRO

Sovaldi, USA.




Undertaking as per new format not submitted.


453. M/s Nawan Laboratories Pvt Ltd. Karachi.

Virosof Tablet Each film coated tablet contains:-Sofosbuvir……400mg(Antihepatitis ATC Code: JO5AB)(Manufacturer’s Specs)

Form 5Dairy No. 402dated 22-03-2016Rs.20,000/- As per SROAs per SRO

Sovaldi, USA.






454. M/s Helix Pharma (Pvt) Ltd Karachi.

Sofoled 90mg/400mg Tablet Each film coated tablet contains:-Ledipasvir……90mgSofosbuvir……400mg(Direct Acting Antiviral)

Form 5-DDairy No. 512dated 11-04-2016Rs.50,000/- As per SROAs per SRO

Harvoni, FDA.





455. M/s Paramount Pharmaceutical Islamabad.

Savior Tablet Each tablet contains:-Sofosbuvir……400mg(Anti-infective, Antiviral)

Form 5Dairy No. 1201dated 09-10-2015Rs.20,000/- As per SRO

Sovaldi, USA.



Last Inspection report



required. Undertakin

g as per new format

456. M/s Rotex Pharma Islamabad.

Sonata Tablet Each film coated tablet contains:-Ledipasvir…….90mgSofosbuvir……400mg(Nucleotide Analog NSB Polymerase Inhibitor & Nucleotide NS5B Inhibitor Anti viral)

Form 5Dairy No. 78dated 11-01-2016Rs.50,000/- 28’sAs per SRO

Harvoni, FDA.



Undertaking as per new format.

Inspection report states that firm has limited capacity of production.


457. M/s Pharmix Laboratories Pvt Ltd, Lahore

Alvir Tablet Each film coated tablet contains:-Ledipasvir…….90mgSofosbuvir……400mg(Antiviral Agent)

Form 5-DDairy No.1452dated 13-11-2015Rs.50,000/- 28’sRs.100,000/-

Harvoni, FDA.






458. M/s Nexus Pharma Karachi.

Sofonex Tablet Each film coated tablet contains:-Sofosbuvir……400mg(Hepatitis C virus (HCV) Nucleotide analog

Form 5-DDairy No.2299dated 25-11-2015Rs.50,000/- As per SRO

Sovaldi, USA.







459. M/s Bosch Pharmaceutical Karachi.

Lesovir Tablet Each film coated tablet contains:-Ledipasvir……90mgSofosbuvir……400mg(Hepatitis C virus (HCV) nucleotide analog NSB polymerase inhibitor)

Form 5Dairy No.87dated 20-01-2016Rs.20,000/- 28’sAs per SRO

Sovaldi, USA.





460. M/s Siam Pharmaceuticals Islamabad.

Sifos Plus Tablet Each film coated tablet contains:-Ledipasvir……90mgSofosbuvir……400mg(Antiviral)


Sovaldi, USA.



Last Inspection report required..



461. M/s Crystolite Pharmaceuticals, Islamabad.

HepledTablet Each film coated tablet contains:-Ledipasvir……90mgSofosbuvir……400mg(Antiviral against Hepaptis C)(Manufacturer’s Specs)


Harvoni, FDA.




462. M/s Medisave Pharmaceuticals Lahore.

Sobovir Tablet Each film coated tablet contains:-Sofosbuvir……400mg(Antivirals for systemic use)

Form 5Dairy No.1092dated 12-10-2015Rs.20,000/- As per SRO

Sovaldi, USA.







463. M/s Global Pharmaceutical Pvt. Ltd Islamabad.

Cure-C Plus Tablet Each film coated tablet contains:-Sofosbuvir……400mgLedipasvir…..90mg(Anti-viral agent)Manufacturer’s Specs


Harvoni, FDA.





464. M/s Jenner Pharmaceuticals Pvt. Ltd.

Sobovir Tablet Each film coated tablet contains:-Sofosbuvir……400mg(Direct-acting antiviral)Manufacturer’s Specs

Form 5Dairy No.1205dated 20-10-2015Rs.20,000/-28’s As per SRO

Sovaldi, USA.




465. M/s Martin Dow Karachi.

Osvir Plus Film coated Tablet Each film coated tablet contains:-Sofosbuvir……400mgLedipasvir…….90mg(Antiviral)Manufacturer’s Specs

Form 5-DDairy No.795dated 04-11-2015Rs.50,000/-7’s,14’s,28’s Rs.21,000/-Rs.42,000/-Rs.84,000/-

Harvoni, FDA.





466. M/s Wilshire Laboratories (Pvt) Ltd. Lahore.

Ziqar Plus Tablet Each film coated tablet contains:-Sofosbuvir……400mgLedipasvir…….90mg(Antiviral)

Form 5-DDairy No.795dated 04-11-2015Rs.50,000/-1’s,5’s,10’s,30’s, 50’s As per SRO

Harvoni, FDA.






467. M/s Saffron Pharmaceutical Faisalabad.

Viraldi Tablet Each tablet contains:-Sofosbuvir……400mgLedipasvir…….90mg(HCV NS5A Inhibitor and Nucleotide analog inhibitor of Hcv NS5B Polymerase.)

Form 5-DDairy No.185dated 07-12-2015Rs.50,000/-30’sRs.60,000/-

Harvoni, FDA.





468. M/s Seatle Pvt Limited, Lahore.

Isuvir PlusTablet Each film coated tablet contains:-Sofosbuvir……400mgLedipasvir…….90mg(Antiviral.)

Form 5-DDairy No.1361dated 04-11-2015Rs.50,000/-7’s,14’s,28’s Rs.21,000/-Rs.42,000/-Rs.84,000/-

Harvoni, FDA.





469. M/s OBS Pakistan, Karachi.

Viratron-PlusFilm coated Tablet Each film coated tablet contains:-Sofosbuvir……400mgLedipasvir…….90mg(Antiviral.)Manufacturer’s Specs

Form 5-DDairy No.214dated 03-06-2015Rs.50,000/-28’s Rs.364,000/-

Harvoni, FDA.






470. M/s Hilton Pharma, Karachi

SofoledFilm coated Tablet Each film coated tablet contains:-Sofosbuvir……400mgLedipasvir…….90mg(Antiviral.)Manufacturer’s Specs

Form 5-DDairy No.273dated 06-03-2015As per DPC Rs.364,000/-

Harvoni, FDA.





471. M/s Tabros Pharma, Karachi

Concerta 400/90 mg TabletsEach Film coated tablets contain:Sofosbuvir….400 mgLedipasvir…….90 mg

Form 5-DDairy No.273dated 06-03-2015As per DPC Rs.3392.85 per tablet.Pack 2 × 14: Rs 95000/-

Harvoni, FDA.







472. M/s Sami, Karachi

Daclavir 30 mg tabletsEach film coated tablet contains:Daclatasvir (as dihydrochloride) 30 mgMfg Specs

Form 5-DDy no: 1241 dated: 14.6.2016Rs: 50,000Price: 6500/ 28 Tablets

Deklinza of M/s BMS, UK.

New Molecule

Stability data of 06 months accelerated and real time is required


473. M/s Sami, Karachi

Daclavir 60 mg tabletsEach film coated tablet contains:Daclatasvir (as dihydrochloride) 60 mgMfg Specs

Form 5-DDy no: 1240 dated: 14.6.2016Rs: 50,000Price: 13000/ 28 Tablets


New Molecule

-do- Deferred for rectification of mentioned deficiencies and submission of stability data


Clavir tablets 30 mgEach film coated Tablet :Daclatasvir …………30mg (equivalent to 33mg daclatasvir dihydrochloride)

Form 5-DDy. No. 403dated: 14.09.2015Rs: 50,000As Per DPC


New Molecule

Stability data of 06 months accelerated and real time is required



Clavir tablets 60 mgEach film coated Tablet :Daclatasvir …………60mg(equivalent to 66mg daclatasvir dihydrochloride)

Form 5-DDy. No 402 dated: 14.09.2015Rs: 50,000As Per DPC


New Molecule

-do- Deferred for rectification of mentioned deficiencies and submission of stability data


Deferred Cases:

Following cases of M/s Selmore Pharmaceutical Lahore were deferred in M-258th due to me too status now the firm has submitted the deficiencies.





Decision

476. M/s. Selmore Pharmaceuticals (Pvt) Limited, 36 Km, Multan Road, Lahore.

Novacin intra-Mammary Suspension Liquid InjectableEach 5ml contains:-Penicillin G Sodium…………..200,000IUNovobiocin Sodium eq. to Novobiocin ………………….400mg(2 years)

Form-5Dy. No.138Dated.28-01-2016Rs.20,000/- Decontrolled10ml,10ml x 12’s 10mlx24’s

Me-too not available

Rejected on the grounds that me-too of the drug is not available

477. M/s. Selmore Pharmaceuticals (Pvt) Limited, 36 Km, Multan Road, Lahore.

Speclimox Oral Dry PowderOral Dry PowderEach Kg powder contains:-Amoxicillin Trihydrate (BP) eq. to Amoxicillin…………….......200mgLincomycin HCI (BP) eq. to Lincomycin…..88mg Spectinomycin Sulphate (BP VET). eq. to Spectinomycin……........88mg(Board Spectrum Antibiotics (Penicillin/ Aminoglycosides)02 years

Form-5Dy. No.133Dated.28-01-2016Rs.20,000/- Decontrolled100gm,250gm500gm,1Kg

Me-too not available

Rejected on the grounds that me-too of the drug is not available


Grant of Registration to New Drug Manufacturing Licenses

DDC-PEC-I Dr.Hafsa Karam Ellahi




International status in reference drug agencies / authorities Me-too status GMP status as depicted in latest inspection report (with date) by the Evaluator

Remarks Decision

Tablet (General)478. Scilife Pharma

(Private) LimitedPlot # FD-57/58-A2, Korangi Creek Industrial park (KCIP) Karachi

Tablet (General) approved in 247st meeting of Central Licensing Board held on 29-04-2016.

Leflo Tablet 250 mg Each film coated tablet contains: Levofloxacin 250 mg (as hemihydrates) (Scilife Spec) Quinolone Antibiotics

Form 5Rs. 20,000/-Dy. No.1156 08-06-201610’s,30’sAs Per SRO

FDA approved Tablet Levaquin 250 mg manufactured by Janssen Pharms

Tablet Dynaquin 250 mg by Barrett Hodgson

Approved

479. -do- Leflo Tablet 500 mg Each film coated tablet contains: Levofloxacin 500 mg (as hemihydrates) (Scilife Spec) Quinolone Antibiotics



Tablet Dynaquin 500 mg by Barrett Hodgson

Approved

480. -do- Leflo Tablet 750 mg Each film coated tablet contains: Levofloxacin 750 mg (as hemihydrates)

Form 5Rs. 20,000/-Dy. No. 115408-06-201610’s,30’s


Approved


(Scilife Spec) Quinolone Antibiotics

As Per SROLeflox by M/s Getz Pharma

481. -do- Amstan Tablet 5/80 mg Each film coated tablet contains: Amlodipine: 5 mg (as Amlodipine Besylate)Valsartan: 80 mg(Scilife Spec) Anti-Hypertensive

Form 5Dy. No. 1206Dated.08-06-2016Rs. 20,000/- Pack of 14’s,28’s /as per SRO

FDA approved Tablet Exforge 5/80 mg manufactured by Novartis

Tablet Avsar 5/80 mg manufactured by Pharmevo

Approved


Form 5Rs. 20,000/- Dy. No.1207Dated.08-06-2016 14’s,28’s As Per SRO



Approved


Form 5Rs. 20,000/- Dy. No.1208Dated.08-06-2016 14’s,28’s As Per SRO



Approved

484. -do- Co-Amstan Tablet 5/160/12.5 mg Each film coated tablet contains: Amlodipine: 5 mg (as Amlodipine Besylate)Valsartan: 160 mgHydrochlorothiazide USP: 12.5 mg(Scilife Spec) Anti-Hypertensive

Form 5Rs. 20,000/-Dy. No. 120908-06-201614’s,28’sAs Per SRO

FDA approved Tablet Exforge HCT 5/160/12.5 mg manufactured by Novartis

Tri-Valsan by M/s Hilton Pharma

Approved

485. -do- Co-Amstan Tablet 10/160/12.5 mg Each film coated tablet contains: Amlodipine: 10 mg

Form 5Rs. 20,000/-Dy. No.117308-06-201614’s,28’s

FDA approved Tablet Exforge HCT 10/160/12.5 mg manufactured by

Approved


(as Amlodipine Besylate)Valsartan: 160 mgHydrochlorothiazide USP: 12.5 mg(Scilife Spec) Anti-Hypertensive

As Per SRO Novartis

Tri-valsan by Hilton Pharma

486. -do- Co-Amstan Tablet 5/160/25 mg Each film coated tablet contains: Amlodipine: 5 mg (as Amlodipine Besylate)Valsartan: 160 mgHydrochlorothiazide USP: 25 mg(Scilife Spec) Anti-Hypertensive

Form 5Rs. 20,000/-Dy. No. 117208-06-201614’s,28’sAs Per SRO

FDA approved Tablet Exforge HCT 5/160/25 mg manufactured by Novartis


Approved


Form 5Rs. 20,000/-Dy. No. 116908-06-201614’s,28’s



Approved


Form 5Rs. 20,000/- Dy. No.115708-06-2016)14’s,28’sAs Per SRO



Approved

489. -do- Cowaldi Tablet 400 mg Each film coated tablet contains: Sofosbuvir 400 mg (Scilife Spec) Anti-Hepatitis C

Form 5Rs. 20,000/-Dy. No. 118608-06-201630’s As Per SRO

FDA approved Tablet Sovaldi 400 mg manufactured by Gilead science

Tablet Sofos 400 mg by Genix Pharma

Stability data is required.

Deferred for submission of stability data as per guidelines approved by registration Board in


251st

meeting

490. -do- Arixa Tablet 10 mg Each film coated tablet contains: Rivaroxaban 10 mg(Scilife Spec) Anti-Coagulant


FDA approved Tablet Xarelto 10 mg manufactured by Janssen Pharms

Tablet Xarelto 10 mg manufactured by Bayer

Approved





Approved


Form 5Rs. 20,000/-Dy. No.1189 08-06-201614’s,28’s



Approved

493. -do- Wilda-M Tablet 50/500 mg Each film coated tablet contains: Vildagliptin 50 mgMetformin HCl 500 mg(Scilife Spec) Anti-Diabetic

Form 5Rs. 20,000/-Dy. No.119208-06-201614’s,28’s As Per SRO

TGA & EMA approved Tablet Eucreas 50/500 mg manufactured by Novartis

Tablet Galvus Met 50/500 mg manufactured by Novartis

Approved

494. -do- Wilda-M Tablet 50/850 mg Each film coated tablet contains: Vildagliptin 50 mg

Form 5Rs. 20,000/-Dy. No.1188 08-06-2016

14’s,28’s


Approved


Metformin HCl 850 mg(Scilife Spec) Anti-Diabetic

As Per SRO TabletGalvus Met 50/850 mg manufactured by Novartis

495. -do- Wilda-M Tablet 50/1000 mg Each film coated tablet contains: Vildagliptin 50 mgMetformin HCl 1000 mg(Scilife Spec) Anti-Diabetic

Form 5Rs. 20,000/-Dy. No.1187 03-06-2016Pack of 14’s/as per DPC28’s / as per DPC


TabletGalvus Met 50/1000 mg manufactured by Novartis

Approved

496. -do- Dolobid-P Tablet 325/37.5 mg Each film coated tablet contains: Paracetamol325 mgTramadol HCL 37.5 mg (Scilife Spec) Analgesic

Form 5Rs. 20,000/-Dy. No.1190/- 08-06-201610’s,30’sAs Per SRO

FDA approved Tablet Ultracet 325/37.5 mg manufactured by Janssen Pharm

Tablet Tramal Plus 325/37.5 mg manufactured by Searle Pharma


497. -do- Omitax Tablet 10/10 mg Each enteric coated tablet contains Doxylamine Succinate 10 mgPyridoxine Hydrochloride 10 mg (Scilife Spec) Anti-emetic

Form 5Rs. 20,000/-Dy. No. 118508-06-201610’s,30’s

FDA approved Tablet Diclegis 10/10 mg manufactured by Duche Snay

Tablet Envepe 10/10 mg manufactured by RG Pharma

Approved

498. -do- Romilast Tablet 500 mcg Each tablet contains: Roflumilast 500 mcg(Scilife Spec) Phosphodiesterase Inhibitor

Form 5-DRs. 50,000/-Dy. No. 08-06-201610’s,20’s,30’sAs Per SRO

FDA approved Tablet Daliresp 500 mcg manufactured by Astrazeneca Pharms

Stability data is required.

Deferred for submission of stability data as per guidelines approved by registratio


n Board in 251st

meeting

499. -do- Scimox Tablet 400 mg Each Film coated tablet contains:Moxifloxacin…400 mg (as Hydrochloride) (Scilife Spec) Quinolones Antibiotic

Form 5Rs. 20,000/-Dy. No. 1191 08-06-20165’s/ As Per SRO

FDA approved Tablet Avelox 400 mg manufactured by Bayer Health care

Tablet Moxiget 400 mg manufactured by Getz Pharma

Approved

Capsule (General)500. Scilife Pharma

(Private) LimitedPlot # FD-57/58-A2, Korangi Creek Industrial park (KCIP) Karachi

Capsule (General) approved in 247st meeting of Central Licensing Board held on 29-04-2016.

Dolobid Capsule 50mg

Each capsule containsTramadol HCl 50mg

Analgesic (Scilife Spec)

Form 5Rs. 20,000/- Dy. No.118308-06-201610’s,30’sAs Per SRO

TGA Approved Zydol by M/s Arrow Pharma

Tamadol 50 mg(Highnoon Pharma)


501. -do- Duloxa Capsule 20mgEach capsule containsDuloxetine HCL 17.65% enteric coated pellets equivalent to 20 mg Duloxetine Serotonin/Nor epinephrine Re-uptake Inhibitor (Scilife Spec) Source of pellets M/s Surge laboratories Private Limited, Sheikhupura

Form 5Rs. 20,000/- Dy. No.1182 08-06-201614’s,28’s

FDA approved capsule Cymbalta 20 mg manufactured by Lilly

Dulan 20 mg(Hilton Pharma)

Approved

502. -do- Duloxa Capsule 30mgEach capsule contains

Form 5Rs. 20,000/- Dy. No.1181 08-06-2014

FDA approved capsule Cymbalta 30 mg manufactured by

Approved


Duloxetine HCL 17.65% enteric coated pellets equivalent to 30 mg Duloxetine Serotonin/Nor epinephrine Re-uptake Inhibitor (Scilife Spec) Source of pellets M/s Surge laboratories Private Limited, Sheikhupura

14’s,28’s As Per SRO

Lilly

Dulan 30 mg(Hilton Pharma)

503. -do- Duloxa Capsule 60mgEach capsule containsDuloxetine HCL 17.65% enteric coated pellets equivalent to 60 mg Duloxetine Serotonin/Nor epinephrine Re-uptake Inhibitor (Scilife Spec)

Source of pellets M/s Surge laboratories Private Limited, Sheikhupura

Form 5Rs. 20,000/- Dy. No.1180 08-06-201614’s, 28’s As Per SRO

FDA approved capsule Cymbalta 60 mg manufactured by Lilly Dulan 60 mg(Hilton Pharma)

Approved

504. -do- Timsol Capsule 0.4 mg

Each capsule containsTamsulosin HCl 0.2% Pellets equivalent to 0.4 mg Tamsulosin

Peripherally acting anti-adrenergic (Scilife Spec)

Source of pellets M/s Vision Pharmaceuticals, Islamabad

Form 5Rs. 20,000/- Dy. No.1178 08-06-201620’s,30’s As Per SRO

FDA approved capsule Flomax 0.4 mg manufactured by Boehringer Ingelheim

Tamsolin 0.4 mg(Getz Pharma)

Approved

505. -do- Ozon Capsule 20 mgEach capsule contains

Form 5Rs. 20,000/- Rs.80000/- Dy. No.1177 08-

FDA approved capsule Prilosec 20 mg manufactured by

Approved


Omeprazole 12.5% Enteric coated Pellets equivalent to 20 mg Omeprazole

Proton Pump Inhibitor(Scilife Spec)

Source of pellets M/s Spansules Formulation, India

06-2016

14’s,28’s

Astrazeneca Pharma

Risek 20 mg(Getz Pharma)

506. -do- Ozon Capsule 40 mg

Each capsule containsOmeprazole 12.5% Enteric coated Pellets equivalent to 40 mg Omeprazole



Form 5Rs. 20,000/-Rs.80000/- Dy. No.1176 08-06-2016

Pack of 14’s / as per DPC28’s / as per DPC

FDA approved capsule Prilosec 40 mg manufactured by Astrazeneca Pharma

Risek 40 mg(Getz Pharma)

Approved

507. -do- Mebrin MR Capsule 200 mg

Each capsule contains Mebeverine HCl MR 80% Pellets 200 mg

Anti-Spasmodic (Scilife Spec)


Form 5Rs. 20,000/-Rs.80,000/- Dy. No.1179 08-06-201610’s,20’s As Per SRO

MHRA approved capsule Colofac MR manufactured by Abbott

Mebever MR 200 mg(Getz Pharma)

Approved

508. -do- Dexlanz Capsule 30 mg

Each gastro resistant Capsule contains: Dexlansoprazole 22.5% Enteric Coated Pellets…… 30 mg

Form 5Rs. 20,000/- Rs.80,000Dy. No.1205 08-06-201614’s / As Per SRO

USFDA approved capsule Dexilant 30 mg manufactured by Takeda Pharma

Me too needs to be verified.

Deferred for submission of application on Form 5D, requisite fee and


Proton pump Inhibitor(Scilife Spec)


stability data as per guidelines approved by registration Board in 251st

meeting509. -do- Dexlanz Capsule 60

mgEach gastro resistant Capsule contains: Dexlansoprazole 22.5% Enteric Coated Pellets….60 mgProton pump Inhibitor(Scilife Spec) Source of pellets M/s Spansules Formulation, India

Form 5Rs. 20,000/- Rs.80,000/-Dy. No.1204 08-06-201614’s As Per SRO

USFDA approved capsule Dexilant 60 mg manufactured by Takeda Pharma

Me too needs to be verified.

Me too needs to be verified.Invalid GMP certificate attached.

Deferred for submission of application on Form 5D, requisite fee and stability data as per guidelines approved by registration Board in 251st

meeting

Sachet (General)510. Scilife Pharma (Private)

LimitedPlot # FD-57/58-A2, Korangi Creek Industrial park (KCIP) Karachi

Sachet (General) approved in 247st meeting of Central Licensing Board held on 29-04-2016.

Asthiven 4mg SachetEach Sachet containsMontelukast Sodium eq. to Montelukast 4 mg Leukotriene receptor antagonist (Scilife Spec)


FDA Approved SingularMerck (FDA)Solo Powder 4 mgmanufactured by (Atco)

Approved

511. -do- Ozon Insta Powder 20 mg Sachet

Each Sachet containsOmeprazole 20 mgSodium Bicarbonate 1680

Form 5Rs. 20,000/-Dy. No.119608-06-201610’s,30’sAs Per SRO

FDA Approved ZegeridSantarus INC

Risek Insta Powder 20 mg manufactured by (Getz Pharma)

In review in 250th meeting

Deferred as formulation is under


mg (as buffer)


512. -do- Ozon Insta Powder 40 mg SachetEach Sachet containsOmeprazole 40 mgSodium Bicarbonate 1680 mg (as buffer)Proton Pump Inhibitor(Scilife Spec)

Form 5Rs. 20,000/- Dy. No.119503-06-201610’s,30’sAs Per SRO

FDA Approved ZegeridSantarus INC Risek Insta Powder 40 mg manufactured by (Getz Pharma)

International availability discontinue from market. In review in 250th meeting

Deferred as formulation is under. Also confirmation regarding approval status by reference regulatory authorities

513. -do- Forlax SachetEach Sachet containsPEG 3350 …..13.125 gSodium Chloride….0.3507 gSodium bicarbonate….0.1785 gPotassium chloride…0.0466 g

Somatically acting laxatives (Scilife Spec)

Form 5Rs. 20,000/- Dy. No.120108-06-2016


TGA & MHRA Approved Movicol Sachet

Norgine Limited

Movcol manufactured by (Genix Pharma)

Approved

514. -do- Forlax Junior SachetEach Sachet containsPEG 3350 …..6.563 gSodium Chloride….0.1754 gSodium bicarbonate….0.0893 gPotassium chloride…0.0251 g

Somatically acting laxatives (Scilife Spec)

Form 5Rs. 20,000/- Dy. No.1200 08-06-2016)

10’s,20’sAs Per SRO

TGA & MHRA Approved Movicol Junior Sachet

Norgine Limited

Movcol manufactured by (Genix Pharma)

Composition API in me too is different from the product applied for

Sodium Chloride….350.7mgSodium bicarbonat

Deferred for confirmation of composition as per me too


e….178.5mgPotassium chloride…46.6mg

515. -do- Hydro SachetEach Sachet containsAnhydrous Glucose 13.50 gTri sodium citrate Dihydrate 2.90 gSodium Chloride 2.60 gPotassium Chloride 1.50 g

Electrolyte Solution (Anti-diarrheal)

(Scilife Spec)

Form 5Rs. 20,000/- Dy. No.119908-06-2016


Non- Proprietary Oral Rehydration Salt BP

WHO Recommended Formulation

Cellchem Pharmaceutical Incorporation, Canada

Peditral Sachet by M/s Searl Pharma

Composition API in me too is different from the product applied for

Anhydrous Glucose 20 gsodium citrate 2.90gSodium Chloride 3.5g

Approved

516. -do- One soda Sachet

Each Sachet containsSodium Bicarbonate 1.716 gSodium citrate 0.613gCitric acid 0.702 gTartaric acid 0.858 g

Urinary and gastric alkaliniser (Scilife Spec)

Form 5Rs. 20,000/- Dy. No.119708-06-201620’sAs Per SRO

TGA Approved Ural sachet Aspen Pharma

Citro sodamanufactured by (Abbott)

Composition of API in ural sachet is different from the product applied for

Sodium Bicarbonate 1.76 gSodium citrate 0.63gCitric acid 0.72 gTartaric acid 0.89 g

Deferred for confirmation of composition as per me too

517. -do- Mehvisk Sachet

Each Sachet contains

Form 5Rs. 20,000/- Dy. No.1198 08-06-

MHRA Approved Fybogel Mebeverine

Approved


Mebeverine HCl 135 mg Isaphagul husk 3.5 g

Antispasmodic, Anti Constipative (Scilife Spec)

201610’s,20’sAs Per SRO

Forum Health Product Limited

Musk-MSachet manufactured by Genix Pharma )

Evaluator-I Muhammad AnsarAdditional Sections.

Additional section Veterinary



Composition



Type of Form

Initial date, diary




Me-too status



Decision

518. M/s Sanna Laboratories, 1019-B, PSIE, Sargodha Road, Faisalabad.

ATC-Forte Oral water Soluble Powder

Each 100gm contains:-Amoxicillin Trihydrate……50gmColistin Sulphate…….50MIU

Antibacterial


Form 5

Dy No.442 dated 20-05-2016 Rs.20,000.Decontrolled/100gm, 300gm, 500gm, 1kg, 5kg, 10kg & 25kg.

Local. Amox-C Maarson by Attabak.

Approved

519. -do- Himox-50 Oral water Soluble Powder

Each 1000gm contains:-Amoxicillin Trihydrate eq to Amoxicillin……500gm

Antibacterial

Form 5

Dy No.446 dated 20-05-2016 Rs.20,000.

Decontrolled/100gm, 300gm, 500gm, 1kg, 5kg, 10kg & 25kg.

Local. Amoxi-50 by M/s Symans.

Approved


520. -do- Lincosac-200 Oral water Soluble Powder

Each 1000gm contains:-Amoxicillin Trihydrate ……20gmLincomycin HCl……….8.8gmSpectinomycin 2HCl…….8.8gm

Antibacterial


Form 5

Dy No.440 dated 20-05-2016 Rs.20,000.


Local. Amoxy L.S by M/s Inshall.

Approved

521. -do- Clavmox-Forte Oral water Soluble Powder

Each 100gm contains:-Amoxicillin as Amoxicillin Trihydrate ……16gmClavulanic Acid as Potassium Clavulanate……4gmBromhexine HCl…………….0.5gm

Antibacterial


Form 5

Dy No.445 dated 20-05-2016 Rs.20,000.


Local. Wealmox-Plus by M/s Prix.

Approved

522. -do- Clavmox-200 Oral water Soluble Powder

Each 100gm contains:-Amoxicillin as Amoxicillin Trihydrate ……16gmClavulanic Acid as Potassium Clavulanate……4gm

Antibacterial

Form 5

Dy No.441 dated 20-05-2016 Rs.20,000.


Local. Primox-Plus by M/s Prix.

Approved

523. -do- Himox-70 Oral water Soluble Powder

Each 100gm contains:-Amoxicillin Trihydrate 80gm eq to Amoxicillin ……70gm

Antibacterial

Form 5

Dy No.443 dated 20-05-2016 Rs.20,000.


Local. Primox 70% by M/s Prix.

Approved


524. -do- GP-80 Oral water Soluble Powder

Each 1000gm contains:-Zinc Bacitracin ……52gmProcaine Penicillin ……..12gmStreptomycin Sulphate……36gm

Antibacterial

Form 5

Dy No.444 dated 20-05-2016 Rs.20,000.


Local. PSB-100 by M/s Epla.

Approved

M/s Vision Pharma Human Additional section



Composition



Type of Form

Initial date, diary




Me-too status



Decision

525. M/s Vision Pharmaceuticals, Plot No. 22 & 23, Industrial Triangle Kahuta Road, Islamabad.“Liquid Vial General approved in 247th meeting of CLB.”

Linzy 600mg Infusion

Each vial of 300ml contains:-Linezolid……….…..600mg

Antibiotic


Form 5

Dy No. 2713 dated 16-06-2016 Rs.20,000.

As per SRO/1’s

MHRA. Linzolid 2mg/ml by M/s Pfizer

Local. Lezol 600mg by M/s Bosch.

Approved

526. -do- Linzy 400mg Infusion

Each vial of 200ml contains:-Linezolid……….…..400mg

Antibiotic


Form 5

Dy No. 2715 dated 16-06-2016 Rs.20,000.

As per SRO/1’s


Local. Lezol 400mg by M/s Bosch.

Approved

527. -do- Linzy 200mg Infusion

Each vial of 100ml contains:-Linzolid……….…..200mg

Form 5

Dy No. 2714 dated 16-06-2016


Local. Zolrest

Approved


http://druginfosys.com/Brand.aspx?code=21654

Antibiotic


Rs.20,000.

As per SRO/1’s

200mg by M/s Bosch.

528. -do- Katafast 500mg Injection

Each vial of 10ml contains:-Ketamine hydrochloride equivalent to ketamine……….…..500mg

Anesthetic

USP Specifications

Form 5

Dy No. 2704 dated 16-06-2016 Rs.20,000.

As per SRO/1’s

MHRA. Ketalar 50mg/ml by M/s Pfizer

Local. Ketarol 500mg by M/s Global Pharmaceuticals

Approved

529. -do- Odimox 400mg Infusion

Each vial of 100ml contains:-Moxifloxacin hydrochloride equivalent to Moxifloxacin……….…..400mg

Antibiotic


Form 5

Dy No. 2706 dated 16-06-2016 Rs.20,000.

As per SRO/1’s

MHRA. Avelox by M/s Bayer 400mg/250ml

Local. Barimox 400mg by M/s Barrett Hodgson.

Approval status in reference countries not provided.

Advised to apply Form 5 with 250ml

530. M/s Vision Pharmaceuticals, Plot No. 22 & 23, Industrial Triangle Kahuta Road, Islamabad.“Liquid Ampoule General approved in 247th meeting of CLB.”

Artip 40mg Injection

Each ampoule contains:-Artemether……….…..40mg

Antimalarial


Form 5

Dy No. 2703 dated 16-06-2016 Rs.20,000.

As per SRO/1x5’s & 1x10’s

Local. Artem 40mg by M/s Holton Pharma (PVT) Limited

Approved

531. -do- Artip 80mg Injection

Each ampoule of 1 ml contains:-Artemether……….…..80mg

Antimalarial


Form 5

Dy No. 2702 dated 16-06-2016 Rs.20,000.


WHO approved

Local. Artem 80mg by M/s Holton Pharma (PVT) Limited

Approved

532. -do- Feldex 20mg Injection

Each ampoule contains:-Piroxicam……….…..20mg

NSAID


Form 5

Dy No. 2705 dated 16-06-2016 Rs.20,000.

As per

Local. Pcam 20mg by M/s Merck (Pvt) Limited

Approval status in reference countries is not provided.

Deferred for confirmation of approval status by reference regulatory authorities.


SRO/1x5’s & 1x10’s

533. -do- Doston 4mg Injection

Each ampoule of 2ml contains:-Ondansetron hydrochloride equivalent to Ondansetron…….…..4mg

5-HT3 Receptor Antagonist

USP Specifications

Form 5

Dy No. 2771 dated 20-06-2016 Rs.20,000.As per SRO/1x5’s & 1x10’s

MHRA. Zofran by M/s GSK

Local. Ondiemetic 4mg by M/s Zafa Pharmaceuticals

Approved

534. -do- Doston 8mg Injection

Each ampoule 0f 4ml contains:-Ondansetron hydrochloride equivalent to Ondansetron…….…..8mg

5-HT3 Receptor Antagonist

USP Specifications

Form 5

Dy No. 2770 dated 20-06-2016 Rs.20,000.


MHRA. Zofran by M/s GSK

Local. Ondiemetic 8mg by M/s Zafa Pharmaceuticals

Approved

535. -do- Tramax 50mg Injection

Each ampoule of 1ml contains:-Tramadol hydrochloride equivalent to Tramadol…….…..50mg

Opioid analgesic

USP Specifications

Form 5

Dy No. 2710 dated 16-06-2016 Rs.20,000.


MHRA. Tramadol by M/s Beacon

Local. Tramal 50mg by M/s Searle Pakistan (Pvt) Limited.

Approved

536. -do- Spasmax Plus Injection

Each ampoule contains:-Phloroglucinol dehydrate equivalent to Phloroglucinol…….40mgTrimethylphloroglucinol….0.04mg

Antispasmodic


Form 5

Dy No. 2774 dated 20-06-2016 Rs.20,000.


Local. Spadix by M/s Tabros Pharma.

The product is under review.

Deferred as product is under review.

537. -do- Zytec 25mg Injection

Each ampoule of 1ml contains:-Ranitidine hydrochloride equivalent to Ranitidine…….25mg

Histamine H2 receptor blocker

USP Specifications

Form 5

Dy No. 2702 dated 16-06-2016 Rs.20,000.


MHRA. Ranitidine 25mg/ml by M/s Amdipharm

Local. Ranitidine injection 25mg by M/s Glaxosmithkline

Approved

538. -do- Pyritec 150mg Injection Form 5 Deferred for confirmation


Each ampoule 1ml contains:-Paracetamol………….150mg

Analgesic & antipyretic


Dy No. 2712 dated 16-06-2016 Rs.20,000.


Local. Pravos 150mg injection by M/s Sami Pharmaceuticals (Pvt) Limited.

of approval status by reference regulatory authorities.

539. -do- Etorac 10mg Injection

Each ampoule of ml contains:-Ketorolac tromethamine equivalent to Ketorolac………….10mg

NSAID

USP Specifications

Form 5

Dy No. 2049 dated 26-05-2016 Rs.20,000.


MHRA

Local. Toradol 10mg injection by M/s Roche Pakistan Limited.


540. -do- Etorac 30mg Injection

Each ampoule of 1ml contains:-Ketorolac tromethamine equivalent to Ketorolac………….30mg

NSAID

USP Specifications

Form 5

Dy No. 2048 dated 26-05-2016 Rs.20,000.


MHRA. Ketoralac 30mg/ml by M/s Beacon

Local. Toradol 30mg injection by M/s Roche Pakistan Limited.

Approved

541. -do- Drotin 40mg Injection

Each ampoule of 2ml contains:-Drotaverine hydrochloride equivalent to Drotaverine.……….40mg

Antispasmodic


Form 5

Dy No. 2709 dated 16-06-2016 Rs.20,000.


Local. NO-SPA 40mg injection by M/s Sanofi Aventis (Pakistan) Limited.

Approved

542. -do- Osteo-D 5mg Injection

Each ampoule of 1ml contains:-Cholecalciferol….……….5mg

Vitamin

BP Specifications

Form 5

Dy No. 2047 dated 26-05-2016 Rs.20,000.


Local. Calciferol 5mg injection by M/s Global Pharmaceuticals.

Approved

543. M/s Vision Pharmaceuticals, Plot No. 22 & 23, Industrial Triangle Kahuta Road, Islamabad.

Indocin 1mg Injection

Each vial contains:-Indomethacin sodium ready to fill powder equivalent to Indomethacin….……….1mg

Form 5

Dy No. 2711 dated 16-06-2016 Rs.20,000.

FDA approved

Local. Liometacen Injection by M/s Chiesi Pharmaceuticals (Pvt) Limited.

Deferred as product is more than 10.


“Sterile Dry Powder Inectable Vials General approved in 240th meeting of CLB.”

NSAID

USP Specifications

As per SRO/1’s

544. -do- Viscortin 100mg Injection

Each vial contains:-Hydrocortisone sodium succinate ready to fill powder equivalent to Hydrocortisone ….……….100mg

Glucocorticoid

USP Specifications

Form 5

Dy No. 2050 dated 26-05-2016 Rs.20,000.

As per SRO/1’s

FDA approved

Local. Hy-cortisone 100mg Injection by M/s Cirin Pharmaceuticals (Pvt) Limited.

Approved



Glucocorticoid

USP Specifications

Form 5

Dy No. 2051 dated 26-05-2016 Rs.20,000.

As per SRO/1’s

FDA approved


Approved



Glucocorticoid

USP Specifications

Form 5

Dy No. 2052 dated 26-05-2016 Rs.20,000.

As per SRO/1’s

FDA approved


Approved

547. -do- Vanacin 500mg Injection

Each vial contains:-Vancomycin hydrochloride ready to fill powder equivalent to Vancomycin….. ….……….500mg

Antibiotic

USP Specifications

Form 5

Dy No. 2056 dated 26-05-2016 Rs.20,000.

As per SRO/1’s

MHRA. Vancomycin 500mg by M/s Actavis

Local. Vinjec 500mg Injection by M/s Bosch Pharmaceuticals (Pvt) Limited.

Approved

548. -do- Vanacin 1g Injection

Each vial contains:-Vancomycin hydrochloride ready to fill powder equivalent to Vancomycin….. ….……….1g

Form 5

Dy No. 2055 dated 26-05-2016 Rs.20,000.

MHRA. Vancomycin 1g by M/s Actavis

Local. Vinjec 1g Injection by M/s Bosch

Approved


Antibiotic

USP Specifications

As per SRO/1’s

Pharmaceuticals (Pvt) Limited.

549. -do- Methlone 500mg Injection

Each vial contains:-Methylprednisolone sodium succinate ready to fill powder equivalent to Methylprednisolone ….……….500mg

Glucocorticoid

USP Specifications

Form 5

Dy No. 2053 dated 26-05-2016 Rs.20,000.

As per SRO/1’s

MHRA. Methylprednisolone Powder for injection by M/s Beacon.

Local. Methylpred 500mg Injection by M/s Haji medicine co.

Approved

550. -do- Methlone 1g Injection

Each vial contains:-Methylprednisolone sodium succinate ready to fill powder equivalent to Methylprednisolone ….……….1g

Glucocorticoid

USP Specifications

Form 5

Dy No. 2054 dated 26-05-2016 Rs.20,000.

As per SRO/1’s

MHRA. Methylprednisolone Powder for injection by M/s Beacon.

Local. Methylpred 1g Injection by M/s Haji medicine co.

Approved

551. -do- Tigelin 50mg Injection

Each vial contains:-Tigecycline ready to fill powder equivalent to Tigecycline…….……….50g

Antibiotic


Form 5

Dy No. 2708 dated 16-06-2016 Rs.20,000.

As per SRO/1’s

MHRA. Tygacil 50mg Powder for infusion by M/s Pfizer

Local. Tigecycline 50mg Injection by M/s Wyeth Pakistan Limited.

Approved

552. M/s Vision Pharmaceuticals, Plot No. 22 & 23, Industrial Triangle Kahuta Road, Islamabad.“Tablet General approved in 240th meeting of CLB.”

Galmet 50mg/500mg Tablet

Each film coated tablet contains:-Vildagliptin….………...50mgMetformin hydrochloride equivalent to Metformin………..…500mg

Antidiabetic


Form 5

Dy No. 2714 dated 16-06-2016 Rs.20,000.

As per SRO/2x7’s

TGA. Sobrea by M/s Novartis

Local. Galvusmet 50mg/500mg Tablet by M/s Novartis Pharma (Pak) Limited.

Approved

553. -do- Galmet 50mg/850mg Tablet


Antidiabetic

Form 5

Dy No. 2717 dated 16-06-2016 Rs.20,000.

As per SRO/2x7’s

MHRA. Eucrease by M/s Novartis


Approved


Manufacturer’s Specifications554. -do- Galmet 50mg/1000mg Tablet


Antidiabetic


Form 5

Dy No. 2716 dated 16-06-2016 Rs.20,000.

As per SRO/2x7’s

MHRA. Eucrase by M/s Novartis


Approved

555. -do- Valent-H 80mg/12.5mg Tablet

Each film coated tablet contains:-Valsartan….………...80mghydrochlorothiazide…….…12.5mg

Calcium Channel Blocker + Diuretic

USP Specifications

Form 5

Dy No. 2773 dated 20-06-2016 Rs.20,000.

As per SRO/2x7’s

MHRA. Co-Diovan by M/s Novartis.

Local. Co-Diavan 80mg/12.5mg Tablet by M/s Novartis Pharma (Pak) Limited.

Approved

556. -do- Valent-H 160mg/12.5mg Tablet

Each film coated tablet contains:-Valsartan….………...160mghydrochlorothiazide…….…12.5mg


USP Specifications

Form 5

Dy No. 2772 dated 20-06-2016 Rs.20,000.

As per SRO/2x7’s

MHRA. Co-Diovan by M/s Novartis

Local. Co-Diavan 160mg/12.5mg Tablet by M/s Novartis Pharma (Pak) Limited.

Approved

557. -do- Valent-H 160mg/25mg Tablet

Each film coated tablet contains:-Valsartan….………...160mgHydrochlorothiazide…….…25mg


USP Specifications

Form 5

Dy No. 2775 dated 20-06-2016 Rs.20,000.

As per SRO/2x7’s

MHRA. Co-Diovan by M/s Novartis

Local. Co Valtec 160mg/25mg Tablet by M/s Tabros Pharma.

Approved

558. -do- Co-Valzaar 5mg/80mg Tablet

Each film coated tablet contains:-Amlodipine….………...5mgValsartan………….…80mg

Angiotensin Receptor Blocker + Calcium Channel Blocker

USP Specifications

Form 5

Dy No. 2768 dated 20-06-2016 Rs.20,000.

As per SRO/2x7’s

MHRA. Exforge by M/s Novartis

Local. Amstan 5mg/80mg Tablet by M/s Getz Pharma (Pvt) Limited.

Approved

559. -do- Co-Valzaar 5mg/160mg Tablet Form 5 MHRA. Exforge Approved




USP Specifications

Dy No. 2766 dated 20-06-2016 Rs.20,000.

As per SRO/2x7’s

by M/s Novartis





USP Specifications

Form 5

Dy No. 2767 dated 20-06-2016 Rs.20,000.

As per SRO/2x7’s






USP Specifications

Form 5

Dy No. 2769 dated 20-06-2016 Rs.20,000.

As per SRO/2x7’s

MHRA. Exforge by M/s Novartis


Approved




USP Specifications

Form 5

Dy No. 2765 dated 20-06-2016 Rs.20,000.

As per SRO/2x7’s



563. -do- Spasmax 40mg Injection

Each ampoule of 4ml contains:-Phloroglucinol dehydrate equivalent to Phloroglucinol…….40mg

Antispasmodic


Form 5

Dy No. 2848 dated 23-06-2016 Rs.20,000.


Local. Spasfon by M/s Hilton Pharma (Pvt) Limited.

The product is under review

Deferred as the product is under review

564. -do- Nalfy Injection 20mg

Each 01ml ampoule contains:Nalbuphine Hydrochloride eq. to Nalbuphine………20mg

Form 5

Dy No. 2849 dated 23-06-2016 Rs.20,000.

FDA Nubail by M/s Endo

Local. Nalbin 20mg by M/s Global

Approved


Opioid

(Manufacturer’s Specifications )


Pharmaceuticals.

565. -do- Nalfy Injection 10mg

Each 01ml ampoule contains:Nalbuphine Hydrochloride eq. to Nalbuphine………10mg

Opioid

(Manufacturer’s Specifications )

Form 5

Dy No. 2850 dated 23-06-2016 Rs.20,000.


FDA Nubail by M/s Endo

Local. Nalbin 10mg by M/s Global Pharmaceuticals.

Approved

Remaining applications of M/s Sami Pharma, Karachi

566. M/s SAMI Pharmaceuticals (Pvt.) Limited, F-95, Off. Hub River Road, S.I.T.E., Karachi-75730

(Tablet General)

ROSERA 5mg Tablets

Each film coated tablet contains:Rosuvastatin Calcium MS equivalent to Rosuvastatin ………………………..5mg

HMG Reductase Inhibitor

Manufacturer’s Specs.

Form 5

Rs. 20,000/-(06-01-2014)

As per SRO

EMA: Crestor (AstraZeneca)FDA: Crestor (AstraZeneca)

Rovista Regn. No. 044043 (M/s Getz)

Fee Rs 20,000 is a photocopy.

Approved. Fee will be verified by Budget and Accounts, DRAP & Chairman Registration Board will permit issuance of registration letter.


(Tablet General)

ROSERA 10mg Tablets




Form 5Rs. 20,000/-(06-01-2014)

As per SRO




Approved. Fee will be verified by Budget and Accounts, DRAP & Chairman Registration Board will permit issuance of registration letter.


(Tablet General)

ROSERA 20mg Tablets




Form 5Rs. 20,000/-(06-01-2014)

As per SRO




Approved. Fee will be verified by Budget and Accounts, DRAP & Chairman Registration Board will permit issuance of


registration letter.


(Freeze Dried Products General)

Lenor 8mg InjectionEach combination pack contain:Vial: Lornoxicam MS……….…8mg

Ampoule:Water for Injection USP……….2ml



Form 5

Dy No.206 dated 01-06-2015 Rs. 20,000/-

As per SRO

Acabel Reg. No. 061605 (M/s Continental Pharma)

Approval status in reference countries is not provided.



Evaluator-IV Salateen Waseem PhilpNew License & New Sections Cases.

New License





Me-too status

GMP status


Decision

570. SURGILINE A business division of the licensed unit M/s Vikor Healthcare (Pvt.) Ltd, Plot # C-126 to C-135, LIEDA, Hub District, Lasbella, Balouchistan

Silk Braided

Silk Braided sterile non absorbable surgical suture (all sizes with all types of needles as per USP)

Sutures, Non absorbable silkUSP Specification


Pack size of 12 pieces

Mersilk –Ethicon, UK

Ethicon mersilk-Johnson & Johnson (import)

DML # 000834Silk Suture Section

Source of Raw braided silk Pearsalls Limited, London

Source of needles :-Enova® 300 needles, a brand of Suturex & RenodexSurgical Needles, France

Sterilization :- By Gamma irradiations

Deferred for following clarification: Docum

entary / regulatory references for source of braided silk and needle.

Method of gamma radiations and agreement.

Sterility testing facility

Demanded Price & Pack size# Siz Length Curvature Length Point Unit Pack size Price


e / Gauge

s

price per pack

1) 2 76 cm ½ circle 40 mm Round bodies heavy 191.59 12 2299.082) 1 76 cm ½ circle 35 mm Taper point 181.82 12 2181.783) 1 76 cm Curved 60 mm Curved cutting 181.82 12 2181.784) 1 76 cm ½ circle 30 mm Round bodies heavy 181.82 12 2181.785) 1 76 cm Straight 60 mm Cutting 181.82 12 2181.786) 0 76 cm ½ circle 30 mm Taper point 175.95 12 2111.407) 0 76 cm ½ circle 50 mm Cutting 175.95 12 2111.408) 0 76 cm Straight 60 mm Cutting 175.95 12 2111.409) 0 1m Straight 75 mm Cutting 175.95 12 2111.4010) 0 76 cm Curved 45 mm Reverse cutting 175.95 12 2111.4011) 2/0 45 cm Curved 26 mm Reverse cutting 166.18 12 1994.1012) 2/0 76 cm ½ circle 26 mm Taper point 166.18 12 1994.1013) 2/0 76 cm ½ circle 30 mm Taper point 166.18 12 1994.1014) 2/0 76 cm Curved 16 mm Curved cutting 166.18 12 1994.1015) 2/0 45 cm ½ circle 22 mm cutting 166.18 12 1994.1016) 2/0 76 cm ½ circle 40 mm Taper point 166.18 12 1994.1017) 2/0 76 cm Curved 35 mm Reverse cutting 166.18 12 1994.1018) 2/0 1m Straight 75 mm Cutting 166.18 12 1994.1019) 2/0 1m Straight 55 mm Cutting 166.18 12 1994.1020) 2/0 45 cm Curved 26 mm Precision cutting 166.18 12 1994.1021) 2/0 76 cm Curved 35 mm Precision cutting 166.18 12 1994.1022) 2/0 45 cm ½ circle 25 mm taper point 166.18 12 1994.1023) 3/0 45 cm Curved 26 mm Reverse cutting 150.54 12 1806.4224) 3/0 76 cm Curved 16 mm Curved cutting 150.54 12 1806.4225) 3/0 45 cm Curved 25 mm Slim blade 150.54 12 1806.4226) 3/0 45 cm 3/8 circle 26 mm Conventional cutting 150.54 12 1806.4227) 3/0 76 cm ½ circle 16 mm Taper point 150.54 12 1806.4228) 3/0 76 cm ½ circle 25 mm Taper point 150.54 12 1806.4229) 3/0 76 cm ½ circle 30 mm Taper point 150.54 12 1806.4230) 3/0 76 cm 5/8 circle 25 mm Cutting 150.54 12 1806.4231) 3/0 45 cm ½ circle 22 mm Cutting 150.54 12 1806.4232) 3/0 76 cm ½ circle 35 mm Taper point 150.54 12 1806.4233) 3/0 76 cm ½ circle 20 mm Taper point 150.54 12 1806.4234) 3/0 76 cm Curved 20 mm Taper point 150.54 12 1806.4235) 3/0 45 cm Curved 15 mm Slim blade 150.54 12 1806.4236) 3/0 76 cm Straight 60 mm Straight cutting 150.54 12 1806.4237) 3/0 76 cm Curved 35 mm Reverse cutting 150.54 12 1806.4238) 3/0 45 cm Curved 20 mm Slim blade 150.54 12 1806.4239) 3/0 1m Straight 75 mm Cutting 150.54 12 1806.4240) 3/0 45 cm Curved 16 mm Precision cutting 150.54 12 1806.4241) 3/0 45 cm Curved 19 mm Precision cutting 150.54 12 1806.4242) 3/0 45 cm Curved 22 mm Precision cutting 150.54 12 1806.4243) 3/0 45 cm Curved 26 mm Precision cutting 150.54 12 1806.4244) 3/0 76 cm Curved 35 mm Precision cutting 150.54 12 1806.4245) 3/0 45 cm ½ circle 16 mm Taper point 150.54 12 1806.42


46) 4/0 45 cm Curved 19 mm Reverse cutting 150.54 12 1806.4247) 4/0 76 cm Curved 16 mm Curved cutting 150.54 12 1806.4248) 4/0 45 cm ½ circle 15 mm Slim blade 150.54 12 1806.4249) 4/0 45 cm Curved 25 mm Slim blade 150.54 12 1806.4250) 4/0 76 cm ½ circle 16 mm Taper point 150.54 12 1806.4251) 4/0 76 cm Curved 16 mm Taper point 150.54 12 1806.4252) 4/0 76 cm ½ circle 20 mm Taper point 150.54 12 1806.4253) 4/0 45 cm Curved 15 mm Slim blade 150.54 12 1806.4254) 4/0 45 cm Curved 20 mm Slim blade 150.54 12 1806.4255) 4/0 45 cm Curved 13 mm Reverse cutting 150.54 12 1806.4256) 4/0 45 cm Curved 16 mm Precision cutting 150.54 12 1806.4257) 4/0 45 cm Curved 19 mm Precision cutting 150.54 12 1806.4258) 4/0 45 cm curved 26 mm Precision cutting 150.54 12 1806.42


Surgigut plain

Plain sterile absorbable surgical sutures (all sizes)

Catgut plain sterile absorbable surgical sutures USP Specification



Softcat plain BBRAUN USA

Catgut – Ethicon (Import)

DML # 000834Catgut sutures (absorbable) Section

Source of Catgut plain stringLocally manufactured at Vikor Healthcare (Pvt.) Ltd under license of basic manufacturing DML # 000835.

Source of needles :-Enova® 300 needles, a brand of Suturex & RenodexSurgical Needles, France

Sterilization :- By Gamma irradiations


entary / regulatory references for source of needle.

Method of gamma radiations and agreement.

Sterility testing facility.

Source of catgut material



Surgigut Chromic

Catgut chromic sterile absorbable surgical suture (all sizes)

Catgut sterile absorbable surgical sutures USP Specification



Softcan Chrom – BBRAUN, USA

Catgut – Ethicon (Import)

DML # 000834Catgut sutures (absorbable) Section

Source of Catgut plain stringLocally manufactured at Vikor Healthcare (Pvt.) Ltd under license of basic manufacturing DML # 000835.Source of needles :-Enova® 300 needles, a brand of Suturex & RenodexSurgical Needles, France Sterilization :- By Gamma irradiations


entary / regulatory references for source of needle.

Method of gamma radiations and agreem


Demanded Price & Pack size# Size /

GaugesLength Curvature Length Point Unit price Pack size Price per

pack1) 1 76 cm ½ circle 40 mm Reverse Cutting 211.14 12 2533.682) 1 76 cm ½ circle 40 mm Taper point 211.14 12 2533.683) 1 76 cm ½ circle 30 mm Taper point 211.14 12 2533.684) 0 76 cm ½ circle 36 mm Taper point 211.14 12 2533.685) 0 76 cm ½ circle 35 mm Taper point 191.59 12 2299.086) 0 76 cm Curved 26 mm Curved cutting 191.59 12 2299.087) 0 76 cm ½ circle 40 mm Taper point 191.59 12 2299.088) 2/0 76 cm ½ circle 30 mm Taper point 191.59 12 2299.089) 2/0 76 cm ½ circle 30 mm Taper point 181.82 12 2181.7810) 2/0 76 cm ½ circle 25 mm Taper point 181.82 12 2181.7811) 2/0 76 cm ½ circle 35 mm Taper point 181.82 12 2181.7812) 2/0 76 cm Curved 26 mm Curved cutting 181.82 12 2181.7813) 2/0 76 cm Straight 38 mm Straight cutting 181.82 12 2181.7814) 2/0 76 cm ½ circle 30 mm cutting 181.82 12 2181.7815) 3/0 76 cm ½ circle 20 mm Taper Point 168.13 12 2017.5616) 3/0 76 cm ½ circle 26 mm Taper point 168.13 12 2017.5617) 3/0 76 cm Curved 22 mm Curved cutting 168.13 12 2017.5618) 3/0 76 cm ½ circle 16 mm Cutting 168.13 12 2017.5619) 3/0 76 cm Curved 26 mm Curved Cutting 168.13 12 2017.5620) 3/0 76 cm Curved 16 mm Curved cutting 168.13 12 2017.5621) 3/0 76 cm ½ circle 30 mm Taper point 168.13 12 2017.5622) 4/0 76 cm Curved 16 mm Curved cutting 168.13 12 2017.5623) 4/0 76 cm Curved 16 mm Taper point 168.13 12 2017.56

ent. Sterilit

y testing facility.

Source of catgut material




GaugesLength Curvature Length Point Unit

pricePack size Price per

pack1) 2 76 cm ½ circle Heavy 35 mm Taper cut 232.65 12 2791.742) 2 76 cm ½ circle Heavy 45 mm Taper cut 232.65 12 2791.743) 2 76 cm ½ circle Heavy 40 mm Taper point 232.65 12 2791.744) 2 76 cm ½ circle Heavy 45 mm Taper point 232.65 12 2791.745) 2 76 cm ½ circle 50 mm Taper point 232.65 12 2791.746) 2 76 cm ½ circle 40 mm Reverse cutting 232.65 12 2791.747) 2 76 cm ½ circle 50 mm Reverse cutting 232.65 12 2791.748) 2 76 cm ½ circle 65 mm Taper point 232.65 12 2791.749) 2 76 cm ½ circle Heavy 40 mm Trocar point 232.65 12 2791.7410) 2 76 cm ½ circle Heavy 45 mm Trocar point 232.65 12 2791.7411) 2 76 cm ½ circle Heavy 80 mm Taper cut 232.65 12 2791.7412) 1 76 cm Curved 45 mm Taper point 220.92 12 2650.9813) 1 76 cm ½ circle 50 mm Taper point 220.92 12 2650.9814) 1 76 cm ½ circle 38 mm Taper point 220.92 12 2650.9815) 1 76 cm Curved 63 mm Blunt pint round bodied 220.92 12 2650.9816) 1 76 cm Curved 85 mm Blunt pint round bodied 220.92 12 2650.9817) 1 76 cm ½ circle Heavy 35 mm Taper cut 220.92 12 2650.9818) 1 76 cm ½ circle Heavy 45 mm Taper cut 220.92 12 2650.9819) 1 76 cm ½ circle 40 mm Taper cut 220.92 12 2650.9820) 1 76 cm ½ circle 30 mm Taper cut 220.92 12 2650.9821) 1 76 cm ½ circle Heavy 30 mm Taper point 220.92 12 2650.9822) 1 76 cm ½ circle Heavy 45 mm Taper point 220.92 12 2650.9823) 1 76 cm Curved 30 mm Taper point 220.92 12 2650.9824) 1 76 cm ½ circle 40 mm Taper point 220.92 12 2650.9825) 1 76 cm ½ circle 40 mm Reverse cutting 220.92 12 2650.9826) 1 76 cm ½ circle 50 mm Reverse cutting 220.92 12 2650.9827) 1 76 cm ½ circle 65 mm Taper point 220.92 12 2650.9828) 1 76 cm ½ circle Heavy 30 mm Trocar point 220.92 12 2650.9829) 1 76 cm ½ circle Heavy 35 mm Trocar point 220.92 12 2650.9830) 1 76 cm ½ circle Heavy 40 mm Trocar point 220.92 12 2650.9831) 1 76 cm ½ circle Heavy 45 mm Trocar point 220.92 12 2650.9832) 1 76 cm ½ circle Heavy 80 mm Taper cut 220.92 12 2650.9833) 0 76 cm Straight 40 mm Taper point 211.14 12 2533.6834) 0 76 cm Curved 30 mm Taper point 211.14 12 2533.6835) 0 76 cm Curved 40 mm Taper point 211.14 12 2533.6836) 0 76 cm Curved 45 mm Taper point 211.14 12 2533.6837) 0 76 cm Curved 65 mm Taper point 211.14 12 2533.6838) 0 76 cm ½ circle 35 mm Taper point 211.14 12 2533.6839) 0 76 cm ½ circle 45 mm Taper point 211.14 12 2533.6840) 0 76 cm ½ circle 50 mm Taper point 211.14 12 2533.6841) 0 76 cm ½ circle 60 mm Taper point 211.14 12 2533.6842) 0 76 cm 5/8 circle 35 mm Taper point 211.14 12 2533.6843) 0 76 cm ½ circle 35 mm Taper cut 211.14 12 2533.6844) 0 76 cm ½ circle 30 mm Taper cut 211.14 12 2533.6845) 0 76 cm ½ circle 30 mm Taper point 211.14 12 2533.6846) 0 76 cm ½ circle 40 mm Taper point 211.14 12 2533.6847) 0 76 cm ½ circle 45 mm Cutting 211.14 12 2533.6848) 0 76 cm Hook needle 35 mm Round bodied 211.14 12 2533.6849) 2/0 76 cm Straight 40 mm Taper point 191.59 12 2299.0850) 2/0 76 cm Straight 50 mm Taper point 191.59 12 2299.0851) 2/0 76 cm Curved 30 mm Taper point 191.59 12 2299.0852) 2/0 76 cm Curved 40 mm Taper point 191.59 12 2299.08

573. M/s MEDIPAK LIMITED, 554, Sundar Industrial Estate, Lahore.

(Intravenous infusion) approved in 247 th meeting of CLB held on 29.04.16

Medisol NS IV Infusion- B.P-

Each 100ml contains.Sodium Chloride….. 0.9gWater for Injection q.s 100ml

Electrolytes(B.P Specification)

FORM 5 Rs 20,000/-24.05.16

Pack size 100mlplus Eurocap price with single & double injection portsPrice As per SRO

Sodium Chloride 0.9% IV infusion BP (Baxter Health care Limited (UK)

Sterifluid NS (FDL Limited)

DML Inspection dated 16.03.16

Deferred for provision of approval status of formulation in same pack size by reference regulatory authorities.

574. -do- Medisol NS IV Infusion- B.P-

Each 100ml contains.Sodium Chloride...... 0.9gWater for Injection q.s 100ml

Electrolytes

(B.P Specs)

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 250ml

Price =As per SRO plus Eurocap price with single & double injection ports




Deferred for provision of approval status of formulation in same pack size by reference regulatory authorities.


Each 100ml contains.Sodium Chloride.......0.9gWater for Injection q.s 100ml

Electrolytes

(B.P Specs)

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 500ml





Approved


Each 100ml contains.Sodium Chloride......0.9gWater for Injection q.s 100ml

Electrolytes

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 1000ml




DML

Approved



GaugesLength Curvature Length Point Unit

pricePack size Price per

pack1) 2 76 cm ½ circle Heavy 35 mm Taper cut 232.65 12 2791.742) 2 76 cm ½ circle Heavy 45 mm Taper cut 232.65 12 2791.743) 2 76 cm ½ circle Heavy 40 mm Taper point 232.65 12 2791.744) 2 76 cm ½ circle Heavy 45 mm Taper point 232.65 12 2791.745) 2 76 cm ½ circle 50 mm Taper point 232.65 12 2791.746) 2 76 cm ½ circle 40 mm Reverse cutting 232.65 12 2791.747) 2 76 cm ½ circle 50 mm Reverse cutting 232.65 12 2791.748) 2 76 cm ½ circle 65 mm Taper point 232.65 12 2791.749) 2 76 cm ½ circle Heavy 40 mm Trocar point 232.65 12 2791.7410) 2 76 cm ½ circle Heavy 45 mm Trocar point 232.65 12 2791.7411) 2 76 cm ½ circle Heavy 80 mm Taper cut 232.65 12 2791.7412) 1 76 cm Curved 45 mm Taper point 220.92 12 2650.9813) 1 76 cm ½ circle 50 mm Taper point 220.92 12 2650.9814) 1 76 cm ½ circle 38 mm Taper point 220.92 12 2650.9815) 1 76 cm Curved 63 mm Blunt pint round bodied 220.92 12 2650.9816) 1 76 cm Curved 85 mm Blunt pint round bodied 220.92 12 2650.9817) 1 76 cm ½ circle Heavy 35 mm Taper cut 220.92 12 2650.9818) 1 76 cm ½ circle Heavy 45 mm Taper cut 220.92 12 2650.9819) 1 76 cm ½ circle 40 mm Taper cut 220.92 12 2650.9820) 1 76 cm ½ circle 30 mm Taper cut 220.92 12 2650.9821) 1 76 cm ½ circle Heavy 30 mm Taper point 220.92 12 2650.9822) 1 76 cm ½ circle Heavy 45 mm Taper point 220.92 12 2650.9823) 1 76 cm Curved 30 mm Taper point 220.92 12 2650.9824) 1 76 cm ½ circle 40 mm Taper point 220.92 12 2650.9825) 1 76 cm ½ circle 40 mm Reverse cutting 220.92 12 2650.9826) 1 76 cm ½ circle 50 mm Reverse cutting 220.92 12 2650.9827) 1 76 cm ½ circle 65 mm Taper point 220.92 12 2650.9828) 1 76 cm ½ circle Heavy 30 mm Trocar point 220.92 12 2650.9829) 1 76 cm ½ circle Heavy 35 mm Trocar point 220.92 12 2650.9830) 1 76 cm ½ circle Heavy 40 mm Trocar point 220.92 12 2650.9831) 1 76 cm ½ circle Heavy 45 mm Trocar point 220.92 12 2650.9832) 1 76 cm ½ circle Heavy 80 mm Taper cut 220.92 12 2650.9833) 0 76 cm Straight 40 mm Taper point 211.14 12 2533.6834) 0 76 cm Curved 30 mm Taper point 211.14 12 2533.6835) 0 76 cm Curved 40 mm Taper point 211.14 12 2533.6836) 0 76 cm Curved 45 mm Taper point 211.14 12 2533.6837) 0 76 cm Curved 65 mm Taper point 211.14 12 2533.6838) 0 76 cm ½ circle 35 mm Taper point 211.14 12 2533.6839) 0 76 cm ½ circle 45 mm Taper point 211.14 12 2533.6840) 0 76 cm ½ circle 50 mm Taper point 211.14 12 2533.6841) 0 76 cm ½ circle 60 mm Taper point 211.14 12 2533.6842) 0 76 cm 5/8 circle 35 mm Taper point 211.14 12 2533.6843) 0 76 cm ½ circle 35 mm Taper cut 211.14 12 2533.6844) 0 76 cm ½ circle 30 mm Taper cut 211.14 12 2533.6845) 0 76 cm ½ circle 30 mm Taper point 211.14 12 2533.6846) 0 76 cm ½ circle 40 mm Taper point 211.14 12 2533.6847) 0 76 cm ½ circle 45 mm Cutting 211.14 12 2533.6848) 0 76 cm Hook needle 35 mm Round bodied 211.14 12 2533.6849) 2/0 76 cm Straight 40 mm Taper point 191.59 12 2299.0850) 2/0 76 cm Straight 50 mm Taper point 191.59 12 2299.0851) 2/0 76 cm Curved 30 mm Taper point 191.59 12 2299.0852) 2/0 76 cm Curved 40 mm Taper point 191.59 12 2299.08

(B.P Specs) Inspection dated 16.03.16

577. -do- Ciprofena IV Infusion B.P

Each 100ml contains.Ciprofloxacin as lactate....200mg

Antibiotic(B.P Specs)

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 100ml


Ciprofloxacin solution for Infusion (MHRA)

Ciproxin IV Infusion (Bayer Healthcare)


Approved

578. -do- Ciprofena IV Infusion B.P

Each 100ml contains.Ciprofloxacin as lactate....200mgWater for Injection q.s ....100ml

Antibiotic(B.P Specs)

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 250mlplus Eurocap price with single & double injection portsPrice =As per SRO

Ciprofloxacin solution for Infusion (MHRA)

Ciproxin IV Infusion (Bayer Healthcare)


Deferred for provision of approval status of formulation in same pack size by reference regulatory authorities and Pakistan.

579. Aquasteril -water for injection)BP-

Each 100ml contains.Water for Injection 100ml Diluent for Admixing

(BP Specs)

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 100ml


Water for Injection Antigen International Ltd Auckland-New Zeeland (MHRA)

Water for injection (Otsuka Pvt Limited)

Deferred for provision of approval status of formulation in same pack size by reference regulatory authorities and Pakistan and with intended use in this pack size.

580. Aquasteril -water for injection)BP-

Each 100ml contains.

FORM 5 Rs 20,000/-24.05.16 ,

Water for Injection Antigen International

Deferred for provision of approval


Water for Injection 100ml

Diluent for Admixing

(BP Specs)

Pack size 250ml


Ltd Auckland-New Zeeland (MHRA)


status of formulation in same pack size by reference regulatory authorities and Pakistan and with intended use in this pack size.

581. Aquasteril (water for injection)BP-

Each 100ml contains.Water for Injection 100ml


(BP Specs)

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 500ml





582. Aquasteril (water for injection)BP-

Each 100ml contains.Water for Injection 100ml


(BP Specs)

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 1000ml






583. Medisol 5% IV Infusion—B.P

Each 100ml contains.Dextrose Anhydrous....5gWater for Injection q.s ....100ml

Carbohydrates

(B.P Specs)

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 100ml


Dextrose IV Infusion (B. Braun)

Sterifluid -5 (FDL Limited)DML Inspection dated 16.03.16

Deferred for provision of approval status of formulation in same pack size by reference regulatories authorities and Pakistan.



Carbohydrates(B.P Specs)

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 250ml



Sterifluid -5 (FDL Limited)




Carbohydrates

(B.P Specs)

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 500ml





Approved



Carbohydrates

(B.P Specs)

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 1000ml





Approved


587. Medigyl Injection B.P – Each 100ml contains.Metronidazole....0.5gWater for Injection q.s ....100ml

Anti amoebic

(B.P Specs)

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 100ml


Metronidazole Infusion AFT Pharma New Zeeland

Flagyl Injection (Sanofi)


Approved

588. Medigyl Injection B.P –

Each 100ml contains.Metronidazole....0.5gWater for Injection q.s ....100ml

Anti amoebic

(B.P Specs)

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 250ml


Metronidazole Infusion AFT Pharma New Zeeland

Flagyl Injection (Sanofi)



589. Medisol-S IV Infusion—B.P

Each 100ml contains.1. Sodium Chloride...0.9g2. Dextrose Anhydrous...5g3. Water for Injection Q.S.

Electrolytes + carbohydrates

B.P specs

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 100ml


Sterifluid 0.9% Glucose 5%Baxter Healthcare Ltd-UK)

Sterifluid DS (FDL)




Each 100ml contains.1. Sodium Chloride...0.9g2. Dextrose Anhydrous...5g3. Water for Injection

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 250ml

Price =As per SRO plus Eurocap price with single & double


Sterifluid DS (FDL)

Deferred for provision of approval status of formulation in same pack size by


Q.S.


B.P specs

injection ports DML Inspection dated 16.03.16

reference regulatories authorities and Pakistan.




B.P specs

FORM 5 Rs 20,000/-24.05.16

Pack size 500ml



Sterifluid DS (FDL)


Approved




B.P specs

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 1000ml



Sterifluid DS (FDL)


Approved

593. Medisol Hartmann’s (Compound Sodium Lactate) IV Infusion—B.P

Each 100ml contains.1. Sodium Chloride... 0.6g2. Potassium Chloride... 0.04g3. Calcium Chloride. 2H2O.. 0.027g4. Sodium Lactate (50% solution).. 0.64g5. Water for Injection

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 100ml


Compound Sodium Lactate solution for Infusion (Baxter Healthcare Ltd-UK)

Sterifluid –RL (FDL Limited)DML Inspection dated 16.03.16

Deferred for provision of approval status of formulation in same pack size by reference regulatories authorities and Pakistan and


Q.S..100ml

Electrolytes (B.P Specs)

clarification for use of sodium lactate in 50% solution form

594. Medisol Hartmann’s (Compound Sodium Lactate)IV Infusion—B.P

Each 100ml contains.1. Sodium Chloride... 0.6g2. Potassium Chloride... 0.04g3. Calcium Chloride. 2H2O.. 0.027g4. Sodium Lactate (50% solution).. 0.64g5. Water for Injection Q.S..100ml Electrolytes

(B.P Specs)

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 250ml



Sterifluid –RL (FDL Limited)


Deferred for provision of approval status of formulation in same pack size by reference regulatories authorities and Pakistan and clarification for use of sodium lactate in 50% solution form

595. Medisol Hartmann’s (Compound Sodium Lactate)IV Infusion—B.P

Each 100ml contains.1. Sodium Chloride... 0.6g2. Potassium Chloride... 0.04g3. Calcium Chloride. 2H2O.. 0.027g4. Sodium Lactate (50% solution).. 0.64g5. Water for Injection Q.S..100ml

Electrolytes (B.P Specs)

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 500ml







596. Medisol Hartmann’s (Compound Sodium Lactate)IV Infusion—B.PEach 100ml contains.

Each 100ml contains.1. Sodium Chloride... 0.6g2. Potassium Chloride... 0.04g3. Calcium Chloride. 2H2O.. 0.027g4. Sodium Lactate (50% solution).. 0.64g5. Water for Injection Q.S..100ml

Electrolytes

(B.P Specs)

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 1000ml






597. Medisol Paeds IV Infusion B.P

Each 100ml contains.1. Sodium Chloride...0.18g2. Dextrose Anhydrous...4.3g3. Water for Injection Q.S...100ml


B.P Specs

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 100ml


0.18% sodium chloride ,4% glucose B Braun Germany.

Sterifluid Paeds (FDL Limited)



598. Medisol Paeds IV Infusion B.PEach 100ml contains.1. Sodium Chloride...0.18g2. Dextrose Anhydrous...4.3g3. Water for Injection Q.S...100ml


B.P Specs

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 250ml










B.P Specs

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 500ml





Approved




B.P Specs

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 1000ml





Approved

601. Medisol ½ NS (Sodium Chloride 0.45%) Injection USP Each 100ml contains.Sodium Chloride............ 0.45gWater for Injection q.s ....100ml

Electrolytes

(USP Specs)

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 100ml


Sodium Chloride Injection 0.45% (Hospira USA)

Nisf Normal Saline(Otsuka Limited)



602. Medisol ½ NS (Sodium Chloride 0.45%) Injection USP

Each 100ml contains.Sodium Chloride............ 0.45g

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 250ml

Price =As per SRO


Nisf Normal

Deferred for provision of approval status of formulation in same


Water for Injection q.s ....100ml

Electrolytes

(USP Specs)

plus Eurocap price with single & double injection ports

Saline(Otsuka Limited)


pack size by reference regulatories authorities and Pakistan.


Each 100ml contains.Sodium Chloride............ 0.45gWater for Injection q.s ....100ml

Electrolytes

(USP Specs)

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 500ml





Approved


Each 100ml contains.Sodium Chloride............ 0.45gWater for Injection q.s ....100ml

Electrolytes

(USP Specs)

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 1000ml





Approved

605. Medilact-D Solution for Injection-USP

Each 100ml contains.1. Sodium Chloride... 0.6g2. Potassium Chloride ... 0.03g3. Calcium Chloride. 2H2O... 0.02g4. Sodium Lactate (50% solution)... 0.620g5. Dextrose Monohydrate... 5.0g6. Water for Injection Q.S...100ml

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 100ml


Lactated Ringer & Dextrose Injection Baxter Healthcare Corporation-USA

Sterifluid RLD (FDL Limited)


Deferred for provision of approval status of formulation in same pack size by reference regulatories authorities and Pakistan and clarificatio



USP Specs

n for use of sodium lactate in 50% solution form




USP Specs

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 250ml









USP Specs

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 500ml








Sodium Chloride 0Each 100ml contains.1. Sodium Chloride... 0.6g2. Potassium Chloride ... 0.03g3. Calcium Chloride. 2H2O... 0.02g4. Sodium Lactate (50% solution)... 0.620g5. Dextrose Monohydrate... 5.0g6. Water for Injection Q.S...100ml


USP Specs

FORM 5 Rs 20,000/-24.05.16 ,

Pack size 1000ml






Tablet (General)609. M/s Jupiter

PharmaPlot # 25, St# S6 RCCI Rawat Rawalpindi.

Tablet (General)Approved in 247th meeting of central licensing board held on 29-04-2016

Tablet Anatrin Each tablet contains Nitrofurantoin 100 mg (BP).

AntibacterialBP Specification

Form 5Rs. 20000/-(13-06-2016)Dy.No 2653

Pack of 10 x 10’s as per DPC

MHRA approved Aratoin – Dr. Reddy, UK

Furadin (Ferozsons)

Approved

610. -do- Tablet Jucip 250

Each film coated tablet containsCiprofloxacin (as HCl.2H2O) 250mg.

Antibiotics(USP Specification)

Form 5Rs. 20000/-(13-06-2016)Dy.No 2652

Pack of 1x 10’s as per DPC

MHRA approved brand of Dr. Reddy, UK

Novidat - Sami

Approved


611. -do- Tablet Jucip 500

Each film coated tablet contains Ciprofloxacin (as HCl.2H2O) 500mg

Antibiotics(USP Specification)

Form 5Rs. 20000/-(13-06-2016)Dy.No 2650


MHRA approved brand of Dr. Reddy, UK

Novidat - Sami

Approved

612. -do- Tablet Julin 250

Each film coated tablet contains Levofloxacin (as hemihydrate ) 250mg

Quinolones(Jupiter’s Specs)

Form 5Rs. 20000/-(13-06-2016)Dy.No 2649


MHRA approved Evoxil – Beacon

Leflox-Getz

Approved

613. -do- Tablet Julin -500

Each film coated tablet containsLevofloxacin (as hemihydrate) 500mg

Quinolones(Jupiter’s Specs)

Form 5Rs. 20000/-(13-06-2016)Dy.No 2651


MHRA approved Evoxil – Beacon

Leflox-Getz

Approved

614. -do- Tablet Jukast 5

Each chewable tablet containsMontelukast (as sodium) 5mg

Anti-asthmatic(Jupiter’s Specs)

Form 5Rs. 20000/-(13-06-2016)Dy.No 2647


MHRA approved brand of Aurobindo

Montika-Sami

Approved

615. -do- Tablet Jukast -10

Each film coated tablet contains Montelukast (as sodium) 10mg

(Jupiter’s Specs)Anti-asthmatic

Form 5Rs. 20000/-(13-06-2016)Dy.No 2648


MHRA approved Singulair – Merck

Singulair - OBS

Approved

616. -do- Tablet Mozter 400mg Form 5 MHRA Approved


Each film coated tablet containsMoxifloxacin HCl USP eq. to Moxifloxacin 400 mg

quinolone antibiotic(Manufacture Specs)

Rs. 20000/-(13-06-2016)Dy.No 2642


approved Avelox

Moxiget -Getz

617. -do- Tablet Resjun-1

Each film coated tablet contains Risperidone 1mg

Benzisoxazole derivatives (USP Specs)

Form 5Rs. 20000/-(13-06-2016)Dy.No 2643


MHRA approved Risperdal –Janssen

Benzisox -Highnoon

Approved

618. -do- Tablet Resjun -2

Each film coated tablet contains Riperidone 2mg Benzisoxazole derivatives (USP Specs)

Form 5Rs. 20000/-(13-06-2016)Dy.No 2646



Benzisox -Highnoon

Approved

619. -do- Tablet Resjun -3

Each film coated tablet contains Riperidone 3mg


Form 5Rs. 20000/-(13-06-2016)Dy.No 2645



Benzisox -Highnoon

Approved

620. -do- Tablet Resjun-4

Each film coated tablet contains Riperidone 4mg


Form 5Rs. 20000/-(13-06-2016)Dy.No 2644



Benzisox -Highnoon

Approved


621. -do- Tablet Pirujin

Each tablet Contains Piroxicam B cyclodextrin 191.2mg eq to Piroxicam 20mg

Analgesics, antipyretics(Jupiter’s specs)

Form 5Rs. 20000/-(13-06-2016)Dy.No 2665


Tablet Brexine 20mg –Chiesi – France

Brexin -Chiesi

Approved

622. -do- Tablet Marlin

Each tablet contains Artemether ..20mg Lumefentrine 120mg (Jupiter’s specs) Antimalarial

Form 5Rs. 20000/-(13-06-2016)Dy.No 2636



Artem -Hilton

Approved

623. -do- Tablet Marlin Fort

Each tablet contains Artemether ..40mg Lumefentrine 240mg

(Jupiter’s specs) Antimalarial

Form 5Rs. 20000/-(13-06-2016)Dy.No 2635



Artem -Hilton

Approved

624. -do- Tablet Marlin DS

Each tablet contains Artemether ..80mg Lumefentrine 480mg

(Jupiter’s specs) Antimalarial

Form 5Rs. 20000/-(13-06-2016)Dy.No 2662



Artem -Hilton

Approved

625. -do- Tablet J-Rox CR 12.5

Each enteric film coated controlled released tablet contains Paroxetin as HCl 12.5mg

(Jupiter’s specs)SSRIs

Form 5Rs. 20000/-(13-06-2016)Dy.No 2654


USFDAPaxil SR-GSK

Seroxat CR-GSK

Approved


626. -do- Tablet J-Rox CR 25

Each enteric film coated controlled released tablet contains Paroxetin as HCl 25mg

(Jupiter’s specs)SSRI

Form 5Rs. 20000/-(13-06-2016)Dy.No 2663


USFDAPaxil SR-GSK

Seroxat CR-GSK

Approved

627. -do- Tablet Amlodine 5/80 Each film coated tablet contains Amlodipine (as besylate) 5mg Valsartan 80mg

(Jupiter’s specs)Calcium channel blocker.Angiotensis II (AT1) receptor antagonist

Form 5Rs. 20000/-(13-06-2016)Dy.No 2659

Pack of 14’s as per DPC

MHRA approved Exforge- Novartis

Exforge – Novartis

Approved

628. -do- Tablet Amlodine 5/160

Each film coated tablet contains Amlodipine (as besylate) 5mg Valsartan 160mg

(Jupiter’s specs)Calcium channel blocker.Angiotensis II (AT1) receptor antagonist.

Form 5Rs. 20000/-(13-06-2016)Dy.No 2660




Approved

629. -do- Tablet Amlodine 10/160

Each film coated tablet contains Amlodipine (as besylate) 10mg Valsartan 160mg

(Jupiter’s specs)Calcium channel blocker.Angiotensis II (AT1) receptor antagonist.

Form 5Rs. 20000/-(13-06-2016)Dy.No 2657




Approved


630. -do- Tablet Judol

Each tablet contains Alfacalcidol 0.5mcg

(Jupiter’s specs)Vitamin –D Analogue

Form 5Rs. 20000/-(13-06-2016)Dy.No 2650


Adela - getz Deferred as 10 molecules per section has already been approved

631. -do- Mides

Each film coated tablet contains Desloratadine 5mg

( Jupiter’s specs).Antihistamine

Form 5Rs. 20000/-(13-06-2016)Dy.No 2655



Alenor – Macter

Deferred as 10 molecules per section has already been approved

632. -do- Tablet Jubal

Each sugar coated tablet containsMecobalamin 500 mcg

Vitamin B-12 Manufacture Specification

Form 5Rs. 20000/-(13-06-2016)Dy.No 2658



Anemovit - Pharmacare

Deferred as 10 molecules per section has already been approved

Capsule (General)633. M/s Jupiter


Capsule (General)Approved in 247th meeting of central licensing board held on

Capsule Jutrazole

Each capsule contains Fluconazole 150mg

Synthetic azole/Systemic antifungal agent(Jupiter’s Specs)

Form 5Rs. 20000/-(13-06-2016)Dy.No 2641


MHRA approved Azocan-P, FDC

Axicon - Axis

Approved


29-04-2016634. -do- Capsule J-Baline-50

Each capsule contains Pregabalin 50mg

(Jupiter’s specs)anti-epileptic drug, also called an anticonvulsant agent.

Form 5Rs. 20000/-(13-06-2016)Dy.No 2621


US FDALYRICACapsules (25, 50, 75, 100, 150,200, 225 and 300mg)

ZEEGAPCapsules (25, 50, 75, 100 and 150mg)Hilton

Approved

635. -do- Capsule J-Baline -75

Each capsule contains Pregabaline 75mg


Form 5Rs. 20000/-(13-06-2016)Dy.No 2622




Approved

636. -do- Capsule J-Baline-100

Each capsule contains Pregabaline 100mg


Form 5Rs. 20000/-(13-06-2016)Dy.No 2629




Approved

637. -do- Capsule Tamsel 400mcg

Each capsule contains Tamsulosin HCl (as modified released pellets 0.2 %) eq to Tamsulosine 0.4mg

(Jupiter’s Specs)α1-Adrenergic blocking agent with selectivity for

Form 5Rs. 20000+30000= 50000(13-06-2016)(17-06-2016)Dy.No 2630


MHRA approved Tabphyn-Genus

Alfamax -Platinum

Approved


α1A-adrenergic receptors

Source of pellets:-M/s Vision Pharmaceuticals, Kahuta road, Islamabad.

638. -do- Capsule Azoter

Each capsule contains Azithromycin (as dehydrate) 250mg

(USP Specs)Macrolide Antibiotic agent.

Form 5Rs. 20000/-(13-06-2016)Dy.No 2631


MHRA approved Zithromax –Pfizer

Azelide-Hygeia

Approved

639. -do- Capsule Mebal

Each capsule contains Mecobalamine 500mcg

(Jupiter’s specs)Antianemic agent

Form 5Rs. 20000/-(13-06-2016)Dy.No 2637


Innovit -Werrick

Proof of approval status of same dosage form in reference countries not given.

Deferred for approval status of same dosage form in reference countries.

640. -do- Capsule Jucam

Each capsule containsPiroxicam 20mg

(USP Specs)NSAID

Form 5Rs. 20000/-(13-06-2016)Dy.No 2633


MHRA approved feldene-Pfizer

Feldene -Pfizer

Approved

641. -do- Capsule Judep Plus

Each capsule contains Fluoxetine (as HCl) 25 mg Olanzopine 6mg

(USP specs)Antidepressent

Form 5Rs. 20000/-(13-06-2016)Dy.No 2623


USFDA SYMBAX

Co-Depricap, NabiQasim

Approved

642. -do- Capsule Lansjup 30mg

Each capsule contains Lansoprazole (as enteric

Form 5Rs. 50000/-(13-06-2016)Dy.No 2624


Approved


coated pellets 8.5% ) eq to Lansoprazole 30mg

(USP Specs)Proton Pump Inhibitor

Source of pellets:-M/s Vision Pharmaceuticals, Kahuta Road, Islamabad.


Doudcer-nil - Global

643. -do- Capsulr Esojup-20

Each capsule contains Esomeprazol(as Megnesium trihydrate enteric coated pellet 22.5% ) eq to Esomeprazole 20mg

(Jupiter’s Specs)Proton Pump Inhibitor


Form 5Rs. 50000/-(13-06-2016)Dy.No 2628

Pack of 14’s per DPC

MHRA approved Emozul-Consilient

ESSO-Shaigan

Approved

644. -do- Capsule Esojup- 40

Each capsule contains Esomeprazole (as Megnesium trihydrate enteric coated pellet 22.5% ) eq to Esomeprazole 40mg

(Jupiter’s Specs)Proton Pump Inhibitor

Form 5Rs. 50000/-(13-06-2016)Dy.No 2625


MHRA approved Emozul-Consilient

ESSO-Shaigan


Approved

645. -do- Capsule Jumep -20

Each capsule contains omeprazol(enteric coated pellet 8.5 ) eq to omeprazole 20mg

(USP Specs)

Form 5Rs. 50000/-(13-06-2016)Dy.No 2627


MHRA approved Losec – AstraZeneca

Risek-Getz

Approved


Proton Pump Inhibitor


646. -do- Capsule Jumep- 40

Each capsule contains omeprazole (enteric coated pellet 8.5) eq to omeprazole 40mg

(USP Specs)Proton Pump Inhibitor


Form 5Rs. 50000/-(13-06-2016)Dy.No 2626

Pack of 14’s per DPC

MHRA approved Losec – AstraZeneca

Risek-Getz

Approved

Oral Dry Powder Suspension647. M/s Jupiter


Dry Powder Suspension (General)Approved in 247th meeting of central licensing board held on 29-04-2016

Azoter Dry Powder for Suspension

Each 5ml of reconstituted suspension contains Azithromycin (as dehydrate) 200mg

( USP Specs)Macrolide Antibiotic agent.

Form 5Rs. 20000/-(13-06-2016)Dy.No 2634

Pack of 15ml as per DPC


Azomax -Novartis

Approved

648. -do- Marlin Suspension 15/90

Each 5ml of

Form 5Rs. 20000/-(13-06-2016)Dy.No 2661


Approved


reconstituted suspension contains Artemether 15mg Lumefentrine 90mg

(jupiter’s specs)Anti malarial


Artem - Hilton

649. -do- Marlin DS Suspension 30/180

Each 5ml of reconstituted suspension contains Artemether 30mg Lumefentrine 180mg

(jupiter’s specs)Anti malarial

Form 5Rs. 20000/-(13-06-2016)Dy.No



Artem - Hilton

Approved

650. -do- Clariter Oral Drops

Each 5ml of reconstituted suspension containsClarithromycin 125mg Granules for suspension

Macrolide Antibiotic agent.(USP Specs)

Form 5Rs. 20000/-(13-06-2016)Dy.No 2637



Klaricid – Abbott

Approved

651. -do- J-Linz Suspension

Each 5ml reconstituted suspension containsLinezolid 100 mg Powder for suspension

(Jupiter’s Specs) synthetic antibiotic, the first of the oxazolidinone class

Form 5Rs. 20000/-(13-06-2016)Dy.No 2638


USFDA Zyvox –Pharmacia upjouhn

Nezocin - brookes

Approved

652. -do- Jutrazole Dry Suspension

Each 5ml reconstituted suspension containsFluconazole 50 mg

(USP Specs) Synthetic azole/Systemic

Form 5Rs. 20000/-(13-06-2016)Dy.No 2639


MHRA Diflucan –Pfizer

Diflucan -Pfizer

Approved


antifungal agent.

653. -do- Zincter Suspension

Each 5ml reconstituted suspension containsZinc sulphate monohydrate eq to Elemental Zinc 20 mg

(Jupiter’s Specs) Zinc supplement

Form 5Rs. 20000/-(13-06-2016)Dy.No 2640



Zincat

Product under review as waiting for reply from WHO.

Deferred as Product is under review and sent for comments of WHO.

Evaluator-IV Salateen Waseem PhilpNew License of M/s Regal Pharmaceuticals, Plot # 2-A, Street # S-5 National industrial zone Rawat-Islamabad





Remarks Decision

Tablet (General)654. M/s Regal

Pharmaceuticals, Plot # 2-A, Street # S-5 National industrial zone Rawat-Islamabad

DML of firm approved in 247st

meeting of Central Licensing Board held on 29-04-2016.

Regcam Tablet 4 mg

Each film coated tablet contains: Lornoxicam 4 mg

(Regal Spec) NSAID.

Form 5Rs. 20,000/-08-06-2016Dy. No. 2460

Pack of 10’s/as per DPC20’s / as per DPC30’s / as per DPC

EMA approved Brand Xefo

Loricam - Saffron

Approved

655. -do- Regcam Tablet 8 mg

Each film coated tablet contains: Lornoxicam 8 mg

(Regal Spec) NSAID.

Form 5Rs. 20,000/-08-06-2016Dy. No. 2462

Pack of 10’s/as per DPC

EMA approved Brand Xefo

Loricam - Saffron

Approved


20’s / as per DPC30’s / as per DPC

656. -do- Regoxin CR Tablet 12.5 mg

Each enteric coated controlled release tablet contains:Paroxetine Hcl eq to Paroxetine 12.5mg

(USP Spec)SSRI

Form 5Rs. 20,000/-08-06-2016Dy. No. 2457


FDA approved Paxil CR - GSK

Tablet Deroxat 12.5 mg by Gobal pharma

Approved

657. -do- Regoxin CR Tablet 25 mg Each enteric coated controlled release tablet contains:Paroxetine Hcl eq to Paroxetine 25mg

(USP Spec)SSRI

Form 5Rs. 20,000/-08-06-2016Dy. No. 2461


FDA approved Paxil CR- GSK

Tablet Deroxat 12.5 mg by Gobal pharma

Approved

658. -do- Dinac Tablet 50 mg

Each Delayed release tablet contains:Diclofenac sodium 50mg + Misoprostol 200mcg

(Regal Spec)Pain reliever

Form 5Rs. 20,000/-08-06-2016Dy. No. 2458

Pack of 10’s/as per DPC20’s / as per DPC

FDA approved Arthrotec – health care UK.

Erwin –Sami

Proof of Double punch compression machine.


Firm needs to follow innovator brand formulation.

Complete manufacturing method including procedure of outer core of misoprostol, on diclofenac sodium tablet before enteric coating.

Deferred for Confirmation

by FID for double punch compression machine.





659. -do- Dinec Tablet 75 mg

Each delayed release tablet contains:Diclofenac sodium 50mg Misoprostol 200mcg

(Regal Spec)Pain reliever

Form 5Rs. 20,000/- 08-06-2016)Dy. No. 2455


FDA approved Arthrotec – health care UK.

Erwin –Sami

Proof of Double punch compression machine.




Deferred for Confirmation

by FID for Double punch compression machine.




660. -do- Pesom Tablet 50 mg

Each sugar coated tablet contains:Eperisone Hcl 50mg

(Regal Spec)Anticholinergic

Form 5Rs. 20,000/-08-06-2016)Dy. No. 2449


Myonal – Eisai

Qulax – Myonal

Approved

661. -do- Epiwell CR Tablet 250

Each Controlled release tablet contains:Divalproex sodium 250mg

(USP Spec)Antiepileptic

Form 5Rs. 20,000/-08-06-2016Dy. No. 2473


USFDA Depakote

LocalTablet Leptil at 250 mg by Donvalley pharmaceuticals

Deferred as more than 10 molecules

662. Regal Pharmaceuticals, Plot # 2-A, Street

Epiwell CR Tablet 500

Form 5Rs. 20,000/-08-06-2016

USFDA Depakote

Local



# S-5 National industrial zone Rawat-Islamabad



Each Controlled release tablet contains:Divalproex sodium 500mg

(USP Spec)Antiepileptic

Dy. No. 2465


Tablet Leptil at 250 mg by Donvalley pharmaceuticals

663. -do- Radol-P Tablet 325/37.5 mg Each Film coated tablet contains:Paracetamol 325mg Tramadol 37.5mg(Regal Spec)Opiod analgesic

Form 5Rs. 20,000/-08-06-2016Dy. No. 2453


MHRATablet Tramacet 325/37.5mg manufactured by Grunenthal

LocalTablet Tronoflex P 325/37.5 mg by Sami pharma

Approved

664. -do- Zolid Tablet 600 mg

Each Film coated tablet contains:Linezolid 600mg

(Regal Spec)Oxazolidone Antibiotic

Form 5Rs. 20,000/-08-06-2016Dy. No. 2450


MHRATablet Zyvox 600mg manufactured by 338fizer

LocalTablet Nezolide 600 mg by Searl pharma

Approved

665. -do- Solfine Tablet 5 mg

Each Film coated tablet contains:Solifenacin succinate 5mg

(Regal Spec)Antimuscarinic

Form 5Rs. 20,000/-08-06-2016Dy. No. 2459


MHRAVesicare –Astellas UK

Fenaso – Highnoon

Approved

666. -do- Solfine Tablet 10 mg Each Film coated tablet contains:Solofinacin succinate 5mg

(Regal Spec)

Form 5Rs. 20,000/-08-06-2016Dy. No. 2469


MHRAVesicare Astellas

Tablet Vezitic 5mg By CCL

Approved


Antimuscarinic667. Regal




Qupixan Tablet 25 mg

Each Film coated tablet contains:Quetapine 25mg as Quetapine Fumarate

(USP Spec)Dibenzothiazepine

Form 5Rs. 20,000/-08-06-2016Dy. No. 2457


MHRAQuetapine – Sandoze UK

Q-Par – Helix

Approved

668. -do- Qupixan Tablet 50 mg



Form 5Rs. 20,000/-08-06-2016)Dy. No. 2472



Q-Par – Helix

Approved

669. -do- Qupixan Tablet 100 mg



Form 5Rs. 20,000/-08-06-2016Dy. No. 2467



Q-Par – Helix

Approved

670. -do- Brudex Tablet 400 mg Each Film coated tablet contains:Dexibuprofen 400mg

(Manufacture Spec)Propionic acid

Form 5Rs. 20,000/-08-06-2016Dy. No. 2470


Seractil (Genus Pharmaceuticals UK) BNF-67

Dexib –Tabros


671. Regal Pharmaceuticals, Plot # 2-A, Street # S-5 National industrial zone Rawat-Islamabad

Re-SPA Tablet 80 mg

Each Film coated tablet contains:Drotaverine 80mg as Drotaverine Hcl

Form 5Rs. 20,000/-08-06-2016Dy. No. 2468


NO-SPA FORTE

Himont





(Regal Spec)

Anti-Spasmodic

50’s / as per DPC

672. -do- Repram Tablet 10 mg

Each Film coated tablet contains:Escitalopram 10mg as Escitalopram Oxalate

(USP Spec)Anti depressant

Form 5Rs. 20,000/- 08-06-2016Dy. No. 2466


MHRACipralex Lundback

Product of NabiQasim pharma

Approved

673. Repram Tablet 20 mg

Each Film coated tablet contains:Escitalopram 20mg as Escitalopram Oxalate

(USP Spec)

Anti depressant

Form 5Rs. 20,000/-08-06-2016Dy. No. 2451


MHRACipralex Lundback

Product of NabiQasim pharma

Approved

674. -do- O-Mox Tablet 400 mg

Each Film coated tablet contains:Moxifloxacin 400mg as Moxifloxacin Hcl

(Regal Spec)FlouroQuinolone Antibiotic

Form 5Rs. 20,000/-08-06-2016)Dy. No. 2463


MHRA Avelox Bayer

Moxiget – Getz


675. M/s Regal Pharmaceuticals, Plot # 2-A, Street # S-5 National industrial zone Rawat-Islamabad

DML of firm approved in 247th

meeting of Central

Mograll Fort Tablet

Each Film coated tablet contains:Orphenadrine Citrate 50mg + Paracetamol 450mg+ Caffeine 30mg

(Regal Spec)

Analgesic / Central

Form 5Rs. 20,000/-08-06-2016Dy. No. 2471

Pack of 30’s/as per DPC50’s/as per DPC

100’s/as per DPC

Approved status in Pakistan reference countries not approved

LocalTablet Medigesic Fort ByWilshire pharma



Licensing Board held on 29-04-2016.

anti cholinergic / Xanthine

676. -do- Rostin Tablet 5mg

Each Film coated tablet contains:Rosuvastatin 5mg as Rosuvastatin Calcium

(Regal Spec)Lipid regulating agent

Form 5Rs. 20,000/- 08-06-2016Dy. No. 2456


MHRACrestor 5mgAstrazeneca UK

LocalTablet Loster ByHelix pharma

Approved

677. Rostin Tablet 10mg

Each Film coated tablet contains:Rosuvastatin 10mg as Rosuvastatin Calcium

(Regal Spec)Lipid regulating agent

Form 5Rs. 20,000/-08-06-2016Dy. No. 2454


20’s/as per DPC

MHRACrestor Astrazeneca UK

LocalTablet Loster ByHelix pharma

Approved

CAPSULE (GENERAL)678. Regal




Resold Capsule 20mg

Each Capsule contains:Enteric coated pallets of Esomeprazole 20mg as Esomeprazole magnesium 341olymalto

(USP Spec)Proton Pump Inhibitor

Source of Esomeprazole Mg ECP pellets 22.5%:-M/s Vision Pharmaceuticals, Plot # 22-23, Industrial Triangle, Kahuta Road, Islamabad.

Form 5Rs. 50,000/-08-06-2016Dy. No. 2493


MHRA approved Emozul

Esso – Shaigan

Approved

679. M/s Regal Pharmaceuticals, Plot # 2-A, Street # S-5 National

Resold Capsule 40mg

Each Capsule

Form 5Rs. 50,000/-08-06-2016Dy. No. 2496

MHRAEmozul

Esso – Shaigan

Approved


industrial zone Rawat-Islamabad



contains:Enteric coated pallets of Esomeprazole 40mg as Esomeprazole magnesium dehydrate

(USP Spec)Protin pump Inhibitor

Source of Esomeprazole Mg ECP pellets 22.5%:-M/s Vision Pharmaceuticals, Plot # 22-23, Industrial Triangle, Kahuta Road, Islamabad.


680. Thicosid 4mg Capsule

Each Capsule contains:Thiocolchicoside 4mg

(Regal Spec)Skeletal muscle relaxant

Form 5Rs. 20,000/-08-06-2016Dy. No. 2491

Pack of 20’s / as per DPC14’s/as per DPC


Muscoril –Searle

Approved

681. Regastat 120mg Capsule

Each Capsule contains immediate release pallets of Olrlistat 120mg

(USP Spec)Lipase inhibitor

Source of Orlistat IR pellets 50%:-M/s Vision Pharmaceuticals, Plot # 22-23, Industrial Triangle, Kahuta Road, Islamabad.

Form 5Rs. 50,000/-08-06-2016)Dy. No. 2513

Pack of 20’s / as per DPC

FDA approved Xenical

Alli 120mgGSK consumer health care USA

LocalCapsule Febical ByHighnoon Laboratories

Approved

682. -do- Regalin 50mg Capsule

Each Capsule contains:Pregabalin 50mg

Form 5Rs. 20,000/-08-06-2016Dy. No. 2506

Pack of 14’s /

FDA approvedLyrica Pfizer

Gabalin - CCL

Approved


(Regal Spec)GABA Analogue

as per DPC




Form 5Rs. 20,000/-08-06-2016)Dy. No. 2498



Gabalin - CCL

Approved




Form 5Rs. 20,000/-08-06-2016Dy. No. 2489



Gabalin - CCL

Approved

685. -do- Olanzin – F 3/25mg Capsule

Each Capsule contains:Olanzapine 3mg Fluoxetine 25mg

(USP Spec)Thienobenzodiazepine /SSRI

Form 5Rs. 20,000/-08-06-2016)Dy. No. 2497


USFDA SYMBAX


Approved

686. -do- Capsule Olanzin – F 6/25



Form 5Rs. 20,000/-08-06-2016Dy. No. 2514


USFDA SYMBAX


Approved

687. Olanzin – F 12/25mg Capsule


Form 5Rs. 20,000/-08-06-2016Dy. No. 2488


USFDA SYMBAX


Me too needs confirmation

Approved






Recoxib 200mg Capsule

Each Capsule contains:Celecoxib 200mg

(Regal Spec)COX -2 Inhibitor

Form 5Rs. 20,000/-08-06-2016Dy. No. 2502

Pack of 10’s / as per DPC20’s / as per DPC30’s / as per DPC

MHRA approved Celebrex – Pfizer

Artiflex – Standpharm

Approved


Tamsuger 0.4mg Capsule

Each Capsule contains:Tamsulosin HCl SR pellets 0.2% eq to Tamsulosin 0.4mg

(USP Spec)Slective alpha-1 blocker

Source of pellets :-M/s Vision Pharmaceutcals , Kahuta rOad, Islamabad.

Form 5Rs. 50,000/-08-06-2016Dy. No. 2494


FDA approvedContiflo XLE.Lilly and company

LocalCapsule ProsetBySynchro pharma

Approved

690. -do- Venflax XR 37.5mg CapsuleEach Capsule contains:Extended release pallets of Vanlafaxine 37.5mg as Vanlafaxine Hcl

(USP Spec)

Serotonin & noradrenaline reuptake inhibitor

Source of Venlafaxine HCl SR pellets 33% :-

Form 5Rs. 50,000/-08-06-2016Dy. No. 2595


14’s / as per DPC

Proof of approval status of same dosage form in reference countires and Pkaistan not provided.

Deferred for confirmation of approval status of formulation by reference regulatory authorities and Pakistan.


M/s Vision Pharmaceuticals, Plot # 22-23, Industrial Triangle, Kahuta Road, Islamabad.

691. -do- Venflax XR 75mg Capsule

Each Capsule contains:Extended release pallets of Vanlafaxine 75mg as Vanlafaxine Hcl

(USP Spec)Serotonin & noradrenaline reuptake inhibitor

Source of Venlafaxine HCl SR pellets 33% :-M/s Vision Pharmaceuticals, Plot # 22-23, Industrial Triangle, Kahuta Road, Islamabad.

Form 5Rs. 50,000/-08-06-2016)Dy. No. 2492


14’s / as per DPC

FDA approvedEfexor XLPfizer LtdUSA

Venalax – Stand pharm

Approved


Erox 60mg Capsule

Each Capsule contains:Etroricoxib 60mg

(Regal Spec)Cyclooxygenase inhibitor

Form 5Rs. 20,000/- 08-06-2016Dy. No. 2499


20’s / as per DPC

The proposed formulation is in tablet form in reference countries and not in capsule form.

Rejected as proposed formulation is approved in tablet dosage form by reference regulatory authorities

693. -do- Rethro 250mg Capsule

Each Capsule contains:Azithoromycin 250mg asAzithromycin dehydrate

(USP Spec) Macrolide antibiotic

Form 5Rs. 20,000/-08-06-2016Dy. No. 2487


10’s / as per DPC

FDA approvedAzisara 250mgPiramal healthcare

LocalCapsule Bactizith 250mgByWoodwards

Approved

694. -do- Mervin- MR 200mg Capsule

Form 5Rs. 50,000/-

MHRAClofac MR

Innovator brand contains

Deferred for confirmation


Each Capsule contains:Mebeverine HCl SR pellets 50% eq to Mebeverine Hcl 200mg

(Regal Spec)AntispasmodicSource of pellets:-M/s Vision Pharmaceuticals, Kahuta Road, Ilsambad.

(21-06-2016)Dy. No. 2464

Pack of 10’s / as per DPC20’s / as per DPC30’s / as per DPC

BGP LtdUK

LocalCapsule Mebeverine MRByGetz pharma

modified release granules.

whether granules of M/s Vision Pharma are modified release or otherwise

ORAL DRY POWDER (GENERAL)


Rethrocin 125mg /5ml oral drops

Each 5ml of reconstituted suspension contains:Clarithromycin 27.5% EC Taste Masked pellets eq to Clarithromycin 125mg

(USP Spec) Macrolide antibiotic

Source of pellets :-M/s Vision Pharmaceuticals, Kahuta rOad, Islamabad.

Form 5Rs. 20,000/-08-06-2016)Dy. No. 2528

Pack of 60ml / as per DPC

FDA approvedClaricid 125mg/5mlAbbott laboratories

LocalClaritek 125mg/5mlByGetz pharma

The innovator brand is in granules formulation.

Approved



meeting of Central Licensing Board held on 29-04-

Rethrocin 250mg /5ml oral suspension

Each 5ml of reconstituted suspension contains:Clarithromycin 27.5% EC Taste Masked pellets eq to Clarithromycin 250mg

(USP Spec)

Form 5Rs. 20,000/-08-06-2016Dy. No. 2530


FDA approvedClaricid 250mg/5mlAbbott laboratories

LocalClaritek 250mg/5mlByGetz pharma

The innovator brand is in granules formulation.

Approved


2016. Macrolide antibiotic

Source of pellets :-M/s Vision Pharmaceuticals, Kahuta rOad, Islamabad.

697. -do- Azocine 200mg /5ml oral Dry Suspension

Each 5ml (reconstituted) contains:Azithromycin 200mg

(USP Spec)

Macrolide antibiotic

Form 5Rs. 20,000/-08-06-2016)Dy. No. 2524


15ml / as per DPC

MHRA approved brand of 347andoz

LocalZithrosan 200mg/5mlBySante pharma

Approved

698. -do- Remal 15/90mg /5ml oral Dry suspension

Each 5ml (reconstituted) contains:Artimether 15mg Lumefantrine 90mg.

(Manufacture Spec)Anti-malarial

Form 5Rs. 20,000/-08-06-2016)Dy. No. 2525


60ml / as per DPC


Artem – Hilton

Approved

699. -do- Remal 20/120mg /5ml oral D/S

Each 5ml (reconstituted) contains:Artimether 20mg Lumefantrine 120mg.

(Manufacture Spec)

Anti-malarial

Form 5Rs. 20,000/-08-06-2016)Dy. No. 2531


60ml / as per DPC

LocalArceva 20/120mg/5mlBySami pharmaceuticals

Proof provided by firm for proposed formulation availability in reference countires and Pakistan is not correct.

Rejected as proposed formulation is neither approved by reference regulatory authorities nor recommended by WHO.


Zolid 100mg /5ml oral D/S

Each 5ml (reconstituted) contains:Linzolide 100mg Powder for

Form 5Rs. 20,000/-08-06-2016Dy. No. 2490


FDA approved100mg/5ml

LocalNezilide 100mg/5mlBySearle





suspension

(Regal Spec)Antibiotic

pharmaceuticals

701. -do- Zincal 10mg /5ml oral D/S

Each 5ml contains:Zinc Sulphate 10mg.

(Regal Spec)Zinc Supplement

Form 5Rs. 20,000/-08-06-2016)Dy. No. 2527


LocalRite-Zinc 10mg/5mlByFynk pharmaceuticals

The proposed formulation in dry powder forms while WHO recommended formulation is oral solution.

Deferred for confirmation of approval status by reference regulatory authorities or WHO in dry powder suspension.

702. R – Flucon 50mg /5ml oral D/S

Each 5ml contains:Fluconazole 50mg

(Regal Spec)

Anti-Fungal

Form 5Rs. 20,000/-08-06-2016)Dy. No. 2526


MHRADiFlucan one 50mg/5mlJhonson & JhonsonNewsland

LocalZolanix ByGSK pharmaceuticals


703. -do- Re – Dos 175mg /5ml oral Dry suspension

Each 5ml of reconstituted suspension contains:Erdosterine 175mg

(Regal Spec)Mucolytic agent

Form 5Rs. 20,000/-08-06-2016)Dy. No. 2785


LocalDostin ByBrooks pharmaceuticals

The product is not available in the proposed formulation in reference countires.




meeting of Central Licensing Board held on 29-04-

Resar 100mcg /5ml oral D/S

Each 5ml contains:Formoterol fumarate 100mcg

(Regal Spec)

Mucolytic

Form 5Rs. 20,000/-08-06-2016Dy. No. 2787


MHRAForadil Novartis Uk LtdUK

LocalEasair ByPlatinumpharmaceuticals

Firm doesn’t possess segregated licensed manufacturing facility for Capsule (Steroid)

Deferred for confirmation of approval status of formulation by reference regulatory authorities and Pakistan in dry powder suspension. Moreover status of product will also be verified as steroid or otherwise


2016.705. -do- Re-Zox 100mg /5ml

oral D/S

Each 5ml contains:Nitazoxanide 100mg

(Regal Spec)

Nitrothiazolyl-salicylamide prodrug

Form 5Rs. 20,000/-08-06-2016Dy. No. 2786


FDA approvedAlinia Lupin pharma USA

LocalIzato BySamipharmaceuticals

Approved

706. -do- Regsan500mg /30ml oral D/S

Each dose of 30ml contains:Secnidazole 500mg

(Regal Spec)

Nitoimidazole

Form 5Rs. 20,000/-08-06-2016Dy. No. 2783


Liviat –SizaReference countries approval status required


707. -do- Regsan 750mg /30ml oral Dry suspension

Each dose of 30ml contains:Secnidazole 750mg

(Regal Spec)Nitoimidazole

Form 5Rs. 20,000/-08-06-2016Dy. No. 2784


Eknit – Hilton Reference countries approval status required.


ORAL LIQUID SYRUP/SUSPENSION (GENERAL)708. Regal




Metrozole Plus Oral suspension

Each 5ml contains:Metronidazole as Benzoate 200mgDiloxanide furoate 250mg

(Regal Spec)Nitoimidazole , Amoebicide

Form 5Rs. 20,000/-08-06-2016)Dy. No. 2518


Metrodil –SharexThe product not dound in reference countires.


709. -do- Metrozole Oral Liquid suspension

Each 5ml contains:Metronidazole (as Benzoate) 200mg

Form 5Rs. 20,000/-08-06-2016Dy. No. 2522

Pack of

MHRAFlygl, Sanofi- Aventis UK

Flgyl Sanofi-

Approved


(BP Spec)Nitoimidazole

60ml /as per DPC120ml /as per DPC450ml / as per DPC

Aventis

710. -do- Dom – V Oral Liquid suspension

Each 5ml contains:Domperidone Maleate 5mg

(Regal Spec)Anti-dopaminergic

Form 5Rs. 20,000/-08-06-2016)Dy. No. 2517

Pack of 60ml / as per DPC120ml / as per DPC

MHRA-UKApproved product

Motillium – J & J

Approved

711. -do- Sucralate Oral Liquid suspension

Each 5ml contains:Sucralfate 1gm

(Regal Spec)Anti-ulcerant/ mucoprotactant

Form 5Rs. 20,000/-08-06-2016)Dy. No. 2519

Pack of60ml / as per DPC120ml /as per DPC

MHRAAntepsin 1gm Merk Barcelona spain

Ulsonic – Highnoon

Approved




Brofenac Oral liquid suspension

Each 5ml contains:Ibuprofen 100mg

(USP Spec)Analgesic /Antipyretic

Form 5Rs. 20,000/-08-06-2016)Dy. No. 2521


MHRA approved brand UK

Brufen – Abbott

Approved

713. -do- Brofenac DSOral liquid suspensionEach 5ml contains:Ibuprofen 200mg

(USP Spec)Analgesic /Antipyretic

Form 5Rs. 20,000/-08-06-2016Dy. No. 2529


MHRA approved brand UK

Brufen – Abbott

Approved

714. -do- Levocine oral solution

Each 5ml contains:

Form 5Rs. 20,000/-08-06-2016Dy. No. 2477

FDA approvedXyzal oral solutionUCB pharmaUSA

Approved


Levocetirizine as di-hydro chloride 2.5mg

(Regal Spec)

Anti-Histamine


LocalOcitra BySearle laboratories

715. -do- Epiwell 250mgOral Liquid syrup’

Each 5ml contains:Sodium valproate 250mg

(USP Spec)

Anti-Epileptic

Form 5Rs. 20,000/-08-06-2016)

Dy. No. 2516


Reference countires and Pakistan approval status not given.


716. -do- Epiwell 500mgOral Liquid syrup

Each 5ml contains:Divalproex 500mg(USP Spec)Anti-Epileptic

Form 5Rs. 20,000/-08-06-2016Dy. No. 2512


Reference countires and Pakistan approval status not given.


717. -do- Regadryl Oral Liquid syrup

Each 5ml contains:Amiophylline 32mg Diphanhydramin 8mg.Ammonium chloride 30mgMenthol 0.98mg

(Regal Spec)Anti-Histamine/Xanthine/Expectorant.

Form 5Rs. 20,000/-08-06-2016)Dy. No. 2523


Approved status in Pakistan, reference from other counteriesd not available

LocalHydrallineBySearle pharma

Deferred for confirmation of approval status of formulation by reference regulatory authorities.

718. -do- Regtus Oral Liquid suspension

Each 5ml contains:Paracetamol 80mg Pseudoephiderine Hcl 15mg.Chlorphenaramine maleate 1mg

(Regal Spec)Anti-Tussive / Antipyretic

Form 5Rs. 20,000/-08-06-20162478Dy. No.


Approved status in Pakistan, reference from other counteries not available

LocalReltus CF ByPharmatec


719. M/s Regal Pharmaceuticals, Plot # 2-A, Street

Regofer – F Oral Liquid

Form 5Rs. 20,000/-08-06-2016

Approved status in Pakistan, reference from other

Approved


# S-5 National industrial zone Rawat-Islamabad



Each 5ml contains:

Iron Ш hydroxide 352olymaltose complex eq. To elemental Iron 50mg

Folic Acid 0.35mg

(Regal Spec)Haematinic .

Dy. No. 2511


counteries not available

LocalApproved vide registration No.055272Rubifer-F- AGP

720. -do- Regacal Oral Liquid suspension

Each 5ml oral suspension contains:Paracetamol 120mg

(BP Spec)Anti-pyretic

Form 5Rs. 20,000/-08-06-2016)Dy. No. 2520


MHRA Almus Paracetamol BCM. Nottingham UK

LocalCalpolByGSK

Approved

LIQUID VIAL INJECTION (GENERAL)721. -do- Ciprocin Infusion

Each 100ml contains:Ciprofloxacin as lactate 200mg (USP Spec)

Quinolone Antibiotic

Form 5Rs. 20,000/- 08-06-2016Dy. No. 2474


FDA approved Cipro Bayer corporation pharmaceutical division USA

LocalNovidateBySami pharmaceutical

Approved

722. -do- CiprocinLiquid vial injection (Infusion)

Each 100ml contains:Ciprofloxacin as lactate 400mg (USP Spec)Quinolone Antibiotic

Form 5Rs. 20,000/-08-06-2016Dy. No. 2475


Qilox –Bosch Reference countires approval status required for proposed dosage form.


723. -do- Metrozole Infusion

Each 100ml contains:Metronidazole 500mg (USP Spec)

Form 5Rs. 20,000/-08-06-2016Dy. No. 2481


MHRA approved brand of Baxter

Flagyl –Sanofi

Approved


Nitroimidazole / Anti protozoal

724. -do- O – Mox Infusion

Each 250ml contains:Moxifloxacin (as HCl) 400 mg (Regal Spec)Quinolone Antibiotic

Form 5Rs. 20,000/-08-06-2016)Dy. No. 2484


FDA approved Avelox –Bayer \

Moxiget – Getz

Approved

725. -do- WEFLOX Infusion

Each 100 ml contains:Levofloxacin 500 mg (5mg/ml) (Regal Spec)

Floro Quinolone Antibiotic

Form 5Rs. 20,000/-08-06-2016Dy. No. 2476


MHRA Evoxil – Beacon

Leflox – Getzs

Approved

726. -do- Zolid Infusion 200mg

Each 100ml contains:Linzolid 200mg (Regal Spec)

Oxazolidinone Antibacterial

Form 5Rs. 20,000/-08-06-2016Dy. No. 2479


FDA approved Zyvox Pharmacia Upjohn pharmaceutical Newyork USA

LocalEcasilBySami





Form 5Rs. 20,000/-08-06-2016Dy. No. 2482



LocalEcasilBySami




Form 5Rs. 20,000/-08-06-2016Dy. No. 2483






LocalEcasilBySami

729. -do- PARAMOL Infusion

Each 100ml contains:Paracetamol 1gm (USP Spec)Antipyretic

Form 5Rs. 20,000/-08-06-2016Dy. No. 2480


MHRA approved product of Actavis

Provas - Sami


730. -do- Amikan Liquid injection

Each 2ml vial contains:Amikacin (as Sulphate) 250mg (BP Spec)Aminoglycoside Antibacterial

Form 5Rs. 20,000/-08-06-2016)Dy. No. 2505


FDA amikasin-Teva 250mg/ml

Srasil – Sami

Proof of approval of same dosage form in strength 250mg/2ml in reference countires is not correct.

Deferred for proof of approval of same formulation (250mg/2ml) by reference regulatory authorities.

731. -do- Amikan injection 500mg

Each 2ml contains:Amikacin (as Sulphate) 500mg (BP Spec)Aminoglycoside Antibacterial

Form 5Rs. 20,000/-08-06-2016)Dy. No. 2486


FDA approved Amikasin Teva

SrasilBySami


LIQUID AMPOULE INJECTABLE (GENERAL)

732. -do- V-REN Liquid injection Each 3ml ampoule Contains:Diclofenac sodium 75mg (Regal Spec)NSAID

Form 5Rs. 20,000/-08-06-2016)Dy. No. 2508


FDA approved Dyloject –Hospira

Dyclo – Indus

Approved

733. -do- Ondis injection

Each 4ml Ampoule Contains:Ondansetron 8mg (USP Spec)

Form 5Rs. 20,000/-08-06-2016Dy. No. 2510

Pack of 5 x 4ml / as per DPC

MHRA Ondansteron USA

LocalOnset injectionBy

Approved


Anti-emetic (5HT3 antagonist)

Pharmedic laboratories

734. -do- Ibro injection 3ml Each 3ml ampoule containsIbandronate monosodium monohydrate salt BP eq to ibandronic acid 3mg

BiophosphonateSpecification:- Manufacture

Form 5Rs. 20,000/-08-06-2016Dy. No. 2504


FDA approved Ibandronate Sodium Injection vial - Sun Pharmaceutical India

Bonviva – Roche

Approved

735. -do- Calcirol injection

Each 1ml Ampoule Contains:Calcitriol 1mcg (USP Spec)Vitamin D Analogue

Form 5Rs. 20,000/-08-06-2016)Dy. No. 2500


FDA approved CalitriolAmerical Regent pharmaceutical USA

LocalCalciwins injectionByWinsfield pharma

Approved

736. -do- Calcvit injection

Each 1ml Ampoule Contains:Cholicalciferol 5mg (Regal Spec)Vitamin D Analogue

Form 5Rs. 20,000/-08-06-2016Dy. No. 2515

Pack of 1X1ml / as per DPC

Vit D3 B.O.N, France

Indrop D – Neutro

Approved

737. Re-lac injection

Each 1ml Ampoule Contains:Ketorolac Trometamol 30mg (USP Spec)NSAID

Form 5Rs. 20,000/-08-06-2016Dy. No. 2485


USFDA Toradol – Roche

Molac – Linear

Approved

738. -do- Iron-C injection

Each 5ml Ampoule Contains:Iron sucrose complex equivalent to

Form 5Rs. 20,000/-08-06-2016)Dy. No. 2503

Pack of 5X5ml /

FDA approved Venofer 100mg/5ml Ampoule

Local

Approved


elemental iron 100mg (USP Spec)Hematinic

as per DPC Bislery-S injectionBySami pharma

739. -do- Regamin injection

Each 1ml amber glass ampoule Contains:Mecobalamin 500mcg (Regal Spec)Vitamin B12 co-enzyme

Form 5Rs. 20,000/-08-06-2016Dy. No. 2507



Mabil – Sami

Approved

740. -do- Regadol injection

Each 2ml Ampoule Contains:Tramadol Hcl 100mg (Regal Spec)Opiate Analogue

Form 5Rs. 20,000/-08-06-2016)Dy. No. 2509

Pack of10X1ml / as per DPC

MHRA Tramol –CSL

Lamadol – Brooks pharma

Approved

741. -do- Remol injection

Each 2ml Ampoule Contains:Paracetamol 300mg Lidocain Hcl 20mg (Regal Spec)NSAID / Local anesthetic

Form 5Rs. 20,000/-08-06-2016Dy. No. 2501

Pack of10X1ml / as per DPC

PaygoneinjectionByFynk pharmaceuticals

Proof of approval status of same dosage form in reference countires not provided.


742. -do- AQUA-RLiquid Ampoule injection 5ml Ampolue

Each 5ml Ampoule Contains:Sterile water for injection (BP Spec)

Vehicle/solvent/Diluent for parental administration

Form 5Rs. 20,000/-08-06-2016Dy. No. 2788

Pack of 100 X5ml / as per DPC

FDA approved Sterile water for injectionAmerical Regent pharmaceutical USA

LocalAqua -P injectionByIpram pharma

Approved

Evaluator-IV Salateen Waseem Philp


New Veterinary Licensed Unit M/s Vantage Pharmaceutical, 54/ R.B SARHALI, 6-KM SANGLA HILL ROAD SHAHKOT, FAISALABAD.





Remarks Decision

Veterinary Oral Liquid (General)743. M/s Vantage

Pharmaceutical, 54/R.B Sarhali, 6-km Sangla Hill Road, Shahkot, Faisalabad.

Bromodil oral Liquid

Each 100 ml contains: Tylosin Tartrate 10gmDoxycycline HCl 20gmBromhexine 1gm

(Manufcature Specification) Antibiotics

Form 5Rs. 20,000/-21-06-2016Dy. No. 254

Pack size 100ml, 500ml & one litre

Price decontrolled

Doctyl Super Solution – Alina

DML of firm approved in 247st meeting of Central Licensing Board held on 29-04-2016.

Approved

744. -do- Micotil 250 oral liquid

Each ml contains: Tilmicosin 250mg


Form 5Rs. 20,000/-21-06-2016Dy. No. 258

Pack size 100ml, 250ml, 500ml, one litre & 5 litrePrice decontrolled

Tilcosin 25% - Nawan

Approved

745. -do- ENROX TAGE 20% oral liquid

Each ml contains: Enrofloxacin 200 mg


Form 5Rs. 20,000/-21-06-2016Dy. No. 259


ENROCK -IPL Approved

746. -do- FOXIN TAGE oral liquid

Each ml contains: Florfenicol 230mgColistin Sulphate 50 MIU

Form 5Rs. 20,000/-21-06-2016Dy. No. 256

Pack size 100ml,

FLORICOL – DECENT

Approved



250ml, 500ml, one litre & 5 litrePrice decontrolled

747. -do- TAGE TRIL 10% oral liquid

Each 100 ml contains: Enrofloxacin 10gm (100 mg/ml)


Form 5Rs. 20,000/-21-06-2016Dy. No. 257


FLORICOL – DECENT

Approved

748. -do- SULFATRIN TAGE oral liquid

Each ml contains: Sulphadiazine 400mgTrimethoprim 80 mg


Form 5Rs. 20,000/-21-06-2016Dy. No. 262


TRISTAR - BIOGEN

Approved

749. -do- TIVERDOX oral liquid

Each 100ml contains: Doxycyclin HCl 20gmTylosin Tartrate 10gm


Form 5Rs. 20,000/-21-06-2016Dy. No. 250


MEDIDOX - MEDIVET

Approved

750. -do- FLORFEN 23 oral liquid

Each 100ml contains: Florfenicol 23gm


Form 5Rs. 20,000/-21-06-2016Dy. No. 251


BAFLOR 23 - BAARIQ

Approved

751. -do- MICROMUTIN oral liquid

Each 100ml contains: Tylosin Tartrate 10gmDoxycycline HCl 20gmColistin Sulphate 50000 IUBromhexine 0.5gm


Form 5Rs. 20,000/-21-06-2016Dy. No. 251


Tylo biotech – grand

Approved

752. -do- EAFLEXIN TAGE oral liquid

Each 100ml contains: Enrofloxacin 10gm

Form 5Rs. 20,000/-21-06-2016Dy. No. 252

ENROCOL 10% - LEADS

Approved


Colistin Sulphate 50,000,000 IU



Veterinary Oral Powder753. M/s Vantage

Pharmaceutical, 54/R.B Sarhali, 6-km Sangla Hill Road, Shahkot, Faisalabad.

Vantage ESB 30% Oral Powder

Each 100 gm contains: Sulphaclozine sodium monohydrate 30gm


Form 5Rs. 20,000/-21-06-2016Dy. No. 266

Pack size 100gm, 250gm, 500gm, 1kg & 5kgPrice decontrolled

E-COX ORAL POWDER - BIOGEN

DML of firm approved in 247st meeting of Central Licensing Board held on 29-04-2016.

Approved

754. -do- DOXY TAGE Oral Powder

Each 100 gm contains: Tylosin tartrate 10gmDoxycycline HCl 20gm


Form 5Rs. 20,000/-21-06-2016Dy. No. 261


DOXYTYL ORAL POWDER - NAWAL

Approved

755. -do- COLI TAGE 48 Oral Powder

Each gm contains: Colistin Sulphate 48000000 IU


Form 5Rs. 20,000/-21-06-2016Dy. No. 260


Deferred for confirmation of approval status of same formulation in Pakistan.

756. -do- TYL-D600 Oral Powder

Each 100 gm contains: Tylosin tartrate 20gmDoxycycline HCl 40gm


Form 5Rs. 20,000/-21-06-2016Dy. No. 263


REOCIN TD - DELUX

Approved

757. -do- OXYTAGE Oral Powder

Each 100 gm contains: Oxytetracycline HCl 25gmNeomycin Sulphate 25gmColistin Sulphate 30 MIU

Form 5Rs. 20,000/-21-06-2016Dy. No. 263

Pack size 100gm, 250gm, 500gm,

NEOCHLOR - ALINA

Approved



1kg & 5kgPrice decontrolled

758. -do- VANTAGE ASPER-C Oral Powder

Each 100 gm contains: Vitamin C 20gmAcetylsalicylic acid 6.7gm

(Manufcature Specification) Vitamin / antipyretic / anti inflammatory

Form 5Rs. 20,000/-21-06-2016Dy. No. 264


SB – ASPER- SB PHARMA

Approved

759. -do- SPECLIN TAGE Oral Powder

Each gm contains: Lincomycin HCl 222mgSpectinomycin HCl 444 mg


Form 5Rs. 20,000/-21-06-2016Dy. No. 265


The product in proposed strength is not yet registered in Pakistan.

Deferred for submission of registration application on prescribed Form 5-D as product in proposed strength is not yet registered in Pakistan.

760. -do- TYLOSTIN Oral Powder

Each 1000 gm contains: Tylosin Tartrate 100gmDoxycyclin HCl 200gmColistin Sulphate 480 MIUBromhexine HCl 3 gm


Form 5Rs. 20,000/-21-06-2016Dy. No. 268


Bronchodil – Attabak

The local availability is in liquid form while firm has applied for fwy powder.

Deferred for submission of registration application on prescribed Form 5-D as product in proposed strength is not yet registered in Pakistan.Deferred for confirmation of approval status of same formulation in Pakistan and reference regulatory authorities as already approved formulation are in liquid form while firm has applied for dry powder.

761. -do- CHLOR NEC Oral Powder

Each 1000 gm contains: Chlortetracyclin 80gmNeomycin Sulphate 70gmColistin Sulphate 4 gm


Form 5Rs. 20,000/-21-06-2016Dy. No. 269


STRIKER - WIMITS

Approved


762. -do- SPECLINX Oral Powder

Each 100 gm contains: Lincomycin HCl 5gmSpectinomycin HCl 7.5gmSpiramycin adipose 2.5gmBromhexine HCl 0.5 gm


Form 5Rs. 20,000/-21-06-2016Dy. No. 267


Spiralin –B (Attabak) import 249th meeting and 254th meeting

Approved

Evaluator-IV Salateen Waseem PhilpNew Section:-


Brand Name


Composition



Type of Form

Initial date, diary




Me-too status



Decision

Following cases of Azilsartan containing formulations were deferred in 259th meeting of the board:

Decision (259th meeting): Registration Board noticed that significant changes in the assay of the API have been occurred in Azilsartan formulations applied by different applicants. Therefore, all cases of azilsartan preparations were deferred for further deliberation in next board meeting.

1. Azil tablets (Azilsartan Medoxomil 20mg,40mg, 80mg), M/s Helix Pharma Karachi.

Drug Azil tablets (Azilsartan Medoxomil 20mg,40mg, 80mg)Source Jiangxi Synergy Pharmaceutical CO., Ltd. ChinaStorage Condition Real Time: 30°C and 65% RH

Accelerated: 40°C and 75% RHTime Period Real Time: 6 months


Accelerated: 6 monthsFrequency 0, 3, 6 monthsBatch Size 400 Tablets, 400 Tablets, 400 Tablets, No. of Batches 03Sample Size 25 tabletsMeeting Deferred 245th meeting of Registration

Board for stability data as per WHO guidelines.

Deferred in 255th meeting of registration board for evaluation by committee.

Remarks Significant change noticed in assay.

Documents / Data provided by the applicant (M/s Helix Pharma Karachi)

Sr. No. Documents to be provided Status

1. COA of API Yes

2. Approval of API by regulatory authority of country of origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin.

Yes (Photocopy provided)

3. Protocols followed for conduction of stability study and details of tests.

Yes

4. Data of 03 batches will be supported by attested respective documents like chromatograms, laboratory reports, data sheets etc.

Yes

5. Documents confirming import of API etc. Yes (By courier only)6. All provided documents will be attested (name, sign and

stamp) for ensuring authenticity of data / documents.Partially attested

7. Commitment to continue real time stability study till assigned shelf life of the product.

Yes

Decision: Registeration Board deliberated on the matter of significant changes in the assay of the API and decided to call technical team of firm for presentation on aforementioned point before the Board.

2. Azil tablets 80 mg, Co-Azil 40/25 mg, M/s OBS Karachi.

Drug 1. Azil tablets 80 mg, (Azilsartan Kamedoximil)2. Co-Azil 40/25 mg (Azilsartan Kamedoximi + Chlorothalidone)

Source 1.Jiangxi Synergy Pharma Co. Ltd, China2.Trichem Life Sciences India.


Storage Condition Real Time: 25°C and 60% RHAccelerated: 30°C and 65% RH

Time Period Real Time: 6 monthsAccelerated: 6 months

Frequency 0, 3, 6 months

Batch Size 2000 Tablets/ batch

No. of Batches 03

Sample Size 50 tablets

parameters Appearance, weight, dissolution, microbiology, assay,

Meeting Deferred 245th meeting of Registration Board for stability as per WHO guidelines.

Remarks Firm has submitted a request for grant of registration of Azil 40mg tablets and Co-Azil 40/12.5 mg based upon above data.Storage conditions not as per ICH Zone IV-A.Significant change noticed in assay.

Documents / Data provided by the applicant


1. COA of API Yes


Yes (Photocopies provided)

3. Protocols followed for conduction of stability study and details of tests. Yes


Yes

5. Documents confirming import of API etc. Yes (photocopy invoice submitted)

6. All provided documents will be attested (name, sign and stamp) for ensuring authenticity of data / documents.

Yes


Yes

Decision: Registeration Board deliberated on the matter of significant changes in the assay of the API and decided to call technical team of firm for presentation on aforementioned point before the Board

3. M/s Genix Pharma Pvt Ltd.

Drug Lalap Syrup 10mg/per m l (Lacosamide)


Source Nutra Specialties pvt Ltd 69, chandrapadiya village vinjamur mandal Nellore DT-524228 Indraspardash, India

Storage Condition Accelerated: 40°C±2°C/ 75% ±5% RHLong Term: 30°C±2°C/ 65% ±5% RH

Time Period Accelerated: 06 monthsLong Term: 24 months

Frequency 1,3,6,9,12,18,24months Batch Size 5Liters / batch

No. of Batches 03Sample Size 18 Packs Meeting Deferred in 252nd meeting of registration board

for stability data

Documents / Data provided by the applicants (M/s Genix Pharma Pvt Ltd, Karachi.)


1. COA of API Yes 2. Approval of API by regulatory authority of country of origin or

GMP certificate of API manufacturer issued by regulatory authority of country of origin.

Yes


Yes


Yes

5. Documents confirming import of API etc. Yes


Yes


Yes

Decision: Registration Board decided to constituted following panel for onsite investigation to confirm genuineness/ authenticity of stability data and associated documents, import of API, quality, specification, test analysis, facilities etc.

Director DTL Quetta (Chairman), Director DTL, Karachi; Area FID, DRAP (Member/Convener).


M/s CCL Labs, Lahore

4 M/s CCL Labs, Lahore

Diyacon TabletsEach tablet contains:Dapagliflozin 5mg

Form-5-DDuplicate fileRs.50,000/-As per SRO

New Molecule


Diyacon TabletsEach tablet contains:Dapagliflozin 10 mg


New Molecule

Drug Diyacon TabletsEach tablet contains:Dapagliflozin 5mg

Diyacon TabletsEach tablet contains:Dapagliflozin 10 mg

Source Beijing Huikang boyuan chemical company ltd, China Storage Condition Real Time: 30°C and 75% RH


Accelerated: 6 monthsFrequency 0,3,6Batch Size 3,000 Tablets per batch No. of Batches 3Sample Size 50 tablets per batch

Documents / Data provided by the applicants(M/s CCL Pharma Pvt Ltd, Lahore.)


1. COA of API Yes 2. Approval of API by regulatory authority of country of origin

or GMP certificate of API manufacturer issued by regulatory authority of country of origin.

Yes(Photocopy)


Yes



Yes

5. Documents confirming import of API etc. Yes (Commercial invoice not

attested) 6. All provided documents will be attested (name, sign and

stamp) for ensuring authenticity of data / documents.Yes


Yes

Decision: Registration Board decided to constituted following panel for onsite investigation to confirm genuineness/ authenticity of stability data and associated documents, import of API, quality, specification, test analysis, facilities etc.

Director DTL Peshawar (Chairman), Director DTL, Lahore; Area FID, DRAP (Member/Convener).


Dacvir TabletsEach film coated tablet contains:Daclatasvir Dihydrochloride equivalent to Daclatasvir ……30mgMfg Specs


New Molecule


Dacvir TabletsEach film coated tablet contains:Daclatasvir Dihydrochloride equivalent to Daclatasvir ……60mgMfg Specs


New Molecule

Drug Dacvir TabletsEach film coated tablet contains:Daclatasvir Dihydrochloride equivalent to Daclatasvir ……30mgMfg Specs

Dacvir TabletsEach film coated tablet contains:Daclatasvir Dihydrochloride equivalent to Daclatasvir ……60mg


Mfg Specs

Source Ruyuan HEC pharam Ruyuan county guangdond China Storage Condition Real Time: 30°C and 75% RH


Accelerated: 6 monthsFrequency 0,3,6Batch Size 1000 Tablets No. of Batches 3Sample Size 50 Tablets

Documents / Data provided by the applicants(M/s CCL Pharma Pvt Ltd, Lahore .)




The GMP certificate provided by the firm shows scope of inspection for bulk drug is (Azithromycin, Sofosbuvir, Ledipasvir)


Yes


Yes

5. Documents confirming import of API etc. Yes (Performa invoice not

attested) 6. All provided documents will be attessted (name, sign and

stamp) for ensuring authenticity of data / documents.Yes


Yes

Decision: Registration Board decided to constitute the following panel for onsite investigation to confirm genuineness/ authenticity of stability data and associated documents, import of API, quality, specification, test analysis, facilities etc.

o Brig. (R) M.H. Najmi, Member Registration Board. o Dr. Obaidullah, DDG (Reg-I), DRAP, Islamabad. o Dr. Saif ur Rehman Khattak, FGA, CDL, Karachi.


M/s Pharmevo, Karachi

8 M/s PharmEvo, Karachi

Dakvir tabletEach film coated tablet contains:Daclatasvir (as dihydrochloride) 60 mgMfg Specs

Form 5-DDuplicate fileRs: 50,000As per PRC

New Molecule

Drug Dakvir tabletEach film coated tablet contains:Daclatasvir (as dihydrochloride) 60 mgMfg Specs

Source Virupaksha organics India Storage Condition Real Time: 30°C and 75% RH


Accelerated: 6 monthsFrequency 0,3,6Batch Size 2500 Tablets No. of Batches 3Sample Size 50 Tablets

Documents / Data provided by the applicants(M/s Pharm Evo Pvt Ltd, Karachi .)




Yes(However the proof of approval of API not

attached )3. Protocols followed for conduction of stability study and details

of tests.No


Yes

5. Documents confirming import of API etc. Yes

6. All provided documents will be attessted (name, sign and stamp) for ensuring authenticity of data / documents.

Yes

7. Commitment to continue real time stability study till assigned Yes


shelf life of the product.

Decision: Registration Board decided to constitute the following panel for onsite investigation to confirm genuineness/ authenticity of stability data and associated documents, import of API, quality, specification, test analysis, facilities etc.

o Brig. (R) M.H. Najmi, Member Registration Board. o Dr. Obaidullah, DDG (Reg-I), DRAP, Islamabad. o Dr. Saif ur Rehman Khattak, FGA, CDL, Karachi.

M/s English Pharma Pvt Ltd, Lahore.

Drug Esovir 400mg Tablet (Sofosbuvir)Source M/s Pharmagen, LahoreStorage Condition Real Time: 30°C and 65% RH


Accelerated: 6 monthsFrequency 0,1,3,6Batch Size Not provided No. of Batches 3Sample Size Not provided

Documents / Data provided by the applicants(M/s English Pharma Pvt Ltd, Lahore.)


1. COA of API Yes2. Approval of API by regulatory authority of country of origin or

GMP certificate of API manufacturer issued by regulatory authority of country of origin.

Yes


No


Not Attested

5. Documents confirming import of API etc. Not Appied

6. All provided documents will be attessted (name, sign and stamp) for ensuring authenticity of data / documents.

No


No


Decision: Registration Board deferred case for completion of documents as recorded above.

M/s Getz Pharma, Karachi

9 M/s Getz Pharma, Karachi

Verna tablets 30 mgEach film coated Tablet :Daclatasvir dihydrochloride equivalent to Daclatasvir…………30mg

Form 5-DDy no: 365 dated: 08..09.2015Rs: 50,000Price: 30000/ 28 TabletsPrice; 1071.42/per tablet

New Molecule

10 M/s Getz Pharma, Karachi

Verna tablets 60 mgEach film coated Tablet :Daclatasvir…………60mg

Form 5-DDy no: 364 dated: 08..09.2015Rs: 50,000Price: 50000/ 28 TabletsPrice; 1785.42/per tablet

New Molecule

Drug Verna tablets 30 mgEach film coated Tablet :Daclatasvir dihydrochloride equivalent to Daclatasvir…………30mg

Verna tablets 60 mgEach film coated Tablet :Daclatasvir…………60mg

Source Zhejiang apeloa kangyu Pharmaceutical company limited Zhejiang, China



Frequency 0,1,2,3,6Batch Size Not available No. of Batches 3Sample Size Not available Remarks The firm has informed that they have developed


daclatasvir 60mg tablet from shanghai forefront pharma company Ltd China (contract development China- R&D company) and through technology transfer they have reproduced the same product at their facility. Further, Getz phama has manufacturer 03batches of the drug using same technology and 03months stability data has been completed.

Documents / Data provided by the applicants(M/s Getz Pharma Pvt Ltd, Karachi .)




The GMP certificate provided by the firm

shows scope of inspection for bulk drug

(Ofloxacin, levofloxacin,

rimantadine, Ubenimex)3. Protocols followed for conduction of stability study and

details of tests.Yes


Yes

5. Documents confirming import of API etc. NO


Yes


Yes

Decision: Registration Board deferred the case for scientifically rationale lab scale stability data for six months as per recommendatons of the Board.

M/s CCL Pharma, Lahore

11 Lebriva TabletEach Tablet contains:Ledipasvir……..90mgSofosbuvir………400mgMfg Specs

Form 5-DDy no: 705 dated: 08.02.2016Rs: 50,000Not applicable

Drug Lebriva TabletEach Tablet contains:Ledipasvir……..90mgSofosbuvir………400mgMfg Specs


Source Ruyuan HEC pharam Ruyuan county guangdond China Jiangxi Synergy Pharmaceutical Company limited China



Frequency 0,3,6Batch Size 1000 tablets No. of Batches 3Sample Size 50 Tablets

Documents / Data provided by the applicants(M/s CCL Pharma Pvt Ltd, Lahore .)


1. COA of API Yes(The firm has provided COA of two different companies )


Yes (Photocopy Provided)


Yes


Yes

5. Documents confirming import of API etc. Yes(not clear from the invoice that from which source the firm has imported the API)


Yes


Yes

Decision: Registeration Board deferred the case for clarification regarding source of API used for conducting stability studies.


Registration of Aprovasc Range (Irbesartan + Amlodipine).

Following case of M/s Sanofi Aventis, Karachi was discussed in 257 th meeting and decided as

follows:

Registration Board in its 245th meeting discussed following products of M/s Sanofi Aventis,

Karachi and advised the firm to provide status about availability of products in SRAs and provide safety

and efficacy data of the drugs along with complete clinical trial data of these formulations.

S. No Name of drug(s) & Composition

I. Aprovasc 300/10mg TabletEach tablet contains:Irbesartan……….300 mgAmlodipine besylate.14 mg eq. to amlodipine…10 mg(Antihypertensive, angiotensin II receptor antagonist)

II. Aprovasc 150/10mg TabletEach tablet contains:Irbesartan……….150 mgAmlodipine besylate.14 mg eq. to amlodipine…10 mg(Antihypertensive, angiotensin II receptor antagonist)

III. Aprovasc 150/5mg TabletEach tablet contains:Irbesartan……….150 mgAmlodipine besylate.7 mg eq. to amlodipine……5 mg(Antihypertensive, angiotensin II receptor antagonist)

IV. Aprovasc 300/5mg TabletEach tablet contains:Irbesartan……….300 mgAmlodipine besylate.7 mg eq. to amlodipine……5 mg(Antihypertensive, angiotensin II receptor antagonist)

In response, the firm had submitted that the fixed dose combination of Irbesartan + Amlodipine

(in the strength of Irbesartan 100mg /Amlodipine 5mg and Irbesartan 100mg /Amlodipine 10 mg) is

registered with PMDA Japan by the name of AIMIX by Daipinppon Suitomo Pharma. They have

submitted that as the dosing in Japan is considerably lower than the USA or Europe therefore the fixed

dose combinations are of lower strength.

They have informed that that three Bioequivalence studies have been conducted for Aprovasc and

the results of these had been submitted to DRAP for review and these studies show that the combination

of Irbesartan + Amlodipine versus free individual molecule is safe and well tolerated. Apart from these 2


randomized, open-label, multicenter, phase III trials were conducted and published in peer reviewed

index Journal, Clinical therapeutics (2012) and no untoward side effects were observed with this

combination other than those already reported for the individual drugs.

Registration Board in its 249th meeting discussed the case in view of the submission made by the firm and

following decision was taken:

“Registration Board referred the clinical data to Pharmacy Services Division for evaluation.”

Division of Pharmacy Services has now submitted evaluation report as under:

“The clinical study data attached by the company have been studied. The pharmacokinetic,

Pharmacovigilance, safety, efficacy data provided by the company was evaluated. The representatives of

the company who are involved in clinical research were asked to explain the need of combination

medicines and their beneficial effects on hypertension patients.

The research articles, studies carried out on the above combination medicine provided by the company

and the discussion made with the expert reveals that the products could be approved for registration. Such

combination products with Amlodipine and valsartan are already available in the market. The products

may be considered by the Registration Board after completing other required codal formalities”

Decision (257th meeting): Registration Board deferred the case for detailed deliberation in the light of report of Pharmacy Services Division.

Decision: Registeration Board deferred the case for further deliberation.


Item No.III: Biological Drugs Division.

Case No.01: Cases of imported human biological drugs from non reference countries.

”In 255th meeting of Registration Board it was apprised that registration applications for finished imported products are submitted with Certificate of Pharmaceutical Products (CoPP) and in some cases, CoPP is without any expiry date. The Board decided to consider such CoPP valid for 05 years from date of issuance. Moreover, Registration Board also decided to consider registration applications of those imported products whose CoPPs was valid at time of submission of application and later on expired during processing of the application. In such cases, application will be considered by Registration Board and firm will be advised to provide valid CoPP. Registration letter will be issued after submission of legalized CoPP after approval of chairman, RB. Accordingly the following cases require consideration by the Registration Board”

S.#. Name of Importer & Manufacturer

Brand Name & Composition

Type of FormDy No & Date of applicationFee submittedPack size/ Demanded Price

Document details (CoPP)Me too status/New molecule

Remarks Decision

1. M/s Medibid First floor, Shafi Court Merewether Road, Civil Lines, Karachi.

Shandong Kexing Bioproducts Co., Ltd.Mingshui development Zone, Zhangqiu, Shandong, China.

KXING-GCSF300ug/ml PFS

Recombinant human granulocyte colony-stimulating factor injection

Strength of active ingredients: 300ug/ml/Pre Filled Syringe

Form 5-A

Dy No. 2232 R&I dated 15-4-2013

Fee deposited Rs. 15000/- dated 19-4-2012 + Rs. 35000/- dated 13-11-2013 + Rs. 50000/- dated 12-1-2015


Pack size: 300ug/ml Pre filled syringe/small carton, 10 syringes/middle carton, 320 syringes/big carton

COPP No. WHO-CPP-CERT-JN-131211 dated 17-2-2013 from Republic of China

Product License No. GYZZ S20103004 dated 29-4-2010

Free Sale Certificate No. 2013-023 dated 17-2-2013 valid for two years

Valid and legalized COPP/ FSC along with GMP Certificate need to be submitted as per above decision of 255th meeting.

Condition of inspection abroad as per import policy.

Deferred for expert opinion of following and valid legalized COPP/FSC & GMP:

a. Brig. Tariq Satti, AFBMTC, Islamabad.

b. Brig. Qamar-un-Nisa, AFBMTC, Islamabad

c. Dr Shamsi, Karachi


Demanded Price. Rs.4500/- per vial.

2. M/s Medinet Pharmaceuticals, Rawalpindi

Probiomed S.A de C.V. San Esteban No.88, Col. Santo Tomas, C.P. 02020, Deleg, Azcapotzalco, D.F., Mexico.

FILATIL Prefilled Syringe 300MCG/1ML(Filgrastim)

Active ingredient: Filgrastim……300MCG/1ML

Antineoplastic

Shelf life : 24 months

Dy. No. 1798 (R&I) DRAP (TF)Dated 21-11-2014

Fee deposited: Rs. 50000/- dated 17-11-2014 + Rs.50000/- dated 15-3-2016

GMP Certificate No. 113300IT011473 dated 05-7-2011

Product Registration No. 101M2001S.S.A.

Free sale certificate No. 113300516B1305 dated 23-8-2011 valid until 24 months

Sanitary License No. 09 002 02 0001 Date of expiry 30-1-2009Date of translation 27 July, 2011





b. Brig. Qamar-un-Nisa, AFBMTC, Islamabad.

c. Dr Shamsi, Karachi


Probiomed S.A de C.V. San Esteban No.88, Col. Santo Tomas, C.P. 02020, Deleg, Azcapotzalco,

BIOYETIN Multi dose 10,000IU(Recombinant Human Erythropoietin)

Each 2ml vial contains: Recombinant Human Erythropoietin---

Dy No. 1164 (R&I) DRAP (TF) dated 26-2-2015

Fee deposited: Rs. 50000/- dated 26-2-2015 + Rs.50000/- dated 15-3-2016

As per DRAP policy


Free sale certificate No. 093300516B1213 dated 02-5-2009 valid until 24months from the




a. Dr. Ghias But, PIMS, Islamabad.


D.F., Mexico. --10,000IU

:Anti anemic agent Hematopoietic Growth Factor

country of origin.Product Registration No. 306M98 S.S.A.


b. Maj. Gen. Sohail Sabir, MH, Rawalpindi.

c. Dr.Sami siraj, KMU, Peshawar.



BIOYETIN PFS 4000IU(Recombinant Human Erythropoietin)

Strength & Active ingredients:One pack of Bioyetin 4000IU PFS Contains:Pre Filled Syringes of 0.30ML Each.

Recombinant Human Erythropoietin……4000IUPharmacological group:Antianemic agent Hematopoietic Growth Factor


Fee deposited:Rs. 50000/- dated 26-2-2015 + Rs.50000/- dated 15-3-2011.


Free sale certificate letter No.093300516B1213 dated 02-5-2009 valid until 24 months from the country of origin.

Product Registration No. 306M98 S.S.A.

Sanitary License No. 09 002 02 0001 Date of expiry 30-1-2009Date of




a. Dr. Ghias But, PIMS, Islamabad.

b. Maj. Gen. Sohail, MH, Rawalpindi.

c. Dr.Sami siraj, KMU, Peshawar.


translation 27 July, 2011



BIOYETIN PFS 2000IU(Recombinant Human Erythropoietin)

Strength & Active ingredients:One pack of Bioyetin 2000IU PFS Contains:Pre Filled Syringes of 0.30ML Each.

Recombinant Human Erythropoietin……2000IUPharmacological group:Antianemic agent Hematopoietic Growth Factor

Dy No. 1166 (R&I) DRAP (TF)Dated 26-2-2015

Fee deposited: Rs. 50000/- dated 26-2-2015 + Rs. 50000/- dated 15-3-2016.


Free sale certificate letter No.093300516B1213 dated 02-5-2009 valid until 24 months from the country of origin.

Product Registration No. 306M98 S.S.A.





a. Dr. GhiasBut, PIMS, Islamabad.

b. Maj Gen. Sohail, MH, Rawalpindi.

c. Dr.Sami siraj,, KMU, Peshawar

6. M/s La-Vie (Pvt) Ltd., Lahore

ManufacturerM/s xiamen Innovax Biotech Co., Ltd., 130.Xinyuan Road, Haicang District,

Hecolin ® 0.5ml/dose PFSEach 0.5ml dose contains:-30 ug of purified recombinant Hepatitis E virus antigen


Dy. No. 2224 (R&I) DRAP (TF)Dated 12-5-2016

Fee deposited: Rs. 50000/- dated 10.5.2016

New molecule

GMP Certificate No. CN20120056 dated 09-7-2012 valid upto 08-7-2017

Free Sale Certificate No.

The new molecule for treatment of hepatitis E require expert evaluation from hepatalogists.

Condition of inspection abroad as per import policy will

Deferred for confirmation of approval status by reference regulatory authorities and expert opinion of following pertaining to requirement of Hepatitis E


Exiamen, Fujian Province, PR China.

2016002 dated 8.1.2016

prevail. virus vaccine in country, keeping in view its prevelance,epidemiology, domestic requirement etc.

a. Dr. Huma Qureshi, PHRC, Islamabad

b. Prof, Dr. Umar, Holy Family Hospital, Islamabad


Manufacturer M/s BMI Korea Co., Ltd., 11,7 Gill, Chedanro, Jeju-si, Jeju-do, 690,140 Korea.

Hirax InjectionEach 0.5 ml (vial) contains:-

Hyaluronidase……. 750 IU

Enzyme

(Enhance permeation of Subcutanious or Intramuscular Injections, local anesthetics and subcutaneous infusions.)

Dy. No.886 (R&I) DRAP (TF)Dated 15-2-2016

Fee deposited: Rs. 50000/- dated 08.2.2016.

New molecule

CoPP No. 2014-F1-0121 dated 24.4.2014 (validity not mentioned)

GMP Certificate No. 2014-F1-0172 dated 07-7-2014Free Sale Certificate No. 2014-F1-0120 dated 24.4.2014

Evidence of availability in reference drug agencies is required.

Deferred for confirmation of approval status by reference regulatory authorities including indications.


Manufacturer M/s BMI Korea Co., Ltd., 11,7

Hirax InjectionEach 1ml (vial) contains:-Hyaluronidase……. 1500 IU

(Enhance

Dy. No.4666 (R&I) DRAP (TF)Dated 28-7-2015

Fee deposited: Rs. 50000/- dated 09.7.2015

New molecule

CoPP No. 2014-F1-0121 dated 24.4.2014GMP

Product is available internatioally in reference agencies under the name of HYLASE of

Deferred for confirmation of approval status by reference regulatory authorities including


Gill, Chedanro, Jeju-si, Jeju-do, 690,140 Korea.

permeation of Subcutanious or Intramuscular Injections, local anesthetics and subcutaneous infusions.)

Certificate No. 2014-F1-0172 dated 07-7-2014Free Sale Certificate No. 2014-F1-0120 dated 24.4.2014

Wockhardt UK as freeze dried formulation (powder) in ampoule, however tha applied product is solution in vial. The lyphollized formulation is included in BP.

indications.

9. Venture Pharmaceuticals (Pvt) Ltd, Karachi.

Bharat Serums and Vaccines Limited Plot No. K-27, Anand Nagar, Additional M.I.D.C.Ambernath (East), India

RHOCLONE 300 MCG

Anti Rho-D Immunoglobulin Injection (Monoclonal) (Liquid Injection)

Each ml contains:Anti Rho-D Immunoglobulin….300mcg/ 1500 IU

Water for Injection U.S.P…q.s

Immune Sera and ImmunoglobulinAnti-D (Rh) ImmunoglobulinATC code: J06B B01


Form-5A

Dy. No. 1218 (R&I) DRAP dated 25-2-2016

Fee Deposited: Rs.100000/- dated 03-2-2016

vial

Legalized Valid COPP No. COPP/CERT/KD/42264/2016/11/14803/73243 valid up to 01-10-2016

Product License No. KD5 in Form 28EDated 07-2-2011

Legalized GMP Certificate No. NEW-WHO-GMP/CERT/KD/12788/2014/11/6320 dated 04-4-2014

The product was discussed in the 257th meeting and deferred for submission of vaild legalized CoPP. Now the Firm has submitted Valid legalized CoPP valid upto 01-10-2016.

Evidence of availability in reference drug agencies is required as the Pharmacopieal preparation (BP) contains specific antibodies against erythrocyte D- antigen and may also contain small quantities of other blood-group antibodies. However the applied formulation contains only IgG antibodies.

Deferred for

a. Confirmation of approval status by reference regulatory authorities.

b. References pharmacopias

c. Importability as per import policy order from India

d. Safety profile, clinical efficacy, and clarification as the Pharmacopieal preparation (BP) contains specific antibodies against erythrocyte D- antigen and may also contain small



quantities of other blood-group antibodies. However the applied formulation contains only IgG antibodies.

10. M/s Opulent International Karachi.

M/s Reliance Life Sciences, of Dhirubhai Ambani Life Sciences Center (DALC),Plant No. 4B, Plot No. R-282, TTC Area of MIDC, Rabale Thane Belapur Road Navi Mumbai India.

ALBUREL (Human Normal Albumin IP 20%)

Each 100 ml vial contains:Total protein….200g/LSodium Caprylate…..6.65g/ LNa+ not more than…160mM/LK+ not more than…..2mM/ LAluminum…..≤200µg/ L

Human Albumin –Plasma protein


Form-5A

Dy. No 1120 dated 28-05-2014

Rs.100000 dated 28-06-2013

60USD / vial

Legalized CoPP/CERT/ KD/42047/2016/11/14718/72804 dated 30-4-2016 valid upto 31-12-2017

As per COPP, the product is licensed to be placed in the market for use in the exporting country; however product is not available in the market in the country of origin.


Deferred for clarification about non abailability of product in the country of origin and valid reason thereof by the regulatory body and confirmation of availability of similar products in country.


M/s Reliance Life Sciences, of Dhirubhai Ambani Life Sciences Center

ALBUREL (Human Normal Albumin IP 20%)

Each 50 ml vial contains:Total protein….200g/

Form-5A

Dy. No 1119 dated 28-05-2014

Rs. 100000 dated 28-06-2013

30USD / vial

Legalized CoPP/CERT/ KD/42047/2016/11/14718/72804 dated 30-4-2016 valid upto 31-12-2017

As per COPP, the product is licensed to be placed in the market for use in the exporting country; however product is not available in the

Deferred for clarification about non abailability of product in the country of origin and valid reason thereof


(DALC),Plant No. 4B, Plot No. R-282, TTC Area of MIDC, Rabale Thane Belapur Road Navi Mumbai India.

LSodium Caprylate…..6.65g/ LNa+ not more than…160mM/LK+ not more than…..2mM/ LAluminum…..≤200µg/ L

Human Albumin –Plasma protein


market in the country of origin.


by the regulatory body and confirmation of availability of similar products in country.


M/s Reliance Life Sciences, Pvt Limited, Plant-1 Sandhra Textile Mills Compound, Ground and First Floor C.S. No. 1621 Plot No. 3 Plan 1 Pandurang Budhkar, Marg Worli Mumbai.

IMMUNOREL(Human Normal Immunoglobulin for Intravenous Administration)

Each 50ml contains:

Protein…..50g/ LIgG…..2.5gStabilizer Maltose…..100g/LIgA content≤ 80mg/LIgG subclases……Normal distribution

Immunoglobulins


Form-5A

Dy. No 11198 dated 28-05-2014

100000 dated 28-06-2013

98 USD / vial

Legalized CoPP /CERT/MD/26507/2015/11/10485/48262 dated 28-4-2015 valid upto 09-3-2017

As per COPP, the product is licensed to be placed in the market for use in the exporting country; however product is not available in the market in the country of origin.


Deferred for clarification about non abailability of product in the country of origin and valid reason thereof by the regulatory body and confirmation of availability of similar products in country.


13. M/s Hakim sons (Impex) Pvt Limited, Hakim sons Building, 19 West Warf Road, Karachi Pakistan

M/s Bharat Serum and Vaccines Limited, Plot No K-27 Anaa nd Nagar, Additional MIDC Ambernath (East) India.

HuCoG- 5000 HP

Each vial contains:Chorionic Gonadotropin BP……5000 I.U

Gonadotropins

Indications:An ovulatory Fertility, Hypogonadism and Cryptorchidism


Form-5A

Dy No. 279 R&I dated 15-01-16

Fee Rs.100000/- dated 12-01-2016

Legalized CoPP No: CoPP/ CERT/ KD/ 16870/ 2014/ 11/ 6610/ 292156/ valid up to 01-04-2016

Legalized GMP No: New-WHO-GMP/ CERT/ KD/ 12788/ 2014/ 11/ 6320 valid up to 01-04-2016



Deferred for submission of valid legalized COPP, confirmation of availability of similar products in country and expert opinion of following:

a. Brig. Muzamil Hussain Najmi, Member Registration Board

b. Brig, Aamir Ikram, AFIP, Rawalpindi.

c. Dr. Masud-ur-Rehman, DDG, DRAP

14. M/s Hakim sons (Impex) Pvt Limited, Hakim sons Building, 19 West Warf Road, Karachi Pakistan

M/s Bharat Serum and Vaccines Limited, Plot No K-27 Anaa nd Nagar, Additional MIDC Ambernath

BSV HUMOG 75 HP

Each vial contains:Menotropin BP equivalent to activity ofFollicle Stimulating Hormone……75 IULuteinizing Hormone……75IU

Hormone

Form-5A

Dy No. 280 R&I dated 14-01-16

Fee Rs.100000/- dated 12-01-2016

Legalized CoPP No: CoPP/ CERT/ KD/ 26812/ 2015/ 11/ 10547/ 48878/ valid up to 01-04-2016

Legalized GMP No: New-WHO-GMP/ CERT/ KD/ 12788/ 2014/ 11/ 6320 valid up to 01-04-2016



Deferred for submission of valid legalized COPP, confirmation of availability of similar products in country and expert opinion of following:

a. Brig. Muzamil Hussain Najmi, Member Registration Board


(East) India. Shelf Life: 36 months

b. Brig, Aamir Ikram, AFIP, Rawalpindi.

c. Dr. Masud-ur-Rehman, DDG, DRAP

15. Hospital Services & Sales 13-C Annexe, Block 6, P.E.C.H.S, Shahrah-e-Faisal, Karach 75400.

Manufacturer:M/s. Reliance Life Sciences, LimitedDhirubhai Ambani Life Sciences Center (DALC), R-282, TTC Industrial Area, Thane Belapur Road, Rabale, Navi Mumbai, Maharashtra,India

EPOREL-10,000 I.U PFS

Each 1.0ml contains:Erythropoietin concentrated (rhEPO) Ph Eur ……10,000

Blood Forming Agent


Form 5A

10-10-2014

Fee Rs.100000/- dated 10-10-2014

Rs. 6086/- pack of 1’s

Legalized Free Sale Certificate No. D&C/841/201110/-00525-4 Dated 09-11-2011

Legalized CoPP provided, valid up to 19-03-2014

Product License No. KD/7Dated 28-04-2014

Legalized GMP provided, valid up to 19-03-2014.



Deferred for submission of valid legalized COPP and expert opinion of following:

a. Dr. Toqeer Raza, NUST, Islamabad

b. Dr. Huma Qureshi, PMRC, Islamabd

c. Dr. Sami J Khan


Manufacturer:M/s. Reliance Life Sciences,

EPOREL-2000 I.U PFS

Each 0.5ml contains:Erythropoietin concentrated (rhEPO) Ph Eur ……2000

Blood Forming

Form 5A

10-10-2014

Fee Rs.100000/- dated 10-10-2014



Legalized CoPP provided, valid up to 19-03-


Condition of inspection abroad as per import

Deferred for submission of valid legalized COPP and expert opinion of following:



LimitedDhirubhai Ambani Life Sciences Center (DALC), R-282, TTC Industrial Area, Thane Belapur Road, Rabale, Navi Mumbai, Maharashtra,India

Agent


2014



policy. b. Dr. Huma Qureshi, PMRC, Islamabd

c. Dr. Sami J Khan


Manufacturer:M/s. Reliance Life Sciences, LimitedDhirubhai Ambani Life Sciences Center (DALC), R-282, TTC Industrial Area, Thane Belapur Road, Rabale, Navi Mumbai, Maharashtra,India

EPOREL-4000 I.U PFS

Each 0.4 ml contains:Erythropoietin concentrated (rhEPO) Ph Eur ……4000

Blood Forming Agent


Form 5A

10-10-2014

Fee Rs.100000/- dated 10-10-2014








Deferredfor submission of valid legalized COPP and expert opinion of following:


b. Dr. Huma Qureshi, PMRC, Islamabd

c. Dr. Sami J Khan

18. Hospital Services & Sales 13-C Annexe, Block 6, P.E.C.H.S, Shahrah-e-

APIGRAST 300µg PFS

Each 0.5ml contains:Filgrastim

Form-5A

02-09-2014

Fee Rs.100000/- dated 02-09-2014

Legalized Free Sale Certificate No. D&C/841/201110/-00525-4 Dated 09-11-

Valid and legalized COPP/ FSC along with GMP Certificate need to be submitted as per

Defered for expert opinion of following and valid legalized COPP/FSC &


Faisal, Karach 75400.

Manufacturer:M/s. Reliance Life Sciences, Pvt LimitedDhirubhai Ambani Life Sciences Center (DALC), R-282, TTC Industrial Area, Thane Belapur Road, Rabale, Navi Mumbai, Maharashtra,India

concentrated solution Ph. Eur… 300µg

Antineoplastic and Immunomodulator


Rs.4910/- Pack of 1’s

2011



Legalized GMP provided, valid up to 19-03-2014

above decision of 255th meeting.


GMP:


b. Brig. Qamar-un-Nisa, AFBMTC, Islamabad.

c. Dr Samsi Karachi


Manufacturer:M/s. Reliance life sciences Pvt. Ltd.,Dhirubhai Ambani Life Sciences Center (DALC), R-282, TTC Industrial Area, Thane Belapur Road, Rabale, Navi Mumbai, Maharashtra,INDIA.

CARDIRAL 18mg/ 10Units Per Vial (Sterile lyophilized powder for injection)

Each vial contains:Reteplase (Recombinant Tissue Plasminogen Activator) …….…. 18mgTranexamic acid... 8.32mg.

Antithrombotic


Form 5A

100000 dated 02-09-2014

47188/- pack of 2 single use vials, 2 ampoules of 10ml sterile water of injection, 2 single use 10 ml syringes, 4 sterile needles.







Tranexamic acid is used as excipient in formulation which require clarification from the firm.

Deferred for confirmation of approval status by reference regulatory authorities, local availability of similar products and provision of valid legalized COPP/FSC & GMP.

20. Hospital APFERON Form 5A Legalized Free Valid and Deferred for


Services & Sales 13-C Annexe, Block 6, P.E.C.H.S, Shahrah-e-Faisal, Karachi 75400.

Manufacturer:M/s. Reliance life sciences pvt. Ltd.,Dhirubhai Ambani Life Sciences Center (DALC), R-282, TTC Industrial Area, Thane Belapur Road, Rabale, Navi Mumbai, Maharashtra,INDIA.

5MIU vial Each 0.5ml contains:rH Interferon alfa 2b Ph. Eur. …………..… 5 MIU

Cytokines and Immunomodulator

Shelf life : 2years

100000 dated 02-09-2014


Sale Certificate No. D&C/841/201110/-00525-4 Dated 09-11-2011




legalized COPP/ FSC along with GMP Certificate need to be submitted as per above decision of 255th meeting.


submission of valid legalized COPP and expert opinion of following:

a. Prof. Dr. Muhammad Umar, Holy Family Hospital, Islamabad.

b. Dr. Huma Qureshi, PMRC, Islamabad.

c. Dr. Nasir Jalal, NUST, Islamabad.

21. Hospital Services & Sales 13-C Annexe, Block 6, P.E.C.H.S, Shahrah-e-Faisal, Karachi 75400.

Manufacturer:M/s. Reliance life sciences pvt. Ltd.,Dhirubhai Ambani Life Sciences Center (DALC), R-282, TTC Industrial Area, Thane Belapur

APFERON 3MIU vial Each 0.5ml contains:rH Interferon alfa 2b Ph. Eur. …………..… 3 MIU

Cytokines and Immunomodulator

Shelf life : 2years

Form 5A

100000 dated 02-09-2014







Defered for submission of valid legalized COPP and expert opinion of following:





Road, Rabale, Navi Mumbai, Maharashtra,INDIA.



Manufacturer:M/s. Reliance life sciences pvt. Ltd.,Dhirubhai Ambani Life Sciences Center (DALC), R-282, TTC Industrial Area, Thane Belapur Road, Rabale, Navi Mumbai, Maharashtra,INDIA.

RELIBETA 30µg – 0.5ML PFS (

Each 0.5ml in PFS contains:Recombinant Interferon beta 1a …………… 30µg

Cytokines

Shelf life: 2 years

Form-5A

10-10-2014

Deposited fee100000

30430/- Pack of 1’s







Defered for submission of valid legalized COPP and expert opinion of following:




23. The Searle Company Ltd First floor NICL Building Abbasi Shaheed Road , Karachi 75530

Product License Holder Address

Laboratorio ELEA

TUXIMAB Injection 100mg/10ml

Each vial contain 100mg/10ml of Rituximab

Indication:

Non-Hodgkin’s Lymphoma Chronic

09 -6-2015

Fee Deposited

Rs.100000/- vide challan No. 0233078 dated 18-5-2015

Balance fee

Nil

CoPP letter No .20132019 000140 dated 17-4-2015 valid for twelve months.

Prod Reg No.57.279 date of issuance 16th October, 2013. Issued by anmat Argentina.



Deferred for submission valid legalized COPP and expert opinion of following:

a. Gen. Iftikhar, CMH, Rawalpindi.


S.A.C.I.F.y.A..Sanabria No 2353 C1417AZECiudad Autonoma de Buenos Aires, Republica argentina

API Manufacturing Site:Pharm ADNCarlos Villate 5148, Buenos aires, Argentina

Finished Manufacturing & Packaging site:SINERGIUM BIOITECH S.A.Ruta 9km 38.7 – Grain – Prov. De, Buenos Aires, Republica argentina

Lymphocytic Leukemia Rhematoid ArthritisGranulomatosis with Polyangitis (previously termed wegner’s Granulomatosis) and microscopic polyangitis.

Pharm ADNGMP Certificate No. 20132014 000791 14 dated 09-6-2014

SINERGIUM BIOITECH S.A.GMP Certificate No. 20132014 001894 14 dated 14-2-2015

Documents Legalized and notarized.

b. Dr. Humera Mehmood, Consultant of Oncolologist NORI, Islamabad.

c. Dr. Saleem Siddique, Shifa International, Islamabad.

24. The Searle Company Ltd First floor NICL Building Abbasi Shaheed Road , Karachi 75530

Product License Holder Address

TUXIMAB Injection 500mg/50ml

Each vial contain 500mg/50ml of Rituximab

Indication:

09 -6-2015

Fee Deposited

Rs.100000/- vide challan No. 0233077 dated 18-5-2015

Balance fee

Nil

COPP letter No.20132019 000142 15 dated 17-4-2015

Prod Reg No. 57. 279 dated 16-10-2013 Issued by anmat


Condition of inspection abroad as per import

Deferred for submission valid legalized COPP and expert opinion of following:

a. Gen. Iftikhar, CMH,


Laboratorio ELEA S.A.C.I.F.y.A..Sanabria No 2353 C1417AZECiudad Autonoma de Buenos Aires, Republica argentina

API Manufacturing Site:Pharm ADNCarlos Villate 5148, Buenos aires, argentina

Finished Manufacturing & Packaging site:SINERGIUM BIOITECH S.A.Ruta 9km 38.7 – Grain – Prov. De, Buenos Aires, Republica argentina

Non-Hodgkin’s Lymphoma Chronic Lymphocytic Leukemia Rhematoid ArthritisGranulomatosis with Polyangitis (previously termed wegner’s Granulomatosis) and microscopic polyangitis.

Argentina.

Pharm ADNGMP Certificate No. 20132014 000791 14 dated 09-6-2014

SINERGIUM BIOITECH S.A.GMP Certificate No. 20132014 001894 14 dated 14-2-2015

Documents Legalized and notarized.

policy. Rawalpindi.

b. Dr. Humera Mehmood, Consultant of Oncolologist NORI, Islamabad.

c. Dr. Saleem Siddique, Shifa International, Islamabad.

25. M/s Hakimsons (Impex) Pt Ltd Karachi

M/s SOVEREIGN PHARMA PVT.LTD, S urvey no.46/1-4, Kadaiya

Sterilezed water for Injection for VaxiRab-N (Purified Chick Embryo Cell Culture Rabies Vaccine.

Each 1ml Vial water for Inj

Form 5-A

Dy No. 768 Dir (BD) dated 24-12-2-13

Fee deposited Rs.50000/- dated 29-10-2013 + 50000/- dt 12-12-

Legalized COPP NO. DD-449/1/D/2011 valid upto 29-11-2013 submitted


Condition of

Approved as diluent for exclusive use of VaxiRab-N vaccine and as per Import Policy for finished drugs.


Village nanai Daman-396210 India

Diulent

Shelf life 05year

2014

Unit price: Free of Cost

inspection abroad as per import policy.

The firm will provide valid legalized COPP and Chairman Registration Board will allow the issuance of registration letter.

Case No. 02: Cases of imported veterinary biological drugs from non reference countries

Sr. No

Name of Importer & Manufacturer


Type of Form

Dy No & Date of application

Fee submitted

Pack size/ Price

Document details (CoPP)

Me too status/New molecule

Remarks Decision

1. M/s Al-Asar Enterprise, Multan

Malaysian Vaccines and Pharmaceuticals, Lot 11182, Batu 20 Jalan Puchong, Kajang, Pulau Meranti, Off Cyberjaya 47100 Puchong Selangor, Malaysia.

MYVAC IBD V877(Infectious Bursal Disease V877 vaccine)

Each dose contains:Infectious bronchitis virus strain V877 ……..10 2.5EID 50

Active immunization of chickens against IBD

Shelf life: 2 yearsRoute of Adm: oral via drinking water, Intraocular and Intranasal

Form-5A

Dy. No. 1916 dated 24-05-16

Fee Rs. 100000/- dated 24-05-16

Decontrolled/ 1000 doses per vial, 10 vials per pack

Legalized Free Sale certificate dated 23-12-2015

Legalized GMP dated 27-09-2020

Me too


Approved as per Import Policy for finished drugs and valid legalized COPP.




MyVAC NDV 4HR(New Castle Disease Vaccine)

Each dose contains:New castle disease V4 Heat resistant virus strain………106.0

EID 50

Active immunization of chickens anew castle disease virus

Shelf life: 2 yearsRoute of Adm: oral via drinking water, Intraocular and Intranasal

Form-5A

Dy. No. 2583 dated 13-06-16

Fee Rs.100000/- dated 13-06-2016




Me too





MyVAC Fowl Pox(Beaudette strain vaccine)

Each dose contains:Fowl Pox live virus Beaudette Strain………102.6

EID 50

Active immunization of chickens against fowl pox

Shelf life: 2 yearsRoute of Adm: wing web, intraocular, Intramuscular

Form-5A

Dy. No. 2582 dated 13-06-16

Rs.100000/- dated 13-06-2016




Me too






IBD UPM93(Infectious Bursal Disease Vaccine)

Each dose contains:IBD Live virus strain UPM 93 ………102.5 EID 50

Active immunization against IBD in broilers and layer chickens

Route of Adm: Drinking water, eye drop routeShelf life: two years

Form-5A

Dy. No. 2581 dated 13-06-16

Fee Rs.100000/- dated 13-06-2016




Me too





MYVAC ND EMULSION

(Inactivated oil adjuvant Newcastle disease vaccine B1 Type LaSota)

Each dose contains:New castle disease virus LaSota strain ≥ 108.5 EID 50

Active immunization against new castle disease

Shelf life: 2 yearsRoute of Adm: SC/ IM

Form-5A

Dy. No. 1915 dated 24-05-16

Fee Rs.100000/- dated 13-06-2016




Me too






MYVAC 102

(New castle disease B1 type LaSota Strain)

Each dose contains:New castle disease virus LaSota strain:…… 105.5 EID 50

Active immunization against new castle disease

Shelf life: 2 yearsRoute of Adm: oral route, intraocular route and intranasal

Form-5A

Dy. No. 1917 dated 24-05-16

Fee Rs.100000/- dated 13-06-2016




Me too





MYVAC 202(Combined New castle disease & Infectious bronchitis vaccine)

Each dose contains:

New castle disease virus B1 Type, LaSota strain… 105.5 EID 50

Infectious bronchitis virus Massachusetts type H120 strain…. 103.1

EID 50

Form-5A

Dy. No. 1917 dated 24-05-16

Fee Rs.100000/- dated 13-06-2016




Me too




Active immunization against ND and IBD

Shelf life: 2 yearsRoute of Adm: oral route, intraocular route and intranasal

8. Hospital Services & Sales 13-C Annexe, Block 6, P.E.C.H.S, Shahrah-e-Faisal, Karachi 75400.

Parent Company/Lic. Holder:QYH Biotech Company Ltd.,Building. No. 20, Part 11, ABP, No. 188, Southwest 4th Ring Road, Fengtai District, Beijing, China.

Manufacturing Site:Zhengzhou Bio-Pharmaceutical Factory of QYH Biotech Co. Ltd., Shibalihe, South Surburb,

QYH-ND IB EDS (Newcastle Disease, Infectious Bronchitis & Egg Drop Syndrome Vaccine, Inactivated)

Each one dose contains:- Inactivated Newcastle Disease virus La Sota strain (the virus titer is ≥ 3x108.0EID50/ 0.1ml before inactivation), inactivated Infectious Bronchitis virus M41 strain (the virus titer is ≥ 3x106.0EID50/ 0.1ml before inactivation) and inactivated Egg Drop

22-Dec-10

Deposited fee100000/-

Balance FeeNil

Pack Sizes:(250mL / Bottle)

Legalized Free Sale Certificate No. (2011) 160132129 Dated 01-06-2013

Legalized CoPP No. 3 Dated 10-12-2015

Product License No. (2010) 01008Dated 09-03-2010

Legalized GMP Certificate No. (2014) 220Dated 16-10-2014


Deferred for confirmation of local availability/ approval of similar vaccine.


Zhengzhou City, Henan Provice, P. R. China.

Syndrome virus AV127 strain (the HA titer of the virus is ≥ 1:30720 before inactivation),

(For Veterinary Use)

9. Tarobina Corporatin , New Garden Town, Lahore

Choong Ang Vaccine Laboratories co., Ltd. 1476-37 Yuseong-daero, Yuseong-gu, daejeon, Korea 305-348

Bovishot® Ephemer(Bovine ephemeral fever virus live vaccine)

Composition per dose (2.0ml/dose)Bovine ephemeral fever virus….≥ 103.0TCID50/doseStablizer…50%

Uses: For control and preventin of bovine ephemeral fever caused by BEFV in cows.

Shelf life: Twelve(12) months

Route: Subcutanously Injection(For Veterinary Use)

Form-5(A)

Dy No. 4913 (R&I) DRAP dated 05-8-2015

Fee deposited Rs. 100000/- dated 03-8-2015

Dosage: 3doses/bottle

Maximum Retail Price: Rs. 2115/-

Legalized FSC dated 26-6-2015.

Legalized GMP Certificate dated 22-5-2015


Deferred for expert opinion pertaining to prevelance, epidemiology, domestic requirement etc.

from following:

a. Dr. Qurban Ali, NVL, Islambad

b. Dr. Masood Rabbani, UVAS, Lahore.

c. Dr. Arif Awan, CASVAB Quetta.

10. M/s Vetline International ,

ITA ND + IB(Inactivated

Form 5-A Copy of GMP Certificate No.

Legalized valid Free sale

As the firm has provided valid


Lahore, Pakistan

CEVA-PHYLAXIA Veterinary Biologicals Co. Ltd., Horog u. 32-34. 1107 Budapaest HUNGARY

Injectable emulsion Vaccine for active Immunization of chickens against Newcastle disease (ND) and infectious Bronchitis (IB).

-50 pd50 of Inactivated Newcastle disease Virus, strain LaSota.-induced min . 6 log2 HI, of Inactivated Infectious bronchitis virus, strainPharmacologial group: Avian inactivated vaccine

Route administratin: Subcutaneously or Intramuscularly

Uses: Vaccine is recommended for the vaccination of breeder and lying type chikens flocks, previously immunization against Newcastle disease and infectious bronchitis with

Dy No. 1497 R&I DRAP dated 05-5-2016.


CG-HU/09V/2014

DML No. MA-HU/04V/2009/M1. Dated 04-11-2014 Hungary.

certificate along with GMP/ CoPP is required.

legalized FSC ((02.2/3442-2/ 2016 dated 10-06-2016) and GMP certificate (02.2/3442-5/ 2016 dated 10-06-2016) and Registration Board considerd the documents and approved the product as per Import Policy for finised drugs.


attenuated live virus vaccine.

11. M/s Vetline International , Lahore, Pakistan

CEVA-PHYLAXIA Veterinary Biologicals Co. Ltd., Horog u. 32-34. 1107 Budapaest HUNGARY

ITA CORYZA ABC Gel(Inactivated Aluminium Hydrooxide suspension Vaccine for the immunization of chickens against infectious Coryza.

Composition: Active substances:Inactivated antigens:Avibacterium paragallinarum serotypeA……min. 7 log 10 CFU* before inactivation

Avibacterium paragallinarum serotype B…… min. 7 log 10 CFU* before inactivation

Avibacterium paragallinarum serotype C…… min. 7 log 10 CFU* before inactivation.

*CFU – colony forming unitPharmacological group:

Form 5-A

Dy No. 1495 R&I DRAP dated 05-5-2016

Fee deposited: Rs.100000/- dated 02-5-2016

Packs: One dose of 0.5ml

GMP Certificate No. CG-HU/09V/2014

DML No. MA-HU/04V/2009/M1. Dated 04-11-2014 Hungary

Legalized valid Free sale certificate along with GMP/ CoPP is required.

As the firm has provided valid legalized FSC ((02.2/3442-3/ 2016 dated 10-06-2016) and GMP certificate (02.2/3442-5/ 2016 dated 10-06-2016) and Registration Board considerd the documents and approved the product as per Import Policy for finised drugs.


Biologicals – Avian inactivate vaccine.

Route of administration: one dose of 0.5ml injected subcutaneously or intramuscularly

Uses: ITA CORYZA ABC Gel is recommended for vaccinatin f breeder and laying type of chicken flocks against infectious Coryza caused by Avibacterium paragallinarum infection in order to reduce the clinical signs and lesions of diseases.

12. M/s Marush Limited, Lahore

CEVA PHYLAXIA, Veterinary Biological, Co. Ltd 110 7 budapest Szallas u 5 Hungary.

CEVAC Transmune

(Live freeze dried complex vaccine, (winterfield 2512 G-61 strain IBD antibidoes)

Each dose contains:Avian infectious bursal disease virus strain winterfield 2512,

Form 5-A

Dy No. 271 R&I DRAP dated 13.5.16

Fee deposited: Rs.100000/- dated 11-5-2016

Packs: 2000. 4000, 8000 doses.

Legalized FSC No.02.2/729-21/2016 dated 08-2-2016

Legalized GMP No.02.2/729-21/2016 dated 08-2-2016.

Approved as per Import Policy for finished drugs and as per valid legalized COPP.


G-61……min 0.1 CID 50

Immunization of healthy chicjens against IBD

Route of adm: SC


Case No.03: Cases of Veterinary Biological Vaccines / Drugs for Local Manufacturing.

S.#. Company name and name of manufacturer

Brand name /Drug Composition

Date of application/ Fee status/ packs

International availability/ Me too status

Remarks Decision

1. M/s Grand Pharma (Pvt) Ltd, Rawat, Islamabad(Local Manufacturer)

GPVAC ND (A) InjectionNewcastle Disease VaccineEach dose of 0.30 ml contains:Inactivated Newcastle Disease Virus….Inducing≥4.5 log2 HI uits

Uses: For the precention of Newcastle Disease in poultry for facster production of antibodies

Shelflife: one year

Form-5

Dy No. 567 ADC(BD) dated 23-5-2016

Fee deposited Rs.20000/- dated 20-5-2016

Price : Decontrolled

Packs 250ml, 300ml,500ml,600ml

Local manufacturing of veterinary vaccine. In the 254th RB Meeting on the similar case the Board decided for product specific inspection by experts focusing on processs, strain status, safety and potency data.

Deferred for products specification inspection by following experts:

a. Dr. Muhammad Arshad, Member Registration Board

b. DDG Biological), DRAP

c. Area FID, DRAP

2. M/s Grand Pharma (Pvt) Ltd, Rawat,

GPVAC H-9 Shield Injection

Form-5

Dy No.562

Local manufacturing of veterinary

Deferred for products specification


Islamabad(Local Manufacturer)

Avian Influenza H9 cloned vaccineEach ml (1000 doses0 contains;Live rHVT-H9 virus…..3x106 plaque-forming units (pfu)Dosage: 3x103 fpu per bird

Shelf life: Two years

Uses: For the prevention against avian influenza virus serotype H9 and Marek’s disease virus serotype-3 in broilers.

ADC (BD) dated 23-5-2016


Price: Decontrolled

Packs, 1000,2000,4000,5000 doses

vaccine. In the 254th RB Meeting on the similar case the Board decided for product specific inspection by experts focusing on processs, strain status, safety and potency data.

inspection by following experts:


b. DDG Biological)

c. Area FID, DRAP


GPVAC ND+IB+H9 InjectionCombined Newcastle disease, Infectious bronchitis and avian influenza H9 vaccineEach dose of 0.30ml contains:Inactivated Newcastle disease virus….inducing5 log2 HI units/dose

Infectious bronchitis virus (Mass strain)….inducing5 log2 HI units/dose

Form-5

Dy No. 563 ADC (BD) dated 23-5-2016


Price : Decontrolled

Packs 250ml, 300ml,500ml, 600ml




b. DDG Biological)

c. Area FID, DRAP


Inactivated Avian Influenza virus H9….inducing5 log2 HI units/dose.



GPVAC ND-Kaseef Injection New castle Disease VaccineEach dose of 0.20ml contains:Inactivated Newcastle Disease Virus…Inducing4.5 log2

HI units


Form – 5Dy No. 564 ADC (BD) dated 23-5-2016


Price: Decontrolled





b. DDG Biological)

c. Area FID, DRAP


GPVAC POLY-FLU InjectionAvian Influenza polyvalent vaccineEach dose of 0.30ml contains:

Inactivated Avian Influenza type H5….Inducing5 log2 HI units/dose

Inactivated Avian Influenza type H7….inducing5 log2 HI units/dose

Form – 5



Price: Decontrolled

Packs 250ml,




b. DDG Biological)

c. Area


Inactivated Avian Influenza virus H9….inducing5 log2 HI units/dose.

Shelf Life: Two years

300ml,500ml,600ml

FID, DRAP


GPVAC Hydro-TC Plus InjectionBivalent HPS-IBH vaccineEach 0.30 ml dose contains:

Inactivated Avian Adenovirus serotype-4….7 log10 EID50/dose

Inactivated Avian Adenovirus serotype-8….7 log10 EID50/dose.


Form – 5



Price: Decontrolled





b. DDG Biological)

c. Area FID, DRAP


GPVAC MG-Bacterin InjectionMycoplasma gallisepticum vaccine Each ml contains:Mycoplasma gallisepticum……5 x 107 CFU/ml


Uses: For the prevention of mycoplasma gallisepticmum in

Form – 5



Price: Decontrolled

Packs 250ml,




b. DDG Biological)

c. Area FID,


poultry. 300ml,500ml,600ml

DRAP


GPVAC FLU 7+9 (A) InjectionAvian Influenza virus H7+N9 Aqueous vaccineEach dose of 0.30ml contains:Inactivated Avian Inafluenza virus H7…Inducing4.5 log2

HI units

Inactivated Avian Inafluenza virus H9…Inducing4.5 log2

HI units

Shelf life: One year

Form – 5



Price: Decontrolled





b. DDG Biological)

c. Area FID, DRAP

9. M/s SANNA Laboratories, Faisalabad(Local Manufacturer)

NIAB (H.S. VACCINE) InjectableFormaline inactivated Pasturella muoltocida oil adjuvanted vaccineEach dose contains: ….Inactivated oil emulsified Pasturella multocida

Proposed route: Subcutanous Injection

Uses: For animals

Form – 5



Price: Decontrolled


PSI is required by the panel of experts.



b. DDG Biological)

c. Area FID, DRAP


to protect against Heamorrhagic Septicemia

Shelf life: 02 years10. M/s SANNA

Laboratories, Faisalabad(Local Manufacturer

PROMASInjectable

Each ml contains an minimum of 6 x 109 m.o of:Staphylococcus aureus, Streptococcus agalactiae, Escherichia coli and Arcanobacterium pyogenes oil adjuvancted vaccine.

Uses: For prevention of mastitis in cattle buffalo, sheep, goat and camel.


Form -5


Dosage: 5ml

Price - Decontrolled

PSI is required by the panel of experts.



b. DDG Biological)

c. Area FID, DRAP

11. M/s SANNA Laboratories, Faisalabad(Local Manufacturer

ENTOMIAVAC (Enterotoxemia Vaccine)

Formaline inactivated clostridium perfringeens oil adjuvanted vaccine

Each dose contains:

Form -5

Dy No. 472 R&I, DRAP dated 22-3-2016


Dosage: 2ml




Inactivated Oil Emulsified Clostridium perfringens… 1 x 109

Shelf Life: One (01) Year

Uses: For Sheep/ Goat to protect atainst Enterotixemia

Price – Decontrolled

Packs: 15ml, 30ml , 300ml, 600ml.

b. DDG Biological)

c. Area FID, DRAP


BQ-VAC (Black Quarter Vaccine)

Formaline Inactivated Clastridium chavoei oil adjuvanted Vaccine

Each dose contains: Inactivated Oil Emulsified Clostridium Chavoei.. 1 x 109

Shelf Life: One Year

Uses: For large animals to protect against Black Quarter

Form -5




Packs: 30ml, 90ml , 300ml, 600ml.



b. DDG Biological)

c. Area FID, DRAP

13. M/s SANNA Laboratories, Faisalabad

APTHOVAC (Foot and Mouth disease Vaccine)

Form -5

Dy No. 475

Deferred for products specification inspection by


(Local Manufacturer Formaline

inactivate Aphthovirus oil adjvanted Vaccine

Each dose contains: Inactivated Oil Emulsified Aphthovirus


R&I, DRAP dated 22-3-2016



Packs: 25ml, 50ml , 100ml, 200ml.

following experts:


b. DDG Biological)

c. Area FID, DRAP


SANTHRAX (Anthrax Disease Vaccine)

Formaline inactivated bacillus anthracis oil adjuvanted Vaccine

Each dose contains: Inactivated Oil Emulsified Bacillus anthracis 5 x109


Uses: For large animal to protect against anthrax

Form -5




Packs: 25ml, 1250ml , 300ml, 900ml.



b. DDG Biological)

c. Area FID, DRAP

15. M/s SANNA Laboratories, Faisalabad

GALLIPRO ND+H9 (ND & A1 H9 Disease

Form -5

Dy No. 474

Deferred for products specification inspection by


(Local Manufacturer

Vaccine)

Formaline inactivated New castle disease virus lasota & Influenza A Virus subtype H9 oil

Each dose contains:Inactivated Oil Emulsified New castle disease virus lasota Influenza A Virus subtype H9


Uses: For Poultry Birds to protect against New castle disease and sub strain H9 of Avian Influenza disease

R&I, DRAP dated 22-3-2016



Packs: 150ml, , 300ml, 600ml.

following experts:

a. Dr. Muhammad Arshad, Member Registration Board.

b. DDG Biological).

c. Area FID, DRAP

Case No.04: Local Manfacturing Of (Biological Drugs) M/S Macter International, Karachi

a. Clariclot (Recombinant streptokinase) 1.5MIU Vial of M/S Macter International Karachi

S.No. Documents and data required as per 246th

meeting

Documents and data submitted by M/s Macter International Karachi

Remarks

1. Legalized GMP certificate of biological drug as an evidence that the manufacturer is an authorized manufacturer of that particular biological

Firm has submitted the legalized GMP certificate NO. 3753/M3b/2013 dated 20-5-2013 valid upto 2years from date of issuance of Manufactured by M/s Shasun Pharmaceuticals Limited

Valid legalized GMP is required.


drug in its country of origin. 33&34, Shasun Road, Periyakalapet, Puducherry – 605014, Mfg at Vijayapuri North Nagarjunasagar Nalagonda District India

2. Legalized COPP No. 1919-AB(M3A) TS / 2014 valid upto 19-5-2015 for LIFOKINASE 1.5MIU (STREPTOKINASE INJECTION IP)Manufactured by M/s Shasun Pharmaceuticals Limited 33&34, Shasun Road, Periyakalapet, Puducherry – 605014, Mfg at Vijayapuri North Nagarjunasagar Nalagonda District India

3. Structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator)

Not provided Structural similarity data is required

4. Manufacturer to manufacture the finished biological product for trial studies

Not provided

5. Bio-comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing data, gel electrophoresis, Western-Blot and other analytical techniques) and stability studies of finished biological product

Not provided Bio-comparability study data is required.

6. Others Specification of streptokinase bulk solution provided as under: Description

No local data available. Directions from RB is solicited.


Particular Matter Identification test PH Bacterial endotoxin Assay (Activated by bioassay SterilityStability Study report streptokinase bulk solution providedFinished product specifications submitted by M/s Macter International, Karahci are as under:

Description, Identification, PH, Steptodoranse, Streptolysin, Loss on drying, Bacterial Endotoxin, Assay (Acitivity by Bioassay), Sterility, Clarity of solution, Particulate Matter, Extractable volume and Uniformity of weight.

Finished product stability submitted by M/s Shasun Pharmaceuticals India.

The submitted data needs to be evaluated in the light of 246 th meeting of RB by panel of experts for geniuness and accuracy.

b. Redimab (Rituximab) 100mg/10ml Vial of M/s Macter International, Karachi

Sr. No

Documents and data required as per 246th

meeting


Remarks

1 Legalized GMP certificate of biological drug as an evidence that the manufacturer is an authorized manufacturer of that particular biological

Legalized GMP Certificate No. CN20110019 DATED 09-10-2011 valid until 08-10-2016 M/s Shanghai CP Guojian Pharmaceutical co., Ltd. China.


drug in its country of origin.

2 Structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator)

Charactrization of Primanry and secrondary structure of redimab and its comparability analysis with innovator retuximab sold under brand name of Rituxan by M/s Shanghai CP Guojian Pharmaceutical co., Ltd. China following methods:

N-terminal amino acid sequenced analysis,

C-terminal Lys truncation by mass peptide maping by sequence coverage.

Molecule weight by reducing SDS PAGE.

MALDI-TOF Mass spectrum performed the test results demonstrate that the main components of basically identical, and the molecular weight of relative to each other

Peptide Mapping by RP-HPLCwhich demosntrates that our products are homogeneioujs and stable.

Comparison of Methionine Oxidation for Anti-CD20 innovator.

Biological Charatarization was done by biocactivity determination and affinity comparison by immumofluorescence method.

Inpurities by SEC-HPLC, SDS-PAGE

3 Manufacturer to manufacture

the finished biological product for trial studies

4 Bio-comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity

Comparitive analysis of finished drug (Redimab) with Ristova of Roche:Identity by SDS Page


with support of iso-electro focusing data, gel electrophoresis, Western-Blot and other analytical techniques) and stability studies of finished biological product

Purity:SDS Page (Silver staining)Gel Filteration HPLCProtein content by UV (280nm)Biological activityGeneral safety tests :BET and sterlity

5 Others Certificateof analyisis of Rituximab bulk is submitted. Stability data of finished product (accelerated and real time ) is provided.Clinical Data has also been submitted.


c. Redimab (Rituximab) 500mg/50ml Vial of M/s Macter International, Karachi

Sr. No


meeting


Remarks

1 Legalized GMP certificate of biological drug as an evidence that the manufacturer is an authorized manufacturer of that particular biological drug in its country of origin.

Copy of GMP Certificate No. CN20110019 DATED 09-10-2011 valid until 08-10-2016 sumbitted.


Charactrization of Primanry and secrondary structure of redimab and its comparability analysis with innovator retuximab sold under brand name of Rituxan by M/s Shanghai CP Guojian Pharmaceutical co., Ltd. China following methods: N-terminal amino acid

sequenced analysis, C-terminal Lys truncation by

mass peptide maping by


sequence coverage. Molecule weight by reducing

SDS PAGE. MALDI-TOF Mass spectrum

performed the test results demonstrate that the main components of basically identical, and the molecular weight of relative to each other

Peptide Mapping by RP-HPLCwhich demosntrates that our products are homogeneioujs and stable.

Comparison of Methionine Oxidation for Anti-CD20 innovator.



3 Manufacturer to manufacture the finished biological product for trial studies

4 Bio-comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing data, gel electrophoresis, Western-Blot and other analytical techniques) and stability studies of finished biological product

Comparitive analysis of finished drug (Redimab) with Ristova of Roche:Identity by SDS PagePurity:SDS Page (Silver staining)Gel Filteration HPLCProtein content by UV (280nm)Biological activityGeneral safety tests :BET and sterlity

5 Others Certificateof analyisis of Rituximab bulk is submitted.Stability data of finished product (accelerated and real time) is provided.Clinical Data has also been submitted.



d. EPOCAN Injection (Epoetin alpha 2000IU/ml., 4000IU/ml and 10000IU/ml) Vial of M/s Macter International, Karachi

Sr. No


meeting


Remarks


Legalized GMP Certificate No. CN20140140 date of issuance 17-3-2014 valid upto 16-03-2019 M/s Shandong Kexing Bio – Products co., Ltd. Tangwangshan Road, Mingshui Development Zone, Zhangqiu, Shandong, China submitted.

GMP submitted reflects that manufacturer is authorize to manufacturer Recombinant Human Erythropoietin injection.

2 Legalized Free Sale Certificate No. 2015-157 date of issuance 16-11-2015 valid for two year for date of issuance for Erythropoietin injection submitted. Legalized COPP No. WHO. CPP-CERT-ZQ-151116 date of issuance 16-11-2015


Not provided Only comparative studies conducted locally is submitted


5 Bio-comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing data, gel electrophoresis, Western-Blot and other analytical techniques) and stability

Comparative analysis of Recombinant Human Erythropoietin Vs RMP Recormon Roche is submitted and following test are carried out by M/s Macter International, Karachi SDS-PAGE (Silver staining) Isoelectric focusing Purity( By Gel filtration


studies of finished biological product

chromatography) Sialic Acid (by Resorcinol

Method) Protein content (By ELISA)

Comparitive analysis of Finished product VS BRP Erythropoetin Alfa EDQM is also submitted and following test are carried out: Identity by ELISA, Potency by Elisa, Total Protein content (By Lowry Assay), General Safety Test (By Bacterial endotixin test by gel Clot Method (LAL Test), Sterility Test by membrane filtration method.

6 Others Specification of ready to filled bulk of M/s Shandong Kexing bioproducts Co., Ltd, ChinaIdentification test, Physical tests (Appearance Visible particles), Chemical tests (pH, Content of sodium ion content of citrate ion content of protein Osmolality, Activity tests (Activity in vitro , Activity in vivo), Sterility and BET , Abnormal toxicity test.

Finished products specification of M/s Macter International Karachi as under:Physical Appearance, ParticulateMater, Extractable volume, pH, Osmaolality, Immuno-identification, Potency, Content of Protein, BET, Sterility, Abnormal Toxicity.

The firm has also submitted accelerated and real time stability studies



e. T-Mab (Trastuzumab) 150mg Vial of M/s Macter International, Karachi

Sr. No


meeting


Remarks


Legalized GMP Certificate No. CN20110019 dated 09-10-2011 valid until 08-10-2016 M/s Shanghai CP Guojian Pharmaceutical co., Ltd. China.


Charactrization of Primanry and secondary structure of anti-HER2 rh.MAb and its comparability analysis with innovator Herceptin by M/s Shanghai CP Guojian Pharmaceutical co., Ltd. China following methods: The pimary structure of anti-

HER2 rhMAb. Similarity in secondary sturucture by circular dichroism (CD) and Spectra.

Similarity in IEF profile. Similarity in molecular weight

by reducing SDS-PAGE. MALDI-TOF Mass spectrum

performed the test results demonstrate that the main components of basically identical, and the molecular weight of relative to each other.

Peptide Mapping by RP-HPLC which demosntrates that our products are homogeneioujs and stable.

N-Glycosylation Analtysis. Similarity in Biological

Activities and Immunological Properties

Biological Charatarization was done by biocactivity determination and affinity comparison by


immumofluorescence method. Inpurities by SEC-HPLC, SDS-

PAGE3 Manufacturer to manufacture



Biocomparability of finished drug the firm has submitted following data are as under:

Comparative Analysis of Locally Manufactured Drug Product of T-Mab 150 mg with Reference Medicinal Product Harceptin, Materials, Indentificatin (BySDS-PAGE), Purity (By SDS-PAGE), Reiative Potency (By ELISA), General Safety Tests (By Bacterial Endotoxin Test) (By Sterility Test) (By Abnormal Toxicity Test) (By Abnormal Toxicity Test). Stability Studies of Locally Manufactured Drug Product of T-Mab 15mg with Reference Medicinal Product Harceptin. Real Time stability studies, Accelerated stability studies

5 Others Animal Toxicology study The firm submitted data are as under:1. Pharmacology(Primary pharmacology, Secondary Pharmacology, Safety Pharmacology, Pharmacodynamic drug interactions).2. Pharmacokinatics(Absorption, distribution, Metabolism, Excretion, Pharmacokinetics Drug Interaction)3. Single-Dose Toxicity(Acute Single-Dose toxicity for intravenous injection anti-HER2 rh MAB of CPGJ into mice)4. Repeat-Dose toxicity(Repeat-Dose toxicity for intravenous injection anti-HER2 rh


MAB of CPGJ into rhesus)5. Genotoxicity(Genotoxicity of –HER2 rh MAB of CPGJ)6. Hepolytic Study(Hemolytic Study of –HER2 rh MAB of CPGJ)


f. T-Mab (Trastuzumab) 440mg Vial of M/s Macter International, Karachi

Sr. No


meeting


Remarks


Legalized GMP Certificate No. CN20110019 dated 09-10-2011 valid until 08-10-2016 M/s Shanghai CP Guojian Pharmaceutical co., Ltd. China

The application of the firm is consider in 257th meeting of RB wherein it was deferred for evaluation by the division.


Charactrization of Primanry and secondary structure of anti-HER2 rh.MAb and its comparability analysis with innovator Herceptin by M/s Shanghai CP Guojian Pharmaceutical co., Ltd. China following methods: The pimary structure of anti-

HER2 rhMAb. Similarity in secondary sturucture by circular dichroism (CD) and Spectra.

Similarity in IEF profile. Similarity in molecular weight

by reducing SDS-PAGE. MALDI-TOF Mass spectrum

performed the test results demonstrate that the main components of basically identical, and the molecular weight of relative to each other.

Peptide Mapping by RP-HPLC which demosntrates that our


products are homogeneioujs and stable.

N-Glycosylation Analtysis. Similarity in Biological

Activities and Immunological Properties





Biocomparability of finished drug the firm has submitted following data are as under:

Comparative Analysis of Locally Manufactured Drug Product of T-Mab 15mg WITH Reference Medicinal Product Harceptin, Materials, Indentificatin (BySDS-PAGE), Purity (By SDS-PAGE), Reiative Potency (By ELISA), General Safety Tests (By Bacterial Endotoxin Test) (By Sterility Test) (By Abnormal Toxicity Test) (By Abnormal Toxicity Test). Stability Studies of Locally Manufactured Drug Product of T-Mab 15mg with Reference Medicinal Product Harceptin. Real Time stability studies, Accelerated stability studies

5 Others Animal Toxicology study The firm submitted data are as under:

1. Pharmacology(Primary pharmacology, Secondary Pharmacology, Safety


Pharmacology, Pharmacodynamic drug interactions).2. Pharmacokinatics(Absorption, distribution, Metabolism, Excretion, Pharmacokinetics Drug Interaction)3. Single-Dose Toxicity(Acute Single-Dose toxicity for intravenous injection anti-HER2 rh MAB of CPGJ into mice)4. Repeat-Dose toxicity(Repeat-Dose toxicity for intravenous injection anti-HER2 rh MAB of CPGJ into rhesus)5. Genotoxicity(Genotoxicity of –HER2 rh MAB of CPGJ)6. Hepolytic Study(Hemolytic Study of –HER2 rh MAB of CPGJ)


g. Macgrastim (Filgrastim (rhGCSF) 300mcg/ 1.2 ml) vial.

Sr. No


meeting


Remarks


Legalized CoPP No: CN20130269 dated 30.09.2013 valid upto 29.09.2018 of M/s Hangzhou Jiuyuan Gene Engeineering Co., Ltd, China indication that the manufacturer has approval to manufacture the rhGCSF injection

2 Structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product

Physicichemical and biosililarity analysis of rhGSCF with Filgratim produced by Kirin Brewery Co., Japan:rhGSCF Formula/ chemical structure.


(innovator) Molecular weight:SDS reducing Page HPLC

Purity:Gel electrophoresisIsoelecric focusingRP HPLCSEC HPLCCapillary electrophoresis

Assay for chemical structure:Sequencung of rDNAUV spectrumComposition of amino acidsPepetide mappingN- terminal sequencing

Immunology: Identification by wetstern blotELISA

Bilogical activity.3 Manufacturer to manufacture



Comparative Analysis of Locally Manufactured Product Macgrastim Liquid Solution for Injection (300 mcg/ 1.2 ml ) VS Neupogen (Innovator):

Immunoidentification by western blot

Purity by SDS Page Purity by gel filteration Potency protein by

Bradford assay Bilogical activity by cell

proliferation assay General safety tests : BET

and sterlity5 Others Certificate of analysis of bulk

material to be supplied is sunmitted.Stability data of finished product (accelerated and real time is provided)Clincal data submitted.



Local manfacturing of (biological drugs) M/s Sami Pharmaceuticals (Pvt) Limited, Karachi.

h. PEGINTOR-2a Recombinant Human Peginterfereon Alfa-2a, (180mcg) 0.5ml Pre-filled syringe of M/s SAMI Pharmaceutical s(Pvt Limited Karachi.

Sr. No


meeting

Documents and data submitted by M/s SAMI Pharmaceutical s(Pvt Limited Karachi

Remarks


Legalized GMP Certificate No. 20132014-001810-14 dated 30-1-2015 of M/s LABORATORIO PABLO CASSARA S.R.L Republica Argentina.

Firm will import the bulk interferon alfa 2a and pegylation will be done at manufacturing facilty of M/s Sami Pharma Karachi


Following details are provided for the bulk concentrate against the standard by the M/s LABORATORIO PABLO CASSARA S.R.L Republica Argentina.

Appearance PH Identification:

a. Assay: Protein content, biological activity

b. Isoelectic focusingc. Test for impurities fo

molecular masses differing from that of interferon alfa 2 (SDS Page reducing condition)

d. Peptide mappinge. impurities fo molecular

masses differing from that of interferon alfa 2 (SDS Page reducing and non reducing condition)

f. related proteins by HPLC

g. BET3 Manufacturer to manufacture

the finished biological


product for trial studies4 Bio-comparability studies

including identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing data, gel electrophoresis, Western-Blot and other analytical techniques) and stability studies of finished biological product

Accelerated stability data 6 months of 3 batches submitted and biocomparibility studies witb pepgasys are provided with fillowing parameters:

Appearance Identification by SDS Page Proetein content by optical

density Impurities BET Sterility

5 Others Clinical data provided.

Product specific inspectin for the facility is required. The submitted data needs to be evaluated in the light of 246th meeting of RB by panel of experts for geniuness and accuracy.

Local Manfacturing of (Biological Drugs) M/S BF Biosciences, Lahore

i. Noxane (Prefilled syringe) (Enoxaprin sodium 20mg/0.2ml, 40mg/0.4ml, 60mg/0.6ml and 80mg/0.8ml) of M/S BF biosciences, Lahre


meeting

Documents and data submitted Remarks

1. Legalized GMP certificate of biological drug as an evidence that the manufacturer is an authorized manufacturer of that particular biological drug in its country of origin.

Firm has submitted the Copy of GMP Certificate No. SD 20140225 vlidupto 26-5-2019 of M/s Dongying Tiandong Phamraceutical Co., Ltd No. 1236, Noner Road, dongying City China, for Enoxaparin Sodium

The Director Technical has inform that the bulk will be imported from the Uroguay. The API in the said bulk will be used from manufacturer at China.

2. Legalized COPP No. 156026 dated 09-4-2014 for Noxprin Sodium manufacurerd by Laboratorios Clausen S.a.- Bulevar Artigas 3896 – Montevideo, Uruguay.

3. Structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product

Eludication of structure Following details are provided by M/s Dongying Tiandong Phamraceutical Co., Ltd China. Absorption


(innovator) Spectrophotometry , The infrared spectra of sample is consitent with that of the CRS

Absorption Spectrophotometry, UV spectra is consitent with that of the CRS

NMR Spectrophotometry ( 1H –NMR spectrum and 13C-NMR cpectrum of thesample is consistent with those of the CRS

Imputities (Potential Imopurities Originating from the route of synthesis), (Potential Impurities Orininating from the raw material s and from the impurities in the raw materials), (Protein and nucleotide), Dermatan sulfate) (Heavy metals) (Bacterial endotoxins), (Limit of Impurities and Analytical Methods applied by the API’s manufacturer), Protein and nucleotide heavy metals and bacterial endotoxins), Dermatan sulphate), (The Potential Toxicity of Impurities), (Residual solvents)

4. Manufacturer to manufacture the finished biological product for trial studies

Not provided


Not provided


6. Others


j. Eritrogen (Erythropoetin) 2000IU, 4000IU and 10000IU PreFilled Syringe of M/S BF Biosciences, Lahre


meeting

Documents and data submitted Remarks

1. Legalized GMP certificate of biological drug as an evidence that the manufacturer is an authorized manufacturer of that particular biological drug in its country of origin.

Firm has submitted the Legialized GMP certificate No. 20132021-000 033-15 dated 08-6-2015 of M/s ZELLTEK S.A, Ruta Nacional No 168 S/N, Pasaje “EI Pozo’, Parque Tecologico Litoral , of the Province of Santa Fe, of the Argentine Republic.

2. Structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator)

Under Eludication of structure of API, comparative analysis with EPO Standard BPR is provided by M/s ZELLTEK S.A, Argentine Republic.

Glycoform analysis Primary Structure Secondary Structure Tertiary structure Disulfide bridges N-terminal sequence Sialic Acid Content Native N-glycans profile Neutra N-glycans profile O-glyscosilatin site occupation Content of dimmers and

related substances of high molecular weight


Invivo biological activity.3. Manufacturer to

manufacture the finished biological product for trial studies

Not provided


Not provided

5. Others


Decision: Regiatration Board deliberated and deferred these applications that manufacturing and quality control of biological products require specialized facilities and approval from the Licensing Division, DRAP. The Baord dicussed that theses manufacturing units have already been granted registrations of various biological products for local manufacturing (mostly therapeutic proteins). As theses firms have applied for registration for local manufacturing of various biological products including rDNA products, Theraputic protein, Monocronial antibodies, Vaccines (Live, Attentuated, rDNA vaccines, so the Board decided to have opinion of licensing division DRAP regarding approved manufacturing facilities (categories of biological products) of these firms and status of already registerd biological drugs from these firms.

Case No.05: As per decision of 258th meeting of RB. All the cases of import of Heparin are placed below for a joint collective decision as per recommendation of WHO.

a. Deferred case of M/s Ghazali Brothers Karachi in 258th meeting of Registration Board

Following product of M/s Ghazali brothers Karachi are deferred by the Registration

Board 254th meeting for completion of applications, remaining fee, CoPP status, information regarding

availability in country of origin and deliberations regarding requirement for bio-similarity of products.


Sr. No



Type of Form


Fee submitted

Pack size/ Demanded Price



Remarks

1. Ghazali Brothers,Karachi.

KotraPharma(M) SdnBhd, Jalan TTC 12ChengIndustrialEstate,Melaka,Malaysia.

VAXCELL HeparinSodium Injection5000 IU/ml

Each 5ml contains:-Heparin Sodium…..25000IU

Anticoagulant

Shelf life: three years

Form-5A

Dy No. 43 dated 03-03-2011

15000/- dated 03-03-20113500/- dated 09-10-201250000/- dated 16-06-2015

Rs.540/ 5ml

Legalized CoPPCertificate No. 0346/ 2015 dated 10-03-2015

Me too

Product is available in country of origin and full fee as required is submitted. Firm has submitted the clinical data/ biosimilarity data

Decision: Registration board deliberated that WHO exempts Heparins and Enoxaprin from the condition of biosimilarity. Keeping in view this position, the Board approved the above products for registration as per Import Policy for Finished Drugs.

b. Deferred case of M/s Shamco Traders (Pvt) Limited, Lahore in 258th meeting of Registration Board.

S.#. Company Name and Name of Manufacturer

Brand Name and Composition

Date of application/Fee status

Documentary details

Remarks

13. M/s Shamco Traders (Pvt) Limited, Lahore

POLIPARIN 25000 IU/ 5ml IV/ SC

Form-5A

Dy No. 1241

CoPP No 2014/ 335 dated 22-


License Holder:PolifarmaIlacSanayiVeTicaretAS TozkoparanMah. HaldunTaner&SkAlparsalanMerkezi Istanbul

Manufacturer:MefarIlac San AS RamazanogluMah. Ensar Cad. No: 20 34906 KurtkoyPendik Istanbul.

Injectable vial

Each 5ml vial contains:Heparin sodium……25000IU

dated 12-10-15

Rs 100000 dated 12-10-15

625/ vial

07-2014

Copy of GMP dated 15-08-2013 valid up to 12-2015

Decision: Registration board deliberated that WHO exempts Heparins and Enoxaprin from the condition of biosimilarity. Keeping in view this position, the Board approved the above products for registration as per Import Policy for Finished Drugs.

c. Registration of Import Product Namely Medirin Heparin Sodium 5000IU/ml & 25000IU/ml M/s Medi Mark Pharmaceutical Lahore and Hepacin Injection 25000 iu/5ml, Bajwal Sons, Lahore

M/s Medi Mark Lahore had applied for registration of Medirin Injection (Heparin) 25000

IU/5ML and Medirin Injection (Heparin) 5000IU/ml and M/s Bajwa sons, Lahore had applied for

registration of Hepacin Injection 25000 iu/5ml. Both companies have same manufacturer abroad. The

case is being placed 254th meeting before the Registration Board. The decision of 254 th Registration Board

meeting as follows:

“Registration Board deferred the case. M/s Medi Mark and Bajwa sons has same source. Firm will be

advised to provide latest Whole Sale Agency Certificate from manufacturer. Complete information for

CoPP is also required”.

Later on the M/s Medi Mark has provided copy of sole agency agreement with its Chinese

manufacturer. The document is not on the company letter head nor has been notarized. The Medi Mark

provided also copy of CoPP. The case was placed on agenda of 256 th meeting of Registration Board.

Documentary details as below:


S.#. Company Name and Name of Manufacturer

Name of Product/ Composition

Date of application / Fee status

Remarks

1. Medi Mark Pharma, Lahore.

Furen Pharmaceutical Group Co., Ltd, Address: 1Xuan Wu Economic Developing -area, Luyi Country, Henan China.Address 2:No.1 Tongyuan road, Industrial centralized area, LuYi County, Henan Province China

MEDIRIN INJECTION 5000IU/ML

Composition

(Heparin Sodium Injection 5000 IU/ml )

Anti Coagulant

Date of Application23-05-2013

Fee depositedRs.100000/-

Balance feeNil

Me too

2. Medi Mark Pharma, Lahore.

Furen Pharmaceutical Group Co., Ltd, Address: 1Xuan Wu Economic Developing -area, Luyi Country, Henan China.Address 2:No.1 Tongyuan road, Industrial centralized area, LuYi County, Henan Province China

MEDIRIN INJECTION 25000 IU/5ML

Composition(Heparin Sodium 25000IU/5ml)

Anti Coagulant

Date of Application23-05-2013

Fee depositedRs.100000/-

Balance feeNil

Me too

Registration Board decided as follows:

“Registration board considered above applications of Medi Mark Pharma, Lahore and

advised to provide legalized CoPPs and notarized sole agency agreement.”


M/s Medi Mark has now provided the legalized CoPP (original) and notarized sole agency

agreement as per directions of the Registration Board.

Decision: Registration Board considered the request of M/s Medi Mark Lahore and referred the applications for expert opinion of the following:

i. Brig. (R) Muzamil Hussain Najmi, Member Registration Board.ii. Brig. Abid Azhar, AFIP, Rawalpindi.iii. Dr. Masud-ur-Rehman, DDG DRAP, Islamabad.

“M/s Medi Mark is advised to provide the notarized sole agency agreement from country of origin. As two manufacturing sites are mentioned on CoPP submitted by M/s Medi Mark Lahore, therefore clarification will be obtained from firm about manufacturing site. The application of M/s Bajwa Sons Lahore will be considered after aforementioned clarification”.

M/s Medi Mark has submitted Legalized and Notarized Sole Agency Agreement and Notarized

cancellation letter from Furen Pharmaceutical Group Co., Ltd. China as per directions of the Registration

Board in 257th meeting mentioned above.

Decision: Registration Board deliberated that WHO exempts Heparins and Enoxaprin from the condition of biosimilarity. Keeping in view this position, the Board approved the above products for registration as per Import Policy for Finished Drugs.


d. Grant of Registration Human Imported product Enclex 40 (Enoxaparin Sodium Injection

IP 40MG/0.4ml) M/s AJ Mirza Pharma (Pvt) Ltd, Karachi.

M/s AJ Mirza Pharma (Pvt) Ltd Karachi has applied for grant of registration HumanImported product Enclex 40 (Enoxaparin Sodium Injection IP 40MG/0.4ml). Product details is as under:

1. M/s AJ Mirza Pharma (Pvt) Ltd, Karachi

Cipla Ltd 289, Bellasis Road, Mumbai Central, Mumbai 400 008 India

Enclex 40

(Enoxaparin sodium Injection IP 40mg/0.4ml

Each prefilled syringe contains:

Enoxaparin Sodium IP…….40mg.

Equivalent to 4000 IU anti-Xa activity.

Water for Injection Ip…….q.s.

Pharmacological group: Antithrombotic agent, low molecular weight Heparin.

Route of Adminstration: Intara Venous & Sub cutaneous

Form 5-A

Dy. No. 29 R&I DRAP dated 10-10-2014

Fee deposited: Rs. 100000/- dated 10-10-2014

Packs: 0.4ml PFS

Legalized COPP No. 831/MFG/WHO-GMP/DFDA/2012/1742 valid up to 14-6-2014 from India

Product License No. 704 dated 08-4-2005

DML No. 831/MFG/CERT/DFDA/12/5863 dated 06-2-2012



2. M/s AJ Mirza Pharma (Pvt) Ltd, Karachi

Enclex 60

(Enoxaparin sodium Injection IP 60mg/0.6ml

Form 5-A

Dy. No. 28 R&I

Legalized COPP No. 831/MFG/WHO GMP/DFDA/201

Valid and legalized COPP/ FSC along with


Cipla Ltd 289, Bellasis Road, Mumbai Central, Mumbai 400 008 India

Each prefilled syringe contains:

Enoxaparin Sodium IP…….60mg.

Equivalent to 6000 IU anti-Xa activity.

Water for Injection Ip…….q.s.

Pharmacological group: Antithrombotic agent, low molecular weight Heparin.

Route of Adminstration: Intara Venous & Sub cutaneous.

DRAP dated 10-10-2014

Fee deposited: Rs. 100000/- dated 10-10-2014.

Packs: 0.6ml PFS

2/1734 valid up to 14-6-2014 from India


DML No. 831/MFG/CERT/DFDA/12/5863 dated 06-2-2012

GMP Certificate need to be submitted as per above decision of 255th meeting.



e. Grant of Registration Human Imported product Heparodic 5000 (Heparin sodium) M/s AA Pharma, Karachi.

M/s AA Pharma, Karachi has applied for grant of registration Human Imported product

Heparodic 5000 (Heparin sodium) Product details is as under:

S. No



Dy No & Date of application/ Fee status/ Pack size/ demanded Price


Me too status

Remarks


1 M/s AA Pharma, Karachi

Caspian tamin PhamaceuticalCo. First Entrance, Rasht Industrial Zone, P.O. Box: 43375-1116, Rasht-Iran

HEPARODIC 5000 (Heparin sodium 5000U/mlIV, Deep SC Injection IV infusionEach 1ml ampule (injectable solution) contains:Heparin sodium USP……5000IUBenzyl alcohol B.P……9.45 MGSodium chloride B.P…….. 9 mgWater for injection USP……..q.s

Form 5-A

Dy No. 958 R& I DRAP dated 17-3-2014

Fee deposited: Rs. 50000/- dated 07-11-2012 + Rs. 50000/- dated 31-12-2014

Balance fee: Nil

Legalized COPP available from Islamic Republic of Iran

Product License No. IRC 1228049750 dated 04-7-2011

Legalized Free Sale Certificate available from the country of origin

Me too


f. Cases of Imported Human Biological Drugs ENOXAPRIN M/s Allmed Laboratories, Karachi

S.No. Name of Importer & Manufacturer

Brand Name &Composition

Dy No & Date of application/

Fee Status/Pack size/ Price

Document details (CoPP)/ International availability/Me too status

Decision in 257th RB Meeting

1. M/s Allmed Laboratories, A-21/3 KDA Scheme No. 1 Ext Karachi Pakistan

Les Laboratories Medis Route De Nabeul Km 78000 Nabeul Tunise

ENOXA 2000 IU anti Xa 20mg Solution Injectable 2 Syringes / 0.2 ml

One prefilled syringe of 0.2 ml contains:Enoxaparin Sodium ……20mg

Antithrombotic

Dy No. 1140 R&I dated 23-5-2014

15000 dated 02-1-201285000/- dated 11-10-2012

As per PRC/ Pack of 2’s syringes

Market authorization no. 9233494 until valid 05-2017Sole agency agreement dated 23-11-2015

Clexane prefilled syringes

Deferred for expert opinion of following:a. Dr. Abid

Azhar, A.Q.Khan Institute of Biotechnology, University of Karachi.

b. Dr. Zeeshan Danish, University


(MHRA)

Clexane PFS of Sanofi Karachi

of the Punjab.

c. Prof. Dr Ghias Butt, PIMS Islamabad.





Antithrombotic

Dy No. nil R&I dated 26/5/2014

15000 dated 02-1-201285000/- dated 11-10-2012



Clexane prefilled syringes (MHRA)




b. Dr. Zeeshan Danish, University of the Punjab.






Antithrombotic

Dy No. 1139 R&I dated 23/5/2014

15000 dated 02-1-201285000/- dated 11-10-2012














Antithrombotic

Dy No. 1141 R&I dated 23/5/2014

15000 dated 22-11-201185000 dated 11-11-2011









The expert opinion of above products have no been received yet.


g: Cases of Imported Human Biological Drugs Heparin sodium 25000IU M/s Genome Phamra, Rawalpindi

S.No. Name of Importer & Manufacturer

Brand Name &Composition


Fee Status/Pack size/ Price

Document details (CoPP)/ International availability/Me too status

1. Genome Phamra, Rawalpindi

Belmedpreparaty RUE Republic of Belarus

NEFRIN Injection

Each 5 ml contains:Heparin sodium 25000IU

Pharmacological group: Anti

Form 5-A


Fee deposited Rs.100000/- dated 30-12-

Legalized valid COPP is required As the firm has submitted copy of COPP issued on dated 07-8-2014.

Copy of sole agency agreement is submitted.


cogualant

Shelf life : 03years

2015

Price: Not provided.

Orignal legalized documents are required.

Decision: Registration Board approved NEFRIN Injection as per Import Policy for Finished Drugs. The firm will provide the original legalized CoPP and sole agency agreement and Chairman RB will allow further processing of the case as per Import Policy for Finished Drugs.

Deferred/ Miscellenous Cases

Case No.06: Following product of M/s BroMed animal Health, Lahore are deferred in the 258 th meetin

of RB due to non submission of original legalized GMP Certrificate. The firm has now provided the

legalized GMP certificate. The case is placed before the board for consideration please.

Sr. No



Type of Form


Fee submitted




Remarks Decision

1. BroMed animal Health, Lahore

Middle East for Vaccines (ME VAC)Industrial area 2 Piece 22-24, New Salhia, el Sharkia Head Office : 20 Jospeh teto el nozha el gededa, Cairo, Egypt.

TRI-APHTHOVAC

Inactivated Foot & mouth Tri-vlent Vaccine Strain A Iran05, O Pan Asia 2, Asia 2, Asia 1 Shamir

Each ldose (2ml) contains:

Inactivated FMD Virus Serotype A Iran 05……≥ 108

TCID50 per dose. (4 ug of viral


Fee deposited: Rs.100000/- dated 18-12-2015.

20/50/100/300 ml vial

Product Reg No 614 Dated 19/02/2014Legalized Free sale dated 17-09-2015

The Firm has submitted GMP certificate legalized through Embassy of Pakistan


Approved As Per Valid Legalized COPP And Import Policy For Finished Drugs


protein / Dose which is equivalent to 6 PD50/ dose).

Inactivated FMD Virus Serotype O Panasia 2……≥ 108 TCID50 per dose. (4 ug of viral protein / Dose which is equivalent to 6 PD50/ dose).

Inactivated FMD Virus Serotype Asia 1 Shamir…..……≥ 108 TCID50 per dose. (4 ug of viral protein / Dose which is equivalent to 6 PD50/ dose).

Montanide Isa 50…….1mlInactivant BEI……….3mMBulk saline…………..Q.S. to2mlTotal ……….2 mlProtection of cattle dairy sheep goat from FMD

Shelf life: 24 months Route : SC


ME FLUVAC H9+ND 0.3%Inactivated Bivalent Virus


Product Reg No 653Legalized Free sale

The Firm has submitted GMP certificate legalized

Approved As Per Valid Legalized COPP And



Vaccine against Avian influenza H9N2 and Newcastle disease.

Composition:Inactivated Avian Influenza A /Chicken /Egypt/114940v/NLQP /2011 (H9N2)……≥108EID50/dose before inactivation.

Inactivated Newcastle Disease NDV/Chicken/Egypt/11478AF/2011 (ND)……≥108EID50/dose before inactivation.

Mantonied Isa 71VG…021 mlBNE ……..0.0005 GBulk saline …… Q.S.to 0.3mlTotal ….. 0.3ml

Protection against AI, and ND

Shelf life 24 monthsRoute: IM/SC

Fee deposited ; Rs.100000/- dated 16-12-2015 vide challan no. 0131605

300 ml vial

dated 17-09-2015

through Embassy of Pakistan


Import Policy For Finished Drugs


MEVAC IB+NDInactivated trivalent Virus Vaccine of

Dy.No. 2844 (R&I) DRAP dated 21-12-2015

Product Reg No 630Legalized Original free

The Firm has submitted GMP certificate legalized

Approved As Per Valid Legalized COPP And


Middle East for Veterinary Vaccines (ME VAC)Egypt.

Infectious Bronchitis Disease.

Each (0.5ml) ml contains:

Inactivated Virus Vaccine of Infectious Bronchitis Disease of IB Classical (Eg/11539F)& IB Variant type 2 (Eg/1212B)……≥107EID50/dose at release.

Inactivated Newcastle Disease NDV/Chicken/Egypt/11478AF/2011 (ND)……≥108EID50/dose at release (>128PD50).

Mantonied Isa 70V……0.35 mlFormaldehyde solution …..0.0045ml

Bulk saline …… Q.S.to 0.5mlTotal …. 0.5mlImmunization against IB and ND

Shelf life: 24

Fee deposited; Rs.100000/- dated 16-12-2015 vide challan no.0131609.

500 & 300 ml vial

sale certificate dated 20-06-2015

through embassy of Pakistan.


Import Policy For Finished Drugs


monthsRoute : IM/ SC



ME FLUVAC H9 0.3%(Inactivated virus Vaccine against Avian influenza H9N2)

Each (0.3ml) dose contains:

Inactivated Avian Influenza A /Chicken /Egypt/114940v/NLQP /2011(H9N2)……≥108EID50/dose before inactivation.

Protection against influenza

Shelf life: 24 monthsRoute : IM/ SC


Fee deposited: Rs. 100000/- dated 16-12-2015. vide challan no. 0131604.

Packs: 300 ml vial

Legalized Original free sale certificate dated 20-06-2015






ME VAC ND BroilerInactivated Virus Vaccine against Newcastle disease

Each 0.3 ml dose contains:

Inactivated Newcastle Disease NDV/Chicken/Egypt/11478AF/2


Fee deposited: Rs. 100000/- dated 16-12-2015 vide challan no. 0131607.

300 ml vial

Legalized Original free sale certificate dated 20-06-2015Product reg no 651 dt 8/5/2014





011 (ND)……≥108EID50/dose before inactivation.

Protection against ND

Shelf life: 24 monthsRoute : IM/ SC

Case No.07: Cases of Imported Products of Veterinary Biological Drugs M/s SNAM Pharma, Lahore

M/s Snam Pharma, Lahore applied the new registration of following Veterinary Biological

Products. The Registration Board considers the request in 256 th Registration Board meeting. The decision

of 256th RB meeting is below:

Decision of 256thRB: Approved as per import Policy for Finished Drugs.

The firm is provided registration certificates of three (03) Eastern Europe Countries as per Import Policy. Product details as under:

Sr #.Name of Indenter/ Manufacturer

Manufacturer Name of Drug (s)/ Composition & Therapeutic Group


Documentary Details

Remarks

1. M/s SNAM Pharma 61-G Defense Housing Authority , Lahore

BIOVETA, a. s. Komenskeho 212, 683 23 Ivanovice na Hane, Czech Republic,

Biofel PCH emulsion for injection for cats

Active Substance

Virus panleucopeniae contagiosae felis inactivatum, satrain FPV-Bio 7

Calicivirus felis

Date of application25-11-2014

Fee deposited

Rs.100000/- vide Challan

CoPP No. 047/2014 dated 01-4-2014

Prod License No. 97/004/06-C dated 01-06-2006

Free Sale Certificate No.

Me too

1. Marketing Country: Romania

Market authorization No. 130217dated 22-11-2013.

2. Marketing Country: Republic of Poland


inactivatum, strain FCV F 9-Bio 8

Herpesvirus felis inactivatum, strain FHV-1-Bio 9

No 0227880 dated 27-11-2014

Balance feeNil

048/2014 dated 01-4-2014

GMP Certificate No. 178/2012/CGMP dated 03-9-2012

Authorization No. 2398/14 dated 18-12-2014

3. Marketing Country: Hungary

Marketing Authorization No.3612/1/14 NEBIH ATI (1dose) dated 1-12-2014

2. M/s SNAM Pharma 61-G Defense Housing Authority , Lahore

BIOVETA, a. s. Komenskeho 212, 683 23 Ivanovice na Hane, Czech Republic,

Biocan Puppy lyophilisate for the preparation of injection suspension with diluent

Composition- 1 ml (1 dose):a) Component D (freeze-dried)Virus febris contagiosae canis min. 10 4.2 TCID50

– MAX. 10 5,0 TCID50

b) Component P (fluid)Parvovirus enteritidis canis inact. Min. 1024 HAU- max. 4096 HAU

Date of application25-11-2014

Fee deposited

Rs.100000/- vide Challan No 0227879 dated 27-11-2014

Balance feeNil

CoPP No. 057/2014 dated 01-4-2014


Free Sale Certificate No. 058/2014 dated 01-4-2014


Me too

1. Marketing Country: Romania

Market authorization No. 120087 dated 21-3-2012.

2. Marketing Country: Slovak Republic

Market authorization No. 97/115/99-S dated 12-12-2012

3. Marketing Country: Republic of Bulgaria

Marketing Authorization of Veterinary product No, 0022-1461 dated 14-7-2015

3. M/s SNAM Pharma 61-

BIOVETA, a. s.

Biocan DHPPi+L lyophilisate for

Date of applicat

CoPP No. 209/2014

Me too


G Defense Housing Authority , Lahore

Komenskeho 212, 683 23 Ivanovice na Hane, Czech Republic,

the preparation of injection suspension with diluent

Composition- 1 ml:

Freeze-dried ComponentVirus febris contagiosae canis min. 10 3.0 TCID50

– max. 10 4.5 TCID50

Virus laryngotracheitidis contagiosae canis min. 10 3.5 TCID50 – max. 10 4.5 TCID50

Parvovirus enteritidis canis min. 10 4.5 TCID50

– max. 10 5.5 TCID50

Virus parainfluensis canis min. 10 3.0 TCID50 – max. 10 4.2 TCID50

b) Liquid component

Leptospira icterohaemorrhagiae inact. Min.titre 32 defined by MAT*)

ion25-11-2014

Fee deposited

Rs.100000/- vide Challan No 0227878 dated 27-11-2014

Balance feeNil

dated 03-7-2014


Free Sale Certificate No. 210/2014 dated 03-7-2014


1. Marketing Country: Hellenic Republic (Greece)

Marketing authorization No. 81940 dated 22-9-2014.

2. Marketing Country: Republic of Poland

Authorization No. 2010/10 dated 21-10-2010

3. Marketing Country: Hungary

Marketing Authorization No, 250/1/09 MgSzH ATI (1dose) dated 21-4-2015


Leptospira canicola inact. Min.titre 32 defined by MAT*)

Leptospira grippotyphosa inact. Min.titre 32 defined by MAT*)*) geometrical mean of titres of specific antibodies defined by microagglutination test

3. Two Veterinary Biological Products namely Biocan Puppy (lyophilisate for the preparation of injection) and Biocan DHPPi+L (lyophilisate for the preparation of injection ) of M/s Snam Phamra, Lahore deferred in 256th Registration Board meeting for expert opinion of confirmation of need vis-à-vis compatibility with local immunogenic requirement safety profile product.

Pannel of experts are as under:

a. Dr. Qurban Ali Animal Husbandary Commissioner, Ministry of National Food Security, Islamabad.

b. Prof. Dr. Khushi Muhammad, UVAS, Lahorec. Prof.Akram Munir, Ripha University, Lahore1. The opinion of Prof. Dr. Khushi Muhamad against Biocan DHPPi and Biocan Puppy Vaccine are as under:

Comments: Based on the “quality control data, results of the experimental trails and composition of the Vaccines”, it can be stated that vaccines against the said canine disease in Pakistan seem to be safe and effective.

It is therefore recommended that the said vaccines may be registered in Pakistan in the best interest of canine lovers.

2. The opinion of Prof. Dr. Muhamad Akram Muneer, Riphah International University, Lahore against Biocan DHPPi and Biocan Puppy lyophilisate Vaccine are as under:


Comments against Biocan Puppy lyophilisate:The technical data provided in the dossier supports the efficacy of this vaccine product against CD Aand CPV. In view of supporting documents I recommend that the registration of this vaccine may be considered by the Registration Board.

Comments against Biocan DHPPi+L lyophilisate: The technical data support the efficacy of this multivalent vaccine against canine distemper (CDV), infectious canine hepatitis (CAV-1), infectious laryngotracheitis (CAV-2), parvovirus infection (CPV), parainfluenza (CPIV-2) vivid and leptospirosis in dogs. I recommend consideration of this multivalent preparation by the registration board.

3. The Opinion of Dr. Qurban Ali, DG, NVL, Islamabad against Biocan Puppy lyophilisate and Biocan DHPPi+L lyophilisate are as under:

Biocan Puppy lyophilized is a two component vaccine for active immunization of dogs against canise distemper and parvovirus. The subject vaccine is a veterinary requirement especially for the pet dogs in the country. The dossier has merits of clear description of technical contents. The product is registered in the country of origin, multiple European and developed and developing countries. The product is recommended.

Biocan DHPPi+L is a multicomponent veterinary caccine containing veterinary vaccine containing freeze dried and liquid components having biological entities. The vaccine is required for pet dogs for immunization against multiple diseases for the age of eight weks and above. The technical application has scientific contents with clear description of technical details. The product is registered in country of origin, multiple developed and developing countries. The product is recommended.

Decision: Registration Board approved avove Product as per Import Policy for Finished Drugs. The firm shall provide legalized and Notarized COPP from three regulatory bodies of Eastern European countries, where the drug is registered for purpose of the waiver of inspection aborad as required as per Import Policy for Finished Drugs.

Case No.08: Deferred cases Registration of Products of M/s Mustafa Brothers, Faisalabad

Following veterinary vaccine products of M/s Mustafa Brothers Faisalabad are deferred for

submission of valid legalized documents i.e. CoPP or Free sale certificate with GMP, issued by the

regulatory agency of country of origin with certified English translation in 257 th meeting of Registration

Board. The firm has submitted the documents. The evaluation is detailed below for consideration of

Registration Baord please.

S. No





Me too status

Remarks

1. Mustafa Brothers

Virus Vaccine against infectious

Dy. No.600 (R&I) dated

State Registration No.

Firm has submitted valid


Faisalabad.

Manufacturer

Federal Governmental Budgetary Institution “Federal Centre for Animal Health” (FGBI “ARRIAH”, Vladimir, Russia.

bursal disease from BG strain “ARRIAH GUMBORO VAC”Contains:-Infectivity of the virus vaccine shall be at least 104.5EID50/cm3 One dose of the vaccine shall contain 103 EId50(Vaccine).Pharmacological group:Vaccine.

12-6-2012

Fee Rs.15000/- dated 12-6-2012 + 85000/- dated 01-2-2016

Balance FeeNil

1047796296437 dated 11-8-2011

DML No.00-11-1-001221 dated 11-8-2011

GMP Registration N 4-4060 enclosed

lealized documents i.e. Free sale certificate with GMP issued by the regulatory agency of country of origin with English translation


2. Mustafa Brothers Faisalabad.

Manufacturer


Vaccine against chicken infectious bronchitis from strain “H-120” strain live dry Contains:-

One immunizing vaccine dose contains not less than 104 EID50 of the chicken infectious bronchitis virus (‘H-120” strain, serotype Massachusetts).

Pharmacological group:Vaccine

Dy No. 599 (R&I) dated 12-6-2012Fee Rs. 15000/- dated 12-6-2012 + 85000/- dated 01-2-2016

Balance fee Nil

Product Registration No. 1023/301283720 Dated 26-7-2011

State Registration No.1047796296437Dated 26-12-2011

Legalized Free sale Certificate Registration N 1-2347 enclosed

GMP Registration N 4-4060 encosed.

.Firm has submitted valid lealized documents i.e. Free sale certificate with GMP issued by the regulatory agency of country of origin with English translation



Manufacturer

Federal Governmental

Associated Vaccine Against Newcastle DiseaseInfectious Chicken Bronchitis and egg drop syndrome-76 inactivated emulsion

Date of application12-Jun-2012

Fee Rs.15000/- dated 12-6-2012+ 85000/- dated 01-2-

DML No. 00-11-1-001220 Dated 11-8-2011 enclosed.

Legalized Free Sale Certificate No. N 1-2346

Firm has submitted valid lealized documents i.e. Free sale certificate with GMP issued by the regulatory


Budgetary Institution “Federal Centre for Animal Health” (FGBI “ARRIAH”, Vladimir, Russia.

Pharmacological group:Vaccine for prevention of Newcastle DiseaseInfectious Chicken Bronchitis and egg drop syndrome-76 in breeding and marketable pultry farms and farms of other categories that have poultry.

2016Balance FeeNIL

Packing of 400 doses in a bottle.

encosed.

GMP Certificate No. N 4-4060 copy enclosed.

agency of country of origin with English translation



Manufacturer


Virus vaccine against Bursal disease from Winterfield Disease 2512 strain

One Immunizing dose of vaccine shall contain:4,0 lg EID50 of attenuated virus of infectious bursal disease of Winter field strain 2512

Composition:

Active substances:Virus of infectious bursal disease (IBDV) (strain Winterfield-2512), titer of infectivity at lease 6.0 lg EID50/cm3.

Pharmacological group:The vaccine is used for prophylactic immunization of chickens and chicks against infectious bursal disease.

Dy No. 596 (R&I) dated 12-6-2012

Fee Rs. 15000/- dated 12-6-2012

85000/- dated 01-2-2016

Balance FeeNil

Prod Reg No. 1023301283720Dated 26-7-2011

GMP No. 0011-1-00122126-12-2011

Free Sale Certificate No. 4-4078

Firm has submitted valid lealized documents i.e. Free sale certificate with GMP issued by the regulatory agency of country of origin with English translation




Manufacturer


Virus Vaccine against infectious bursal disease from BG strain “ARRIAH GUMBORO VAC”Contains:-Infectivity of the virus vaccine shall be at least 104.5EID50/cm3 One dose of the vaccine shall contain 103 EId50(Vaccine).Pharmacological group:Vaccine.

Dy. No.600 (R&I) dated 12-6-2012

Fee Rs.15000/- dated 12-6-2012 + 85000/- dated 01-2-2016

Balance FeeNil

State Registration No. 1047796296437 dated 11-8-2011

DML No.00-11-1-001221 dated 11-8-2011

GMP Registration N 4-4060 enclosed

Firm has submitted valid lealized documents i.e. Free sale certificate with GMP issued by the regulatory agency of country of origin with English translation


Decision: Registration Board approved above five products as per Import Policy for Finished Drugs and valid legalized COPP

Case No.09: Change in Name of company and address already registered and unregistered products of M/s Sanofi-Aventis Pakistan Ltd.

M/s Sanofi-Aventis Paksitan has applied for the change in name of company and address for the following products:

i. Shanvac B 1ml (Reg.No. 0456371) already registerd product.ii. Shanvac B 0.5ml (Approved in 240th RB meeting and under process in Pricing)iii. Shanvac B 5ml MD (Approved in 240th RB meeting and under process in Pricing)iv. Shan TT 0.5ml single vial (Approved in 240th meeting of RB and 12th DPC.v. Shan TT 0.5ml SD (35x0.5ml) (Approved in 240th meeting of RB and 12th

DPC.vi. Shan TT 5ml MD (30x5ml) (Approved in 240th meeting of RB and 12th

DPC.

M/s Sanofi-Aventis Pakistan Ltd has requested that the state of Andhra Pradesh by virtue of the

Andhra Pradesh Reorganization Act 2014 has been split in to two states Andhra Pradesh and Telangtana

fro mid of 2014.

As a result of Reorganization Act the manufacturing unit located in erstwhile Andhra Pradesh are

now came into existence in the reorganized Telangana and as per fresh certificate of incorporation


consequent upon conversion from public company to private company issued by ministry of corporate

affairs, w.e.f. 19-11-2014. The change of name and address details are as under:

Old Name of Company and Address New Name of Company and address

Shantha biotechnics Limited

Survey No. 274, Athvelli village, Medchal Mandal – 501401, Ranga Reddy district, Andhra Pradesh, India

Shantha biotechnics Private Limited

Survey No. 274, Athvelli village, Medchal Mandal – 501401, Ranga Reddy district, Telangana, India

Firm has submitted fee against each product Rs. 5000/- , Legalized COPP and other legal documents.

Decision: Keeping in view the approval of change of name and address by the regulatory body of exporting country (valid legalized CoPP), the Registration Board approved the change of name and address of manufacturer from Shantha biotechnics Limited Survey No. 274, Athvelli village, Medchal Mandal – 501401, Ranga Reddy district, Andhra Pradesh, India to Shantha biotechnics Private Limited Survey No. 274, Athvelli village, Medchal Mandal – 501401, Ranga Reddy district, Telangana, India.

Case No.10: Deferred Case of 256th RB, Request for additional pack size by M/s. Snam Pharma, Lahore.

M/s Snam Pharma Lahore may be advised to submit the separate application / dossier

alongwith COPP and case may be taken up in the next Registration Board meeting. However the opinion

of Secretary, Registration Board may also be taken on the instant case for further clarification.

Product Biocan R injection is registered Veterinary Product in multiple dose vial (Reg.No.

057167). The firm requested additional volume/ pack in single dose form as per COPP issued by

regulatory body of Czech Republic. The Registration Board acceded to the request of firm in 256 th RB

meeting. Now the clarification is needed wether the firm shall follows the policy of submitting separate

application dossier along with full fee as per policy adopted on human drugs.

The firm has submitted the balance fee of 95000/- other formalities are complete. Case is submitted

before board please.

Decision: Registration Board deferred the request of additional pack volume 1ml x 20 doses of Biocan R bearing Registration No. 057167 and advised to submit application on Form-5A with requisite details.


Case No.11: Transition of Formulation from Lyophilized To Liquid Form of WinRho SDF Injection (025216) M/s Eastern Trade and Distribution Co. Pvt Limited Karachi

M/s Eastern Trade and Distribution Co. Pvt Limited Karachi have informed that their

principal M/s Cangene Corporation, Canada is transitioning the formulation of their registered product

WinRho SDF Injection from lyophilized to Liquid formulation. The existing formulation was supplied as

freeze dried powder I vial along with single ampoule of sterile water for injection, while the new

formulation is liquid injection will contain a convenient formulation ready to use 3ml single dose vial of

1500IU (300mcg) of Anti Rho (D) in glass vial

The liquid formulation is approved by Health Canada, detailed below:

Existing WinRho SDF Lyophilized formulation composition

New approved SDF Liquid formulation

Each vial contains:Human Anti-D Immunoglobulin (in house)………300 mcg

Glycine Ph. Eur/ USP……22.5 mgSaodium chloride Ph. Eur/ USP…..7 mgPloysorbate 80 Ph. Eur/ USP…..0.3mgWater for Injection Ph. Eur/ USP……QS *

* Removed by lyophilization.

Each vial contains:Human Anti-D Immunoglobulin (in house)………300 mcg

Maltose USP………………..0.135gPloysorbate 80 Ph. Eur/ USP…..0.39mgWater for Injection Ph. Eur/ USP……QS *

The firm has submitted the following documents:

a. 5000 fee in respect of above applicationb. Copy of registration letter along with renewal evidence.c. USFDA Approval and CoPP issued by Health Canada for liquid formulation.d. Specifications of new excipients.e. Data of long term (36 months) and accelerated (6months) stability studies.

If approved by the board, we may direct the firm to apply afresh, as it is new dosage design. The case

is submitted for consideration of Board please.

Decision: Registration board did not acceed to the request of the firm for change of formulation from lyophilized to liquid form of Winrho SDF injection (025216) as present formulation is also approved by regulatory authority of Canada. However firm was advised to apply fresh application with prescribed fee for new formulation/ dosage design.


Case No:12 Reditux TM Injection applied by M/s Macter International Limited

S. No


Brand Name /Drug composition



Me too status Remarks

Decision of RB

1. Macter International (Pvt) Limited, Karachi.

Dr. Reddy’s Laboratories Ltd., Ranga Reddy District, Hyderabad, India.

Reditux TM Injection 100mg Each 10ml vialcontains :-Rituximab (r-DNA origin)…............. 100mg(Antineoplastic Monoclonal Antibody).(For Human Use)

Original Notarized and Legalized GMP certificate no. 259//M3B/2014 issued by Drug Control Administration, Andhra Pradesh. Date Of Issue 13/02/2014 and valid up to 18/12/2015. COPP no. 2821/M3B/2014 for finished drug of strength 100 mg issued by Drug Control Administration, Govt. of Andhra Pradesh. Original notarized and Legalized. Valid up to 18/12/2015.

Indications:

Date of application2.02.2011

Fee deposided15000 (02-2-2011)+85000 (09-10-2011)

Total. 100000

Balance fee Nil

Structural similarity of subject biological product is available in provided DMF by manufacturer.Protein sequence is compared with WHO sequence.

The reference product is Ristova by Roche. The case was recommended in 48th ECBD + Biosimilarity +PICSCopies of COPP provided, valid up to 18-12-2015.

Bioequivalence and efficacy Clinical trials data is submittedSafety StudiesFour years post marketing surveillance data of 818 patients.

Animal toxicity studies are available in provided DMF by

Deferred for expert opinion of followinga. Brig (Retd), Muzamil Hasain Najmi, foundation Medical College, Rawalpindib. Brig. Amir Ikram, AFIP, Rawalpindi.c. Dr. Masud-ur-Rehman DDG, DRAP, Islamabad.


Non Hodgkin Lymphoma Antineoplastic Monoclonal Antibody

manufacturer

2. Macter International (Pvt) Limited, Karachi.

Dr. Reddy’s Laboratories Ltd., Ranga Reddy District, Hyderabad, India

Reditux TM Injection 500mg Each 50ml vialcontains :-Rituximab (r-DNA origin)…...........… 500mg (Antineoplastic Monoclonal Antibody).(For Human Use)

COPP no. 2381/M3B/2014 issued by Drug Control Administration, Govt. of Andhra Pradesh. Date Of Issue 22/03/2014. Valid up to 18/12/2015. Original notarized and Legalized

Indications:Non Hodgkin Lymphoma Antineoplastic Monoclonal Antibody

Date of application02.02.2011

Fee deposited15000+85000

Balance fee Nil

Animal toxicity studies are available in provided DMF by manufacturer

The reference product is Ristova by Roche. The case was recommended in 48th ECBD + Biosimilarity +PICSCopies of COPP provided, valid up to 18-12-2015.

Bioequivalence and efficacy Clinical trials data is submittedSafety Studies:Four years post marketing surveillance data of 818 patients.

Deferred for expert opinion of followinga. Brig (Retd), Muzamil Hasain Najmi, foundation Medical College, Rawalpindib. Brig. Amir Ikram, AFIP, Rawalpindi.c. Dr. Masud-ur-Rehman DDG, DRAP, Islamabad.

1. EXPERT OPINIONS BY BRIG. (Retd) PROF MUZAMIL HASAN NAJMI, ON PRODUCTS (BIOLOGICAL) OF M/S MACTER INTERNATIONAL, KARACHI.


Rituximab is a chimeric monoclonal antibody produced by recombinant DNA technique. It reacts with the CD20 protein present on the surface of B lymphocytes which are thus destroyed. Reduction in the number of B lymphocytes results in decreased antibody production by these cells.

The drug is approved for treatment of certain leukemias and lymphomas including non-Hodgkin’s lymphoma. It is also used in some of the autoimmune diseases. It is a disease modifying drug for rheumatoid arthritis, particularly refractory to other treatments.The drug can cause several adverse effects which include severe reaction after administration as infusion, cardiotoxicity, lung toxicity, tumor lysis syndrome and reactivation of viral infections including hepatitis B. However, keeping in view the nature of diseases in which it is used, the benefit/risk ratio is favorable.

M/S Macter International, Karachi has applied for registration of the brand of Rituximab which is of Indian origin. The manufacturer, Dr. Reddy’s Lab has provided details of manufacturing method and biosimilarity studies of their product, Reditux TM injection 100 and 500 mg. The Company has obtained cGMP compliance certificates from USFDA and MHRA of UK. Having reviewed the data provided, I am of the opinion that both strengths of Reditux TM injection may be approved so that a cost-effective alternative brand of this drug may become available for the patients.

2. EXPERT OPINION BY DR. MASUD UR REHMAN, DDG, DRAP ON BIOLOGICAL PRODUCT OF M/S MACTER INTERNATIONAL, KARACHI Introduction:

Rituximab a long chain monoclonal antibody is produced by recombinant DNA technique. Having site of action on CD20 protein present on the surface of B lymphocytes. It binds there and destroys B Lymphocytes cancerous cell. Reduction in the number of B lymphocytes results in decreased antibody production by these cells. The drug is approved for treatment of leukemias, lymphomas including non-Hodgkin’s lymphoma. It is also used in some of the autoimmune diseases. It is a disease modifying drug for rheumatoid arthritis, particularly refractory to other treatments.

Evaluation of Dossier:Product dossier carries scientific data of structural characterization & comparability with

innovator product (Mabthera / Rituxan) in peptide mapping, intact protein mass, UV circular dichorism, Disulphide bonding pattern by LC-MS. There is comparability / similarity of structure in high order structure by fluorescence spectroscopy, thermal stability by scanning calorimetric method, glycosialation analysis by Reagent Array Analysis (RAAM), Charge isomers by IEF, SDS PAGE, SEC HPLC. Potency is determined by CDC & ADCC. Specific binding of FCγR1, FCγRIIa, FCγRIIB, FCγRIIIa and FCγRn regions by ELISA, SPR & FACS has also been done.

Pharmacokinetic studies:

Pharmacokinetic and extensive animal toxicology studies data is provided. Clinical efficacy trial on Non Hodgkin Lymphoma (NHL) of stage II, III and IV patients has shown overall response of 93.8%.


Toxicity data is also provided which is in acceptable range. Four years post marketing safety data of 808 patients is also submitted.

Manufacturers Profile:

Manufacturer of Rituximab is Dr. Reddy’s Laboratories, India. Its a GMP certified manufacturer by many international regulatory agencies such as Brazil, Peru, QP EU, GCC and Iran. The Company has also obtained cGMP compliance certificates from USFDA and MHRA of UK.

Recommendations:

M/S Macter International, Karachi has applied for registration of the generic brand of Rituximab. Reditux generic biosimiler injection may be approved so that a cost-effective alternative brand of this drug may become available for the patients. Based on aforementioned evaluated specifications by M/S Macter International, Karachi, the product registration is recommended.

3. Reply of Brig. Amir Ikram, AFIP, Rawalpindi

Thanks for referring the case of Reditux TM Injection 100mg and 500mg strength. Comments are as below:

1. Product Safety: The provided literature shows that the preparation s are safe. Trials have been conducted in the country f origin with satisfactory outcome. The manufacturer is following GMPs.

2. Efficacy; The clinical trials conducted in the contry of origin indicate that the preparations are efficacious, however further evaliuation if requisite may be done.

3. The provided material indicates that the preparations are comparable to published literature for innovator rituximab. The preparations are required and if probably not incorrect not much of preparations are easily available within the country. Its transportation under requisite parameters especially temperature has to be guaranteed by the company at all levels.

The three experts have recommended the products for registration. The case is submitted is before the board for consideration as per import policy.

Decision: Registration Board considered the expert opinions and approved the registration of Reditux Injection 500mg manufactured by Dr. Reddy’s Laboratories Ltd., Ranga Reddy District, Hyderabad, India as per Import Policy for Finished Drugs and valid legalized CoPP

Case No.13: Hepatitis B Vaccine applied by M/s Macter International Limited.

Following products of M/s Macter International Limited Karachi for local manufacturing were

deferred in the 257th meeting of Registration Board for confirmation of manufacturing facility.

S.#. Name of Brand Date of Documentary Remarks


Importer/Manufactruer

Name /Composition

application/Fee status/price

details

1. Macter International Ltd. 216, SITE, Karachi, Pakistan (Local Manufacturer)

Bulk material source:

LG Life Sciences Korea.

Biovac HB

(Recombinant Hepatitis B Vaccine)

20 µg/ml

Out Dy No. 184 dated 10.3.2014

20000/- dated 21-8-2013

Price. As per PRC

Me too

Legalized CoPP No. 2-13-A1-1023 Republic of Korea


Legalized Free sale certificate No. 2013-A1-1022 dated 08-5-2013

Legalized GMP Dated 15-3-2013 enclosed.

a. Firm has submitted the CoPP FSC and GMP of bulk material issued from regulatory body of Korea.

b. Under finished product specifications firm has provided, tests of Physical appearance, aluminum content, Potency by Elisa, identification and purity by SDS-Page, endotoxin bioburden and sterility tests.

2. Macter International Ltd. 216, SITE, Karachi, Pakistan (Local Manufacturer)

Bulk material source:

LG Life Sciences Korea.

Biovac HB

(Recombinant Hepatitis B Vaccine)

10 µg/0.5ml

Dy No.40 DDC (BD) Dated 17-3-2014

Fee Rs. 20000/-

Dated 21-8-2013

Price: As per PRC

Me too

Legalized CoPP No. 2015-A1-0917 Dated 16-7-2015


a. Firm has submitted the CoPP FSC and GMP of bulk material issued from regulatory body of Korea.

b. Under finished product specifications firm has provided, tests of Physical appearance, aluminum content,


Legalized GMP No. 2015-F1-0102 dated 09-4-2015

Potency by Elisa, identification and purity by SDS-Page, endotoxin bioburden and sterility tests.

The firm has submitted that:

Macter’s Biotech manufacturing license covers the formulation, filling and packing of

recombinant DNA technology products. Hepatitis B vaccine is also recombinant DNA technology protein

which is relevant to the license. Recombinant human hepatitis B antigen (rHBsAg) is a polypeptide

protein of 226 amino acid with molecular weight of 24 KDa produced by incorporating genes that code

for important antigens (HBV envelope proteins) into common baker’s yeast (Saccharomyces cerevisiae).

This polypeptide is similar in nature to any other biopharmaceutical products like Interferon alpha which

is 19Kda polypeptide.

This vaccine is entirely different to other categories of vaccines which contain live attenuated or

killed pathogenic organisms (fully or partially). Ready to fill bulk vaccine will be imported from LG South

Korea which is WHO qualified manufacturer for this vaccine (WHO letter for qualification is submitted.

Weblink of WHO site of prequalified manufacturers of rHBsAG is given. Formulated bulk will be

imported and Firm will do filling in vials with online sterile filtration. Details of availability of QC

equipments is attached. Firm has submitted quality & stability data of three batches manufactured

locally. ADC signed invoice of import of ready to fill bulk is provided. Firm’s Biotech manufacturing

license covers the formulation, filling and packing of recombinant DNA technology products. Hepatitis B

vaccine is also recombinant DNA technology protein which is relevant to the license.

Sr. no.

Documents/ data as per requirement of DRB 246

Documents / data submitted by Macter

Remarks

1. Legalized GMP certificate of biological drug as evidence that manufacturer is an authorized manufacturer of that particular biological drug in its country of origin

Legalized GMP certificate by KFDA issued on March 15, 2013.

Notarized and legalized (by Pakistan embassy Soule, South Korea) GMP certificate Issued by Korea Food & Drug Administration on March 15, 2013 is submitted. WHO pre-qualification letter Issued by Coordinator quality, safety and standard is submitted.


WHO prequalification certificate and Web link of WHO website link https://extranet.who.int/gavi/PQ_Web/  for WHO prequalified vaccine manufacturers included in GAVI program is provided. Legalized COPP certificate no. 2013-A1-1023 issued on May 08, 2013 is provided.

This product & manufacturer are included in the list of prequalified vaccines & manufacturer at WHO web link https://extranet.who.int/gavi/PQ_Web/. Notarized and legalized (by Pakistan embassy Soule, South Korea) COPP certificate no. 2013-A1-1023 issued on May 08, 2013 is provided.

2. Structural similarity of subject biological drug product (ready to fill bulk) with reference biological product (innovator).

Product characterization is performed for comparability with WHO reference standard of NIBSC Hep B antigen & innovators product Engerix B of GSK by SDS PAGE (mol. Wt.), UV spectrophotometry (identification), Circular Dichorism (secondary structure), electron microscopy (particle morphology), gradient centrifugation (density), gradient Centrifugation (homogeneity), Tryptic digestion & SDS Page, N Terminal sequence (identity), C terminal sequencing (identity), Amino acid composition, thin layer chromatography (phospholipid composition), Antigenicity by ELISA (efficacy), Size Exclusion Charmatography and SDS page for purity,

Studies are performed by LG life Sciences South Korea are available in provided CTD dossier.

3. Bio comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity / potency testing and toxicity with support of IEF data, gel electrophoresis, western blot and other analytical methods and stability studies of finished drug.

Comparative analysis of locally produced drug product with Reference medicinal product (Engerix B). Identity: SDS PAGE Purity: SDS PAGE Potency: ELISA General safety tests Bacterial Endotoxin test, Sterility test and abnormal toxicity test. Real time stability studies for one year and accelerated stability studies for 6 months.

Comparative studies of local batches with innovators product Engerix B of GSK are provided.

4. Others Animal toxicity studies and clinical trial studies are submitted

Pharmacokinetics and toxicological studies are provided.


https://extranet.who.int/gavi/PQ_Web/

https://extranet.who.int/gavi/PQ_Web/

Section 5.2 requires that dedicated nd self contained facilities for production of particular drug

shall be provided in addition to general facilities sch as highly sensitizing materials ( pencillins or biologicals

preperation, live microorganisams or cytotoxix substances or radio pharamaceuticals or veterinaray

immunological preparation or sterile products or for that matter such hihky active pharmaceutical products,

antibiotics, hormones, as may be identified by the CLB at any stage in order to minimize the risk of serious

medical hazards due to cross contamination, veterinary products contaioning ingrdients similar to those used for

human health and of the sane quality which can be manufactured in the same premises used for manfacture of

pharamacetical products.

It is also described under the above sub rule in exceptional cases of emergency, the prociple of campaign

working in the same facilities may be allowed provided that the specific precautions are taken nd necessary

validations are made.

It is submitted that a discussion was carried out with Licensing Division to discuss the manufacturing

facility for vaccines and other biological products should be separate or can be manufacutered in the same

biotech facility. The Licensing Divisin has desired to make a comprehensive and well thoughtfull delimitation

of manufacturing process being careied out, so the Biological Division and Licensing Division may come up

with comprehensive proposal in the light of existing legislation and international practices being adopted. It is

proposed that the board may allow adaptation of WHO guideline in this regard. (Annex-I)

The case is submitted before the Board for a discussion/delibration/direction on the subject issue by the

Registration Board.

Decision: Regiatration Board deliberated and deferred these applications that manufacturing and quality control of biological products require specialized facilities and approval from the Licensing Division, DRAP. The Baord dicussed that theses manufacturing units have already been granted registrations of various biological products for local manufacturing (mostly therapeutic proteins). As theses firms have applied for registration for local manufacturing of various biological products including rDNA products, Theraputic protein, Monocronial antibodies, Vaccines (Live, Attentuated, rDNA vaccines, so the Board decided to have opinion of licensing division DRAP regarding approved manufacturing facilities (categories of biological products) of these firms and status of already registerd biological drugs from these firms.

Case No.14: Cases of Import Veterinary Product Medivac ND G7B Emulsion and Medivac Coryza T Suspension M/s Hilton Pharma, Karachi.

S.No.

Name of Importer & Manufactur




Remarks Decision


er Fee submitted

Pack size

Me too status

1. Hilton Pharma (Pvt) Ltd.13, Sector 15, Korangi Industrial Area, Karachi, Pakistan

Manufacturer:Name: PT.MEDION

JI.Raya Batujajar 29 cimareme, Kabupaten Bandung-Indonesia

Adress: Ji. Babakan ciparay No. 282 Bandung 40223 - Indoneshia

Medivac ND G7B Emulsion

Each dose (0.5ml) of vaccine contains inactivated Newcastle disease virus MD15 strain at least 50 PD 50

Inactivated vaccine for poultry

Dy No. 196 R&I dated 12-3-2014

100000/- dated 18-9-2013

Pack Size

500 ml

Legalized Certificate of Free Sale No. 10004/PL500/F/02/2016 valid until January, 2021

Product Registration Kementan RI No. D-13034471 VTC

Legalized GMP Certificate No. 086/MFJ/HK.340/F.5/08/11 Dated 23-8-2011 until valid 23-8-2016

Authorization Letter No. RD/IJ/III/2016/C141 dated30-3-2016 from Medion Bandung-Indonesia.

Firm has submitted Legalized Free Sale Certificate, GMP Certificate, Letter of authorization and Product Stability Data.

Approved as per Import Policy for Finished Drugs and valid legalized CoPP.

2. Hilton Pharma (Pvt) Ltd.13, Sector 15, Korangi Industrial Area, Karachi, Pakistan

Manufacturer

Medivac Coryza T Suspension

Strrength / Formulation

Each 0.5ml dose contains:-Haemophillus paragallinarum W strain before

Dy No. 543 R&I dated 04-6-2014

100000/- dated 04-6-2014

Pack Size

500 ml

Legalized Certificate of Free Sale No. 10004/PL500/F/02/2016

Product Registration Kementan RI No. D-14022729 VTC.1

Firm has submitted Legalized Free Sale Certificate, GMP Certificate, Letter of authorization and Product Stability Data.

Approved as per Import Policy for Finished Drugs and valid legalized CoPP.


:Name: PT.MEDION

JI.Raya Batujajar 29 cimareme, Kabupaten Bandung-Indonesia

Address: Ji. Babakan ciparay No. 282 Bandung 40223 - Indoneshia

inactivation ≥2x108.0 CFU/ml-Haemophillus paragallinarum Spross strain before inactivation ≥2x108.0 CFU/ml-Haemophillus paragallinarum Modesto strain before inactivation ≥2x108.0 CFU/ml

Inactivated Suspension Vaccine against infectious coryza

Legalized GMP Certificate No. 086/MFJ/HK.340/F.5/08/11 Dated 23-8-2011 until valid 23-8-2016

Authorization Letter No. RD/IJ/III/2016/C141 dated30-3-2016 from Medion Bandung-Indonesia.

Case No.15: Deferred Cases of 257th Meetong of Registration Board of M/s Amson Vaccines Pharma (Pvt) Ltd Rawalpindi (WHO Prequalified)

S.No Name of Importer/Manufacturer

Brand Name / Composition

Date of application/fee status/ Price/pacsk

Dicision of 257RB Meeting

Documents submitted by M/s Amson Vaccine Phamra, Islamabad

Decision

1. M/s Amson Vaccines & Pharma (Pvt) Ltd. Rawalpindi Pakistan

Manufacturer

M/s. Biiological E Limited

ComBE Five (Suspension for Injection).

Diphtheria, Tetanus, Pertussis (Whole cell), Hepatitis B (rDNA) and Haemophilus Type b Conjugate Vaccine (Adsorbed)


Fee Rs. 100000/- dated 25-2-2016

Pack size:

1ml – Two dose

Deferred for submission of following documents :

a. Sole agency agreement.

b. Valid legalized CoPP.

Legalized COPP No. COPP/RLA/DI/MDL/HYD/2016 valid upto 03-9-2017

Legalized GMP Certificate No. Dis.No. 10694/E(V)/TS/2015 dated 04/9/2015 valid for two years from the date of issue

Legalized Sole Agency Agreement

Registration Board approved the product as per import policy, Import policy order (Ministry of Commerce) and as per valid legalized CoPP.

WHO prequalification status shall be verified at the time of issuance of


18 / 1 7 3, Azamabad, Hyderabad, India-500 020.

Each dose of 0.5 ml contains:

Diphtheria Toxoid : 25 Lf (≥30IU)

Tetanus toxooid : 5.5 Lf (≥60IU).

B. Pertussis : 161 IOU Lf (≥ 4 IU)

r-HBs Ag : 12.5 µg.

Purified capsular polysaccharide of Hib covalently : 11 µg.

Linked to 20 to 36.7 µg of tetanus toxoid.

A1+++ (as AIPO4) : ≤1.25 mg

Preservative: Thiomersal BP : 0.01% w/v

Pharmacological group:

Vaccine

Shelf life: 24 months, when stored at 2-8oC.

dated 6thApril, 2016 submitted.

registration letter.

2. M/s Amson Vaccines & Pharma (Pvt) Ltd. Rawalpindi Pakistan

Manufacturer


Diphtheria, Tetanus, Pertussis (Whole cell), Hepatitis B (rDNA) and

Dy No. 708 R&I DRAP dated 03-2-2016.

Fee Rs. 100000/- dated 03-2-

Deferred for submission of following documents:



Legalized COPP No. DI/BPN/Sec(Mfg)/COPP /18.03.16-02 valid up to 25-7-2016 Submitted

Legalized GMP Certificate No. Dis

Registration Board approved the product as per import policy, Import policy order (Ministry of Commerce) and as per valid legalized




Haemophilus Type b Conjugate Vaccine (Adsorbed)








A1+++ (as AIPO4) : ≤1.25 mg



Vaccine

2016

Shelf life: 24 months when stored at 2-8oC.

Pack Size: 2.5 ml Five dose)

No. 1610/M3B/2014 dated 26-7-2014 valid for two years from the date of issue. Submitted

Legalized Sole Agency Agreement dated 7th April, 2016 submitted.

CoPP.

WHO prequalification status shall be verified at the time of issuance of registration letter.

3. M/s Amson Vaccines & Pharma (Pvt) Ltd. Rawalpindi




Legalized COPP No. COPP/RLA/DI/MDL/HYD/2016 valid upto

Registration Board approved the product as per import policy,


Pakistan

Manufacturer



Diphtheria, Tetanus, Pertussis (Whole cell), Hepatitis B (rDNA) and Haemophilus Type b Conjugate Vaccine (Adsorbed)








A1+++ (as AIPO4) : ≤1.25 mg



Fee Rs. 100000/- dated 10-3-2016

Pack size:

5ml – Ten dose

Shelf life: 24 months, when stored at 2-8oC.



03-9-2017 submitted

Legalized Sole Agency Agreement dated 6th April , 2016 submitted

Legalized GMP Certificate No. Dis No. 10694/E(V)/TS/2015 dated 04-9-2015 valid for two years from the date of issue. submitted

Import policy order (Ministry of Commerce) and as per valid legalized CoPP.



Vaccine

4. Amson Vaccines & Pharma (Pvt) Ltd. Rawalpindi Pakistan

Manufacturer

M/s Biological E Limited

18/1&3, Azamabad, Hyderabad – INDIA, 500 020

BEtt

(Adsorbed Tetanus Vaccine [Tetanus Toxoid Vaccine]

Each 0.5 mL of vaccine contains:

Tetanus Toxoid……..≥40 IU

Adsorbed on Aluminium Phosphate (AIPO4)……. ≥1.5 mg

Preservative: Thiomersal BP…….0.01% w/v

Pharmacolgical group:

Vaccine

Indications:

For active immunization against tetanus in adults, children and infants.

Dy No. 707 (R&I) DRAP Dated 03-2-2016

Fee Rs. 100000/-

Dated 03-2-2016

Ten dose vial of 5ml



b. Legalized valid CoPP or Free Sale Certficate and GMP certificate.

Legalized COPP no. COPP /RLA/DI/MDL/HYD/2016 valid upto 20-10-2016 from Govt of Telangana submitted.

Legalized GMP Certificate NO. L.Dis No. 8010/AB/(M3)/TS/2014 dated 21-10-2014 valid for two years the date of issuance

Legalized Sole Agency Agreement dated 07-4-2016 submitted

Registration Board approved the product as per import policy, Import policy order (Ministry of Commerce) and as per valid legalized CoPP.


5. Amson Vaccines & Pharma (Pvt) Ltd. Rawalpindi Pakistan

Manufacturer

BEtt

(Adsorbed Tetanus Vaccine [Tetanus Toxoid Vaccine]

Dy No. 1215(R&I) DRAP Dated 25-2-2016

Fee Rs. 100000/-



b. Legalized valid CoPP or Free

Legalized COPP No. COPP/RLA/DI/MDL/HYD/2016 valid upto 20-1—2016 submitted

Legalized Sole Agency Agreement

Registration Board approved the product as per import policy, Import policy order (Ministry of Commerce) and as per valid legalized


M/s Biological E Limited

18/1&3, Azamabad, Hyderabad – INDIA, 500 020

Each 0.5 mL of vaccine contains:

Tetanus Toxoid……..≥40 IU

Adsorbed on Aluminium Phosphate (AIPO4)……. ≥1.5 mg

Preservative: Thiomersal BP…….0.01% w/v

Pharmacolgical group:

Vaccine

Indications:

For active immunization against tetanus in adults, children and infants.

Dated 27-01-2016

Single dose vial of 0.5ml

Sale Certficate a and GMP certificate.

dated 7th April, 2016 submitted.

Legalized GMP Certificate No. Di. No, 8010/AB/(M3)/TS/2014 dated 21-10-2014 valid for two years from the date of issue. Submitted

CoPP.


Case No. 16. Deferred case of 256 Meeting of Registration Board for expert opinion M/s Marush (Pvt) Limited, Lahore

M/s Marush (Pvt) Limited, Lahore has applied for the registration of following biological products

which were considered in the 256th meeting of Registration board. The board deferred the request of

the firm for expert opinion.

Name of Manufacturer Name of product & composition


Vaxxinova GmbH Anton-Flettner-Str. 6 27472 Cuxhaven, Germany Distributed by: CEVA SANTE ANIMALE 10 avenue de la Ballastiere Libourne, 33500 France

Cevac new Flu H9 KEach dose contains:-Atleast 109.0 EID50 of inactivated Newcastle disease Virus (strain LaSota) and atleast 108.0 EID50 Avian Influenza Virus (strain H9N2), suspended in the amnio-allantoic fluid from embryonated SPF hen’s eggs.

Laboratories Hipra S.A.Avda. La Selva Amer (Girona) Spain.

Hipraviar SHSEach dose contains:Live Turkey Rhinotracheitis Virus, strain 1062---------≥102.4 TCID50Excipiants q.s……….0.03 ml

-do-. Hipraviar B1/H1201 dose contains:Live Newcastle disease (ND) Virus, strain B1………….105.5 EID50

Live infectious bronchitis (IB) Virus, strain H120…………..………….103 EID50

The Reply of experts is as under:

Reply of Dr. Iftikhar Hussain

Based on the data provided in the respective dossiers, the products seem to contain the required antigenic masses of the respective viral strain present in the product for effective amount of antibody productions, the above mentioned products may be considered for registration.

Reply of Dr. Muhamad Khalil

In the light of current local epidemiology Newcastle (ND), infectious bronchitis (IB) are the mostprevalent diseases in local commercial layer, broiler & breeder farms, whereaa swollen head syndrome (SHS) is common disease problem of commercial layer & breeding flocks. All types of chickens in Paksitan are being vaccinated regularly against these diseases through similar combinations as of the subject vaccines. It is also cited in the literature that similar vaccines are also carried out in Pakistan and world wide where commercial poultry is grown.

Keeping in view the local epidemiology, data presented and review of the literature. I feel the subject veterinary biologics are suitable for prevention of above cited diseases.

Therefore, I recommend to register these vaccines in Pakistan.

Reply of Dr. Masood Rabbani, UVAS, Lahore is still awaited

The case is submitted before the board for consideration please.

Decision: Registration Board considered the expert opinions and approved the registration of Cevac new Flu H9 K, Hipraviar SHS, Hipraviar B1/H120 vaccine


Case No.17. Deferred Cases of 257th Me too of Registration Board of Sanofi-Aventis Pakistan Limited, Karachi

Name of Importer/Manufacturer

Brand Name / Composition

Date of application/fee status/ Price/pacsk

Dicision of 257RB Meeting

Documents submitted by Sanofi-Aventis Pakistan Limited, Karachi

Decision

Sanofi-Aventis Pakistan Limited, Karachi

Product License holder (also packager, labeler & batch release):

Genzyme Corporation, 11Forbes Road, Northborough, MA USA

Manufacturer:

Hospira Inc. 1776 North Centennial Drive McPherson, KS 67460USA

THYROGEN

(Thyrotropin alfa, thyrotropin alfa for injection)

Each vial contain 1.1mg thyrotropin alfa (Each 1 ml contains 0.9 mg/ml of thyrotropin alfa when reconstituted with 1.2 ml water for injection)


Pituitary and Hypothalamic Hormones and Analogues,

Shelf life: three years.

Application submit (R&I) Section dated

09-6-2014

Fee Rs. 100000/-

Dated 09-6-2014

To be submitted at time of price fixation/ box of 2vials.

Deferred for submission of following:

a. Legalized CoPP/ GMP & Free Sale Certifcate.

b. Orignal sole agency agreement.

c. Stability data of finished product.

The firm has submitted Legalized

COPP No. 04-0013-2014-02-PK Dated 29/4/2014

Product License Holder No. 20-898 dated 30-11-1998

GMP Certificate No. UK GMP 24655 Insp GMP 22907/37128-0005 [H] dated 31-12-2012.

The stability data has also been submitted.

The Product is USFDA approved, so Registration Board approved the registration of product as per import policy and valid legalized CoPP.


Case No.18: Deferred Cases of M/s Acumen Pharmaceuticals Rawalpindi in the 258 th meeting of Registration Board

Following product of M/s Acumen Pharmaceuticals Rawalpindi, are deferred in the 258 th

meeting of registration board for submission of valid legalized CoPP from country of origin and if not

available in the country of origin, then valid reason thereof.

Sr. No Name of Importer & Manufacturer


Type of Form

Dy No & Date of application/Fee status/

Pack size/ demanded Price


International Avalaibality

Me too status

Remarks Decision of 258th RB

1. AcumenPharmaceuticals,Rawalpindi

BBT BiotechGmbH Arnold Sommerfeldring28 52499BaeswilerGermany.

DICLAIR HP-HCGFor Injection

Each vial contains:Human Chorionic Gonadotopin………….5000IU

Treatment of an ovulatory infertility

Shelf life 36 months

Dy No. 258 dated 13-1-15

Rs. 100000/- dated 13-1-2015

Price 1500/vial

Legalized /original COPP NO 109-07-14 dated 19-7-2014 of Federal Agency 97 Medicine and health Belgium.

Me too

Legalized CoPP of Belgium submitted Product is not available in the country of origin .( declared for export). Molecule is me too.

Deferred for submission of valid legalized CoPP from country of origin and if not available in the country of origin, then valid reason thereof.


BBT BiotechGmbHArnoldSommerfeldring

DICLAIR HP-FSHEach vial contains:

Folical stimulating Hormone

Form 5A

Dy No. 260 dated 13-1-2015

Rs. 100000/- dated 131-15

COPP No. 209-07-14 dated 19-7-2014 (Copy submitted) Federal Agency 97 Medicine and

Legalized CoPP of Belgium submitted Product is not available in the

Deferred for submission of valid legalized CoPP from country of origin and if not available in the country of


28 52499BaeswilerGermany.

75IU

Induction of ovulation


Price 1500/vial

health Beljium.

country of origin. (declared for export). Molecule is me too.

origin, then valid reason thereof.


BBT BiotechGmbHArnoldSommerfeldring28 52499BaeswilerGermany.

DICLAIR HP-HMGEach vial contains: Folical stimulating Hormone 75IU

Luteinizing hormone 75IU


Dy No. 259 dated 13-1-15

Rs. 100000/- dated 131-15

Price 1500/vial

Legalized /original COPP NO 1023-12-14 dated 23-12-2014 of Federal Agency 97 Medicine and health Beljium

Legalized CoPP of Belgium submitted Product is not available in the country of origin .( declared for export). Molecule is me too.

Deferred for submission of valid legalized CoPP from country of origin and if not available in the country of origin, then valid reason thereof.

The firm has submitted a letter from BBT Bio Tech GmbH Germany that the above products are not marketed in European markets yet, as there was no economical interest for that.

All registration s made in our home market, are only of interest in case the product can have a status of reimbursement. The social security of western European countries were not reimbursing the human gonadotrophin until recently.

As European authorities do change the rules of re-imbursment, giving our products (gonadotrophin) an economical reason to be registered, we can inform that we are now starting MRP registration process. This process will take some time as we will then cover all countries of the ECC.

Therefore we can conclude that BBT-Biotech GmbH is starting now registration procedures for, consecutively, HMG, HCG and FSH, throughpartners and /or in direct form.

Our manufacturing sites/facilities are fully GMP/WHO approved. All necessary authorizations are available including the CPP format declaring that sales on export are allowed by our Ministry of Health.

Decision: Registraion Board considered the request of the firm. The reason submitted by the firm for non registration of products in country of origin was from the manufacturer and not from the regulatory body. The board is of the view that the reason is not sufficient for granting registration. The board deferred the products till registration in the country of origin as per policy


Case No. 19 Deferred case of 258th Meeting of RB M/s LDS (Pvt) Ltd Rawalpindi.

Sr. No



Type of Form


Fee status/

Pack size/ demanded Price

Document details (CoPP)/

International Avalaibality/ Me too status

Decision of 258th Meeting of RB / Remarks

Decision

1. M/s LDS (Pvt) Ltd Rawalpindi.

M/s BioMed Pvt Ltd C-96 site No.1 Bulandshar Road Industrial Areal Ghaziabad UP India.

PEDA TYPH Vaccine single dose vial

Each dose vial 0.5ml contains:

5ug of Vi polysaccharide of Salmonella typhi conjugated to 5ug Tetanus toxoid protein in isotonic saline 0.5ml.

Immunization against salmonella in infants of age ≥ 6 months children and adults

Shelf Life 36months

Dy No. 502 dated 22-1-15

Rs. 50000/- dated 22-1-2015

Single dose vial Rs.495/-

Legalized COPP NO. Drug/837/403 valid upto 23-1-2016 from India

Defered in 258th RB meeting for confirmation of formulation in reference drug agencies and submission of valid legalized CoPP.

The firm has submitted only legalized free sale certificate.

Confirmation of fee is required

Approval of product in reference agencies is required.

Deferred for submission of valid legalized CoPP/ FSC and GMP, evidence of approval of product in reference agencies and WHO prequalification status as per import policy order for importibilty from India

2. M/s LDS (Pvt) Bio Typh Form 5-(A) Legalized COPP The firm has Deferred for


Ltd Rawalpindi.

M/s BioMed Pvt Ltd C-96 site No.1 Bulandshar Road Industrial Areal Ghaziabad UP India.

(Tphoid vaccine)

Single dose vial , Multi (5) dose vial

Each dose of (0.5 ml) contains: Vi polysaccharide of Salmonella typhi (strain ty2)-25mcg Isotonic saline I.P. q.s.- 0.5ml

Proposed dosage

a. For adults : 0.5 ml

b. Children by age group : 0.5 ml (after 2 years of age)

c. Infants & special groups : Not recommended

Pharmacological group: Vaccine

Route of administration : Intramuscular or subcutaneous

Clinical use: Recommended for prevention of typhoid fever.

Date of application

53 DDC (BD) dated 22-1-16

Fee deposited; Rs.50000/- dated 20-1-2016

Demande price; single dose vial Rs.160/- and Multi dose vial Rs. 525/-

Pack size:

1. Single dose vial

2. Multi (5) dose vial

No. Drug/837/403 dated 23-1-2016 from India.

Product License No. 05/LVP/Sera & Vaccines/2004 dated 20-5-2004

Free sale certificate No. Drug/837/37 dated 16-1-2015 from the country of origin

Letter of authorization No. BM/PK/LDS/BT/071015 dated 07-10-2015 from the country of origin.

submitted only legalized free sale certificate.

Confirmation of fee is required

MHRA approved

submission of following

a. Valid legalized CoPP/ FSC and GMP,

b. WHO prequalification status as per import policy orders for importibilty from India.

c. Clarification from the firm for selection of pack size.

Case No.20 Case of M/s. Graton Pharma, Karachi for registration of Interferon Alfa 2B 3000IU /Vial (Lipheron from Beijing Shanglu, China) along with diluent.


The firm M/s. Graton Pharma, Karachi has informed that they applied for the registration of

Interferon Alfa 2b 300MIU injections 22.6. 2011. The request consider in 256th Registratin Board meeting

and deferred for expert opinion. The product details is as under;

S.No Company Name

Name of Manufacturer

Name of Products


Documentary Details

1. M/s Graton Pharma office # 102, First Floor, The Plaza, Block-9 Clifton, Karachi.

Beijing SL Pharmaceutical Co., Ltd.

No.9. Zhongyuan Road, Badachu High Tech. Park, Shijingshan District, Beijing, P.R.China

Recombinant Human Interferon alfa 2b for injection

Strength: 3M IU/vial

Date of application

Fee Deposited

Rs.15000/- dated 22-6-2011 + 35000/- dated 09-10-2012+ 50000/- dated 11-6-2015

CoPP No. 20150204 dated 10-2-2015

Prod License No. S20100501 dated 18-9-2010.

GMP Certificate No. CN 20130327 DATED 31-10-2013

Free Sale Certificate No. 2015-14 dated 02-1-2015 validity 02 years.

The firm has now submitted the legalized CoPP No . 20150204 dated 10-2-2015 Prod License No. H20100501 dated 18-09-2010. Submitted for consideration of Registration Board please.

Decision: Registration Board considered the case and referred the above application of the firm for expert opinion by following experts:

a. Brig (R), Muzamil Hussain Najmi, Member Registration Board.b. Brig. Amir Ikram, AFIP Rawalpindi.c. Dr. Masud-ur-Rehman, DDG, DRAP, Islamabad.

Inspection of the manufacturer abroad can be conducted after the expert opinion.


Expert Opinions are as under:

1. EXPERT OPINION OF BRIG. AAMER IKRAM, AFIP, RAWALPINDI

Thanks for referring the case; comments are as below:

1. Product Safety:

The Preparation seems to be safe. The original manufactures is following GMPs. Toxicological reports after testing are also attached and are satisfactory. Post market surveillance is also satisfactory.

2. Efficiency:

The provided literature shows that the preparation is efficacious. The trials have been conducted in the country of origin. Further trials may be done here if required.

3. Themolecular descriptin seems satisfactory. The preparation is required; however its transportation under requisite parameters especially temperature has to be ensured by the company at all levels.

2. EXPERT OPINION OF DR. MASUD UR REHMAN, ADDITIONAL DIRECTOR (BIOLOGICAL DIVISION) DRAP, FOR (LIPHERON) INTERFERON ALPHA 2B 3000 IU OF M/S GRATON PHARMA, KARACHI, IS AS UNDER:

Introduction: Human interferon-α 2a or 2b are well-known characterized proteins consisting of 165 amino acids. The non-glycosylated protein has a molecular weight of approx. 19,240 KD. It contains two disulfide bonds, one between the cysteine residues 1 and 98, and the other between the cysteine residues 29 and 138. The sequence contains potential O-glycosylation sites. Physico-chemical and biological methods are available for characterisation of the proteins. Recombinant IFN-α 2a or 2b is approved in a wide variety of conditions such as viral hepatitis B & C, leukaemia, lymphoma, renal cell carcinoma and multiple myeloma. It is used alone or in combination in oncology indications. Interferon-alpha may have several pharmacodynamic effects. The sub-types Interferons alpha 2a and 2b have different clinical use. In general, interferon-α 2a or 2b use in oncology indications has reduced considerably had been superseded by other more effective specific treatments. Treatment with recombinant interferon alpha 2a or 2b is associated with a variety of adverse reactions such as flu-like illness, fatigue, and myalgia. A variety of immunemediated disorders such as thyroid disease, rheumatoid arthritis, systemic lupus erythematosus, neuropathies and vasculitis have been observed with r-IFN-α.

Pharmacology of Product:

The product Lipheron is produced by Beijing SL Pharmaceutical Company, it has provided general pharmacological action studies at (P 50) which are line with documented action of product as mentioned in intrduction. Interferon induce pleiotropic biologic responses which include antiviral, antiproliferative,


and immunomodulatory effects, regulation of cell surface major histocompatibility antigen (HLA class I and class II) expression and regulation of cytokine expression. Company has provided antiviral activity studies done in vivo using chi cell model (P 65).

Pharmacokinetics:

The pharmacokinetic properties of Interferons were evaluated in normal, healthy volunteer subjects after subcutaneous injection of 1 mcg, 3 mcg, or 9 mcg Interferons. Plasma levels of interferon after subcutaneous injection administration of any dose were too low to be detected by either enzyme-linked immunosorbent assay (ELISA) and by inhibition of viral cytopathic effect.

Antiviral Activity in Cell Culture:The antiviral activity of interferon against HCV or HCV-derived replicons in cell culture has been studied and were upto mark.

In vitro studies:

In order to compare any alterations in reactivity between the similar and the reference medicinal products, data from a number of comparative bioassays (e.g. receptor-binding studies, antiviral effects in cell culture, antiproliferative effects on human tumour cell lines), is provided. Standardised assays are used to measure activity and potency (p 65).

In vivo studies:

To support the comparability exercise for the sought clinical indications, the pharmacodynamic activity of the similar biological medicinal and the reference medicinal products quantitatively compared is provided:

An appropriate pharmacodynamic animal model (e.g. evaluating effects on pharmacodynamic markers of serum 2´,5´-oligoadenylate synthetase activity) are provided. Pharmacodynamic measurements are performed as part of repeat-dose toxicity studies. & provided (P 64). Toxicological studies data from toxicity study in a relevant species is provided. The study is performed in accordance with the requirements of the “Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance. A guidance for assessing systemic exposure in toxicological studies is provided. (P 62- 67)

• Data on local tolerance is also provided in accordance with the guidance on non clinical local tolerance testing of medicinal products.

• Safety pharmacology, reproduction toxicology, mutagenicity and carcinogenicity studies are also provided.

Clinical Studies:


Company provided phase II clinical trial to evaluate safety & tolerability in HCV patients (page 41) conclusion was that it is well tolerated. Company has provided phase II clinical trial to determine maximum tolerated dose in renal cell cancer patients (P 23). Company has provided phase III clinical trial in patients suffering from HBV, results and are in line with innovators (P 1-22). Company provided Phase IV clinical trial in patients suffering from HCV results are in line with innovators (P 33). Company provided post marketing surveillance data which is in line with published results of innovator on (P 44).

Pharmacovigilance plan: Company has provided a risk management programme / pharmacovigilance plan in

accordance with current WHO legislation and pharmacovigilance guidelines. Attention has been paid to immunogenicity and potentially rare and/or delayed serious adverse events, especially in patients undergoing chronic administration. Company also provided product recall system 74-78).

1) Safety of Lipheron; Company has provided following studies. Single dose toxicity data on mice. Repeat dose toxicity data on rats. Repeat dose toxicity data on Dogs. Genotoxicity & mutagenicity studies. Phase II human studies. Phase II human studies to determine maximum tolerated dose.

2) Efficacy of Lipheron; Company has provided following studies. Post marketing surveillance studies. Phase III trail. Multi-center study to determine efficacy. Phase IV study to demonstrate efficacy & safety, Phase II human studies. Phase II human studies to determine maximum tolerated dose

Structural Comparative Studies with Innovator:

The company has done purity studies by Chromatogram of purity by HPLC. UV Spectrum of Stack Spectra Image report. QC reort showing molecular weight, bands and standered lines. Isoelectric focusing spectrum, Peptide mapping and host cell DNA test has been done.

Administrative documents’ showing legalized GMP, evidence that manufacturer is authorized manufacturer in country of origin. The provided credentials show that Graton Pharma is their authorized agent. Provision of bio-comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity, clinical studies, stability studies of product, and certificate of analysis of finished product.

After detailed evaluation it is found that product is safe & have efficacy in different indications of (Recombinant Human Interferon Alpha 2 b) and shall be cost effective to poor


patients. Moreover result of Structure Comparison Studies is similar with Innovator Intron A. The authenticity of data / documents / adapted protocols cannot be verified here. At the

time of inspection of the firm, the authenticity of all provided documents, their systems / protocols of manufacturing / quality control / abnormal toxicity etc need to be evaluated on spot through vigilant inspection. The CoPP and GMP certificates legalized and notarized however confirm the availability of product in country of origin. Lipheron (interferon alpha 2 b 3000 IU) is hereby recommended for consideration of registration based on provided documents.

3. THIR EXPERT OPINION OF BRIG (R), MUZAMIL HUSSAIN NAJMI, MEMBER REGISTRATION BOARD, DRAP, IS STILL AWAITED.

Decision: Registration Board considered the expert opinions. The third expert Brig. Muzamil Hssain Najmi, whose reply was still awaited, also agreed to recommendations of other two experts. Based of the recommendations of all three experts, Registration Board approved the registration of Lipheron Injection (Recombinant Human Interferon alfa 2b for injection 3M IU vial) manufactured by M/s . Beijing SL Pharmaceutical Co., Ltd. No.9. Zhongyuan Road, Badachu High Tech. Park, Shijingshan District, Beijing, P.R.China as per import policy and valid legalized CoPP. The firm shall also submit separate Form 5A, fee and CoPP for registration of diluent.

Case No.21 DEFERRED CASE IN 257TH MEETING OF RB (DENGVAXIA, POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION (DENGUE TETRAVALENT VACCINE (LIVE, ATTENUATED). M/S SANOFI-AVENTIS PAKISTAN LIMITED, KARACHI

S.No.

Name of Importer/Manfacturer

Brand Name/Composition

Dateof application/Fee status/ Packs/Price

Documentary details

Decision of 257th RB Meeting

1. Sanofi-Aventis Pakistan Limited, Karachi

Manufacturer

Sanofi Pasteur Parc Industrial Incarville, 27100 Val de Reuil France.

DENGVAXIA, powder and solvent for suspension for Injection

(Dengue tetravalent vaccine (live, attenuated).

One dose (0.5 ml) contains:

Dy No. 940 (R&I) dated 16-2-2016

Fee Rs. 200000/- dated 15-2-2016 for powder and solvent

MRP 9500/- per dose

COPP NO. 20160108134504 Dated 25-1-2016 FDA Republic of Philippines.

Product License No. BR-1128 Dated 22-12-2015

Deferred for evaluation of clinical data by following experts:

a. Maj. Gen. Muhammad Aslam, Member Registration Board.

b. Dr. Huma, PMRC, Islamabad.

c. Represenrative of malaria


Final release site:

Sanofi Pasteur NVL 31-33 quai Armand Barbes 69250 Neuville-sur-Saone France.

CYD dengue virus serotype1,2,3,4………….each 4.5-6.0 log10 CCID50/dose


ATC code: J07BX

J (ANTINEFECTIVES FOR SYSTEMIC USE) 07 (VACCINES) B (VIRAL VACCINES) X (OTHER viral vaccines)

Pack size:

1. Powder (1 dose) in vial + 0.5 ml of solvent in pre-filled syringe with 2 separate needles (pack size of 1).

2. Powder (1 dose) in vial + 0.5 ml of solvent in pre-filled syringe with 2 separate needles (pack size of 10).

GMP Certificate No. HPF/FR/222/2015 Dated 05-10-2015

France

control, WHO Pakistan, Islamabad.

2. Sanofi-Aventis Pakistan Limited, Karachi

Manufacturer:

Sanofi Pasteur NVL 31-33 quai Armand Barbes 69250 Neuville-sur-Saone France.

DENGVAXIAT

M MD, powder and solvent for suspension for Injection

(Dengue tetravalent vaccine (live, attenuated).

One dose (0.5 ml) contains:

CYD dengue virus serotype1,2,3,4………….each 4.5-6.0 log10

Dy No. 941 (R&I) dated 16-2-2016

Fee Rs. 200000/- dated 15-2-2016 for powder and solvent

MRP 9500/- per dose Pack size:

1. Powder (5 doses) in vial + 2.5 ml of solvent in vial (pack size

COPP NO. 20160108134501 Dated 25-1-2016 FDA Republic of Philippines.

Product License No. BR-1129 Dated 22-12-2015

GMP Certificate No. HPF/FR/222/2015 Dated 05-10-

Deferred for evaluation of clinical data by following experts:

a. Maj. Gen. Muhammad Aslam, Member Registration Board.

b. Dr. Huma, PMRC, Islamabad.

c. Represenrative of malaria control, WHO Pakistan, Islamabad.


CCID50/dose


ATC code: J07BX

J (ANTINEFECTIVES FOR SYSTEMIC USE) 07 (VACCINES) B (VIRAL VACCINES) X (OTHER viral vaccines)

of 5). 2015

NVL SITE, France.

1. EXPERT OPINION OF DR. HUMA QURESHI, EXECUTIVE DIRECTOR, PMRC, ISLAMABAD IS AS UNDER:

The 1st dengue vaccine is produced by Sanofi and is licensed and being used in Mexico. It is also available on WHO website. Its phase 3 tgrials have been published in New England Journal of Medicine.

The vaccine is given in 3 doses at 0,6,12 month’s interval and has shown excellent protection in various dengue serotypes. For serotype 4, protection was seen in 77% for serotype 3 it was 71%, for type 2 it was 43% and for type 1 it was 54%.

Pakistan has been facing outbreaks of dengue infection since many years and each outbreak causes large morbidity, additional hospitalization cost and some ortality. Panic during outbreak causes huge out of pocket spending for undergoing various tests and treatments.

Evidence shows tht exposure to dengue and its recovery does not protect the individual from second exposure, in fact 2nd exposure makes the patient more vulnerable to complications like bleeding, shock and death.

A national study done all over Pakistan by Pakistan Medical Research Council in 2013, showed that 32% population who had no history of suffering from dengue fever had actually suffered from dengue fever, as seen by the presence of IgG antibodies in their blood. It can be stipulated from this study that a large population of Pakistan is vulnerable to dengue complications in every new outbreak.

It is therefore strongly recommended that dengue vaccine may be registered in Pakistanfor future ude and protection of the population.


2. EXPERT OPINION OF SYED KHALID SAEED BUKHARI, COUNTRY ADVISOR MEDICINE & HEALTH PRODUCTS, REPRESENTATIVE OF WHO PAKISTAN IS AS UNDER:

As you are aware that Dengue is a major health burden all across the world, which can affect anyone regardless of age, sex, underlying health, or socioeconomic status.

Pakistan is now considered Endemic for Dengue, and in order to limit Dengue, and integrated approach is optimal for prevention and contro of Dengue. Vector-control efforts prove to be unsustainable in preventing dengue disease; this gives rise to a need for the inclusion of a safe and effective dengue vaccine in Countries endemic with Dengue disease.

During the Q & A session with WHO in 2014, WHO commente4d that a safe, effective and affordable dengue vaccine would repreent amajor advance for the control of the disease and could be an important tool for reaching the WHO goal of reducing Dengue morbidity by at least 25% and mortality by at least 50% by 2020.

In March 2016, WHO Strategic Advisory Group of Experts on Immunization (SAGE) issued recommendations on Dengue vaccine that supports the use of the vaccine in endemic countries. The SAGE recommendations provide important validation of the efficacy, sfety, quality and potential public health value of the existing Dengue vaccine.

Based on the SAGE recommendations and the WHO initiative to control Dengue, it is theefore essential that Dengue vaccine is introduced in Pakista in ordr tolimit the burden of Dengue outbrteaks in the country.

The pricing of the Dengue vaccine should be as per the DRAP regulatory rules.

3. THIRD EXPERT OPINION OF MAJ. GEN. MUHAMMAD ASLAM, MEMBER REGISTRATION BOARD, DRAP, IS STILL AWAITED.

Recommendations of WHO Strategic Advisory Group of experts (SAGE):

The World Health Organization (WHO) Strategic Advisory Group of Experts (SAGE) on Immunization today issued recommendations on the use of the first licensed dengue vaccine. SAGE recommends countries consider introduction of CYDTDV, also known as Dengvaxia®, only in geographic settings (national or subnational) where dengue is highly prevalent. SAGE recommends that vaccination should be considered as an integrated strategy together with a communication strategy, well-executed and


sustained vector control, the best evidence-based clinical care for all patients with dengue, and robust dengue surveillance.

Dengue, also known as “breakbone fever,” is the most common mosquito-borne viral disease. Dengue causes about 390 million infections each year, putting at risk nearly half of the world’s population. To date, no specific treatment for dengue exists.

Dengue vaccines have been under development since the 1940s. In late 2015 and early 2016, the first dengue vaccine—Dengvaxia®, developed by Sanofi Pasteur—was approved by Mexico, the Philippines, Brazil, El Salvador and Paraguay for use in individuals 9-45 years old (9-60 years old in Paraguay) living in dengue-endemic areas. The world’s first public dengue immunization program started this month in the Philippines. Several other vaccine candidates are currently in clinical development, two of which are in advanced stages.

The new recommendations resulted from the SAGE meeting held this week in Geneva. SAGE consists of independent experts who advise the WHO on optimal use of vaccines through an evidence-based review process. The age to target for vaccination to maximize the reduction of dengue cases is projected to vary by transmission setting, but it will likely fall between 9 and 14 years of age. Dengvaxia® is not recommended for use in children under 9 years of age, consistent with the vaccine’s current labelling. These and other SAGE recommendations can be found here.

As SAGE emphasized, introduction requires careful assessment by each country. Such assessments should consider local priorities; national and subnational dengue epidemiology; predicted impact and cost-effectiveness with country-specific hospitalizations rates and costs; and affordability and budget impact.

If dengue vaccines are introduced, support for pharmacoviligance and post-introduction studies will be essential to monitor and evaluate countries’ experiences. Strategic communication will be critical for effective introduction and to inform partners and stakeholders about lessons learned on the use of Dengvaxia®. DVI will continue working to generate and disseminate evidence-based information that supports countries’ decisions on dengue vaccine introduction, as well as to raise the visibility of the challenges and opportunities ahead in dengue prevention and control.

Decision: Registration Board considerd the expert opinions and basesd on their recommendations and recommendations of WHO Strategic Advisory Group of experts (SAGE) on 15th April 2016 approved the grant of registration of DENGVAXIA, powder and solvent for suspension for Injection (Dengue tetravalent vaccine (live, attenuated) manufactured by Sanofi Pasteur Parc Industrial Incarville, 27100 Val de Reuil France and final release by M/s Sanofi Pasteur NVL 31-33 quai Armand Barbes 69250 Neuville-sur-Saone France, as per import policy. The firm shall provide the valid legalized CoPP issued by the regulatory body of France. The Chairman Registration Board shll allow the issuance of registration letter, if CoPP provided earlier than the next meeting of Regiration Board.

Case No.22: MEASLES VACCINE BY NIH, ISLAMABAD


It is submitted that NIH, Islamabad has applied for registration of Measles Virus Vaccine live

attenuated (dried Injectable (Measles virus)

The Registratin Board Approved the request of Measles Virus Vaccine Live attenuated (dried Injectable (Measles virus) in 256th Meeting of Registration Board. The Registration Board decided as follows:

Decision of 256th RB: “Keeping in view the above mentioned discussion, Registratin board approved the request of NIH, Islamabad for bulk import of measles vaccine concentrate from M/s Beijing Minhai biotechnology co-operative Ltd, No.1, S1 Miao road, bio-engineering & Pharmacetical Industrial park, Daxing district, Beijing, China and its local packing and labeling at NIH licensed facility for manufacturing of measle vaccine for supply to EPI. The NIH shall arranghe the test/ analysis of first batch from manufacturer at China and submit the reports to DRAP.”

Registratin Board also deliberated about the capacity of NIH for its installed facility where the NIH was once manufacturingits own vaccine from the measles virus seed. NIH representatives were also called to explain to the Registratin Board the circumstances under which the previous manufacturing could not be carried out. The NIH is of view that the seed culture is got out of stock and no one has showed its interest to supply the seed culture to NIH. The only way is import the bulkconcentrate from china its local repacking at NIH facility. NIH claimed that all the manufacturing of measles vaccine shall be for supply to EPI and its lot relaease will be through NCLB. The responsibility of quality, efficacy, and safety shall be of NIH. EPI shall report AEFI of the said vaccine.

It is to mention that FSC & GMP provided by the NIH of aforementioned manufacturer fromwhere they import bulk concentrate of measles vaccine, is of Combined Measles and Rubella Vaccine, Live Injection, However, the product applied for registration is Measles Virus Vaccine live attenuated (dried) Injectable. Since the submitted legalized documents are not align with information contained on Form-5 for issuance of market authjorization (Registration Certificate) as approved by the Registration board., Therefore the NIH was advised to submit clarification for measles bulk concentrate manufacturing authorization of the manufacturer abroad approved by SFDA.

In reply the NIH has submitted statement leter issued by M/s Minhai biotechnology co. Ltd China:-

“ we hereby certify that we are allowed to produce andexport vaccines mentined in the drug Manufacturing License, containing DTap-Hib vaccine, Live Attenuated combined vaccine of Measles and rubella,dtap vaccine, Hib conjugate vaccine,freeze-dried conjugate vaccine, 23-valent Pneumococcal Polysaccharide Vaccine, freeze-dried rabies vaccine for human use, small volume injectin and freeze-dried powder.

According to Chinese GMP regulation, there is no speprate license for the production of concentrate and bulk of vaccine, only the drug Manufactguring License of finsished product is available, which is also the license for all intermediate products.”

Decision: Registration Board deliberated on all the aspects of contentiotion of the Biological Division in lieu of previous decision of Registration Board. Technical Personels of NIH also assued that also neccessay precautions shall be adopted to import only measle


vaccine concentrate, as SFDA has granted approval to M/s Beijing Minhai biotechnology co-operative Ltd, No.1, S1 Miao road, bio-engineering & Pharmacetical Industrial park, Daxing district, Beijing, China for manufacturing of Rubella and measle vaccine. The Board finally reconfirmed its previous decision taken in 256th meeting and further advised to take extra caution by NIH to confirm the import of only measles virus concentrate and to avoid its mixing of rubella concentrate. The NIH shall also give undertaking in this regard.


Item No.IV: Quality Assurance & Lab Testing Division.

Case No.01: Manufacture & Sale of Sub-Standard Drug-Metrozole Suspension Batch No. 09121508 By M/S Marvi Pharmaceuticals, Karachi. F. No. 3-01/2016-QC

The sample of Metrozole Suspension Batch No. 09121508 manufactured by M/S Marvi Pharmaceuticals, Karachi drawn by FID Karachi from manufacturing premises on 21st December 2015 for test analysis. The sample was sent to the CDL Karachi, however the sample was declared Substandard vide test report No.R.KQ.415/2015 dated 13th January 2016. The result of CDL on the basis of which sample under reference has been declared sub-standard is under:-

pH. Determined:- 4.0

Limits:- 5.6 to 6.5 Does not comply BP 2014

The sample is of “Sub-Standard” quality under the Drug Act 1976.

On the explanation letter to the firm by the FID Karachi the firm challenged the CDL Test report in Appellate Laboratory NIH Islamabad under Section 22(5) of the Drugs Act 1976.

Result of Appellate Laboratory

pH:- Determined: 4.2 Limit:-5.0-6.5 Does not comply

Assay: Stated Found Limit Percentage

Metronidazole as 200mg/5ml 170.92mg/5ml 95.105% 85.46%Metronidazole benzoate Does not comply with BP-2013

U/s 42 of the Drugs Act 1976, rules framed there under and The DRAP Act 2012 show cause notices was issued to the firm and accused persons, offering opportunity of personal hearing before the Drug Registration Board. They have been called for personal hearing.

Decision: Mr. Pahlwan Tanvir, Plant Manager of the firm was appeared before the Registration Board on29-06-2016 and pleaded their case. He stated before the Board that there is some mistake in calculation in the report of Appellate Laboratory, which if corrected their sample would be passed in assay. The Honorable members of the Board after going through the said report found that there seems some mistake which may be typographical but needs to be clarified from the Appellate Laboratory (NIH ,Islamabad). The Board after


detailed discussion, deliberation, considering the facts and legal provision decided to defer the case to get the clarification from the Appellate Laboratory NIH Islamabad regarding the result of assay as percentage of contents was written as 190.31 while found 170.92 in 5ml.

Case No.02: Manufacture and Sale of Substandard “Regnum Syrup” Batch No. 7297 By M/s Novamed (Pvt) Ltd Lahore for M/s ICI Pakistan Limited , Karachi

The FID Karachi visited at the premises of M/s ICI Pakistan Limited 5-West Wharf Road,

Karachi on 19-03-2015. The FID took the sample of Regnum Syrup Batch No. 7297

Manufactured by M/s Novamed pharmaceuticals (Pvt) Ltd 28-Km Ferozpur Road Lahore, for the

test analysis and sent the above said sample to, CDL’s Karachi. However the FGA, declared the

sample as substandard quality vide its test report No.KQ.107/2015 dated 11th June 2015

Determined stated

Assay for amount/10ml: amount/10ml: Percentage:

Vitamin B2 1.482mg 1.2mg 123.5%Limits 90.0% to 150.0% complies Nicotinamide 11.721 mg 10.0mg 117.21%Limits 90.0% to 150.0% complies Vitamin C 17.61mg 50.0mg 35.22%Limits 90.0% to 200.0% Does not comply

On explanation letter issued by the FID, the firm challenged the CDL report and requested for

Appellate Testing under Section 22(5) of Drugs Act, 1976. The Appellate Laboratory has also

declared the sample as Substandard vide their test report 025-MNHRS/2015 dated 22nd October

2015.

Assay:- Stated Found Limit Percentage Vitamin B1 1.5mg/10ml 1.80mg/10ml 90-200% 120.04%Vitamin A 0.90mg/10ml 1.34mg/10ml 90-200% 148.94%Vitamin C 50mg/10ml 26.317mg/10ml 90-200% 52.635%Nicotinamide 10mg/10ml 13.123mg/10ml 90-150% 131.23%

Does not comply with manufacturers specification.


U/s 42 of the Drugs Act 1976, rules framed there under and The DRAP Act 2012 show cause

notices was issued to the firm and accused persons, offering opportunity of personal hearing

before the Drug Registration Board.

They have been called for personal hearing.

Decision: Mr. Muhammad Shahid Khan, Production Manager of the firm and Mr. Muhammad Jhangir, Quality Control Manger of the firm was appeared before the Registration Board on 29-06-2016 and pleaded their case. The representative of the firm stated that Regnum Syrup contains multiple ingredients in the formulation. As the product is in-house the testing method is also in –house. For the analysis of vitamin “C” they use iodometry titration and use of startch indicator by using preservative which is very critical to visualize the end point of the result. The firm representatives stated that as the formulation is liquid Glucose base which is very thick containing caramel colour, so it is very hard to watch the end point. So they developed and validated in- house method for the estimation of vitamin C. They stated that the Government Lab may have used the Redox titration for the analysis of vitamin C. The Board after detailed discussion, deliberation, considering the facts and legal provision decided to conduct the Product specific inspection of firm for complete investigation of case and confirming aforementioned statement of firm by performing complete analysis of Regnum Syrup before them.

i. Chairman Quality Control DRAP, Islamabad, ii. DTL Lahore.

iii. Area FID

Panel will submit its report in 30 days time for consideration by Registration Board.

Case No.03:

Test Reports declared by Federal Government Analyst that the fate of sample may kindly be decided under the guidance of Division of PE&R.

The Division of Quality Assurance DRAP Islamabad is receiving many reports from FGA, CDL Karachi like some of the following cases

Federal Government Analyst does not declare the sample of such ingredients which are used in both allopathic or non allopathic (or food supplement) allopathic drugs.

S.No. Name of Product and manufacturer

Test Report and dated

Identification Remarks of the CDL

1. Osteo Calcium + Calcium Plus Tablets manufactured by Zonex Pharma

R. LHR.222/2016 dated 12th May 2016

1) Calcium identified

2.) Vitamin D not identified

1) The label claims Nutritional Supplement

2) Vitamin D was


(Pvt) Ltd Lahore not identified as suspected by the Federal Inspector of Drugs concerned. However Calcium was found 340.68mg/tab

3.) The RDA (adults) for Calcium range is 1000-1200mg/day hence the assay result of Calcium is below the limits of the respective RDA

4.) Since Calcium is used in food supplements as per Pharmacopoeia and also by the allopathic manufacturers as a registered product therefore the fate of sample may kindly be decided under the guidance of Directorate of Registration DRAP Islamabad

2. Nucal 600mg Tablets manufactured by M/s Pak Nutraceuticals Karachi

R.KQ.61/2016 dated 27th April 2016

1) Calcium identified

2.) Vitamin D not identified

The label claims Natural Product

2) Assay result reveals that the sample contains calcium 400mg/tablet

3) Since Calcium is used in food supplements as per pharmacopoeia and also by the allopathic manufacturers as a registered product therefore the fate


of sample may kindly be decided under the guidance of Directorate of Registration DRAP

3. Juvederm Tablet manufactured by

R.IP.86/2015 Alphatacopheral Vitamin E identified

Ascorbic Acid not identified

The label claims Natural product

2.) Since Alphatocopheral Vitamin E is used in food supplements as per Pharmacopoeia and also by the allopathic manufacturer as a registered product therefore the fate of sample may be decided under the guidance of Directorate of Registration DRAP Islamabad

Decision: Registration Board deliberated that Division of Health & OTC, DRAP is functional and after the promulgation of DRAP Act 2012 Natural, Nutritional, Herbal and Homeo products etc come in the domain of aforementioned Division. Products referred by Government Analyst are not registered by Registration Board, hence such references will be sent to Health and OTC Division for deciding the matter

Case No.04: Manufacture & Sale of Sub-Standard Drug- Regogent Eye/Ear Drops Batch .No. E-058 Mfd. by M/s Amros Pharmaceutical Karachi. (F. No. 03-39/2014-QC)

Background of the case

The Assistant Drugs Controller (ADC), Karachi, Ms Ume Laila vide her letter date 15-07-2014 intimated that she took the sample of the drug under reference from the export consignment for Nigeria on 20-01-2014. It was further submitted that the drug sample has been declared as of substandard quality by FGA, Central Drug Laboratory (CDL), Karachi vide its test report No.EXP.19/2014, dated 14th July 2014. Salient features of the CDL test report are reproduced as under

Assay for Gentamycin :

Determined amount %w/v: 0.2535%


Calculated amount %w/v: 0.3%

Percentage: 84.5%

Limits: 90.0% to 135.0% Does not comply.

Remarks:- The sample is of “Substandard” quality under the Drugs Act, 1976.

As per examination of documents submitted, it was evident that the drug sample under reference was drawn by the ADC on 20-01-2014. However the CDL test report reflected that the sample was received in the Lab on 12-06-2014 meaning thereby the sample was sent to the Lab almost after four months and 21 days after its seizure for test/analysis. As per record of this office, it was also apprised that Board Portion of sample has not been received in the QC Section.

The ADC concerned was asked for explaining the reasons for not sending the sample to the CDL Karachi and disposing off the Board’s portion with in 07 days vide letter dated 16-09-2014.

In response, the ADC informed that the sample was delivered to the CDL on 20-01-2014 and acknowledgment receipt of CDL was furnished in this regard. The Director CDL also confirmed vide reply dated 23-10-2014 that the sample was sent to the Lab by ADC Karachi with Form-4 on 20-01-2014. However the stance of ADC regarding sending Board’s portion was not correct as neither the Board’s portions of the samples nor Memorandum bearing No.UL-01-03/2014-ADC(K) Export dated 20-01-2014 was not received in the Directorate of QA since January 2014 to 31-10-2014. As per communication made by the ADC, it is very clear that the mandatory provision of Section 19(3) of the Drugs Act 1976, and rules framed there under was not followed. So the ADC was asked again as why the Board’s portion was not forwarded as per above stated mandatory provision of the law

The ADC in response to this office letter dated 17-10-2014 sent retaining sample of the drug under reference and stated that beside all misunderstanding and minor error of lower staff, I am again sending the retaining sample of aforesaid batch which was available in her custody. The view point of the ADC Karachi regarding sending Boards portion is not correct as no sample as per memorandum bearing No. UL 01-03/2014-ADC (K)-Export date 20-01-2014 has been received in Directorate of QA/LT Islamabad. The retaining sample sent by the ADC afterwards and received by QC Section on 31-10-2014 is without memorandum and can not be entertained as the same has not been forwarded with in mandatory 07 days time period as prescribed under Section 19(3)(ii) of Drugs Act 1976.

The Director CDL was asked to comment on the delayed analysis of the sample of the drug under reference sent/delivered to the Lab on 20-01-2014 as same should have been analysed/reported within 60 days of the receipt of sample as required under Section 22(2) of


Drugs Act 1976. No extension in the testing period was sought from the competent authority as per record of Directorate of QA/LT. The test report of the samples was issued on 14-07-2014 i.e. 05 months and 25 days after the receipt of sample by the Lab. It has also been stated that samples from export consignment are liable to be charged for testing fee by CDL for test analysis. It was also submitted that the date of receipt of testing fee is considered as the date of receipt of sample as per policy framed after repeated observations by audit and public accounts committee of National Assembly on outstanding testing fee. In the instant case the relevant voucher of testing fee for the sample was submitted to CDL on 12-06-2014 therefore the same was mentioned as the date of receipt of sample. It has been further stated that CDL tested and reported the drugs sample under reference with in only one weak after receiving the sample with complete legal formalities.

The Director CDL Karachi has not adhered to the above stated mandatory provision of Section 22(2) of Drugs Act 1976.

In the instant case the Board portion has not been received as required under Section 19(3) (ii) of the Drugs Act 1976 and the CDL test report has been issued after the laps of mandatory time period. In view of above, it was therefore, proposed to place the case before the Registration Board for consideration, direction and decision as the firm has challenged the CDL test report under Section 22(4) of the Drugs Act 1976. The Board may also inquire further from Director CDL Karachi and ADC Karachi on the issue.

The worthy Chairman Registration Board directed to bring the case before the Board for discussion.

The case was placed before Drug Registration Board in its 248th meeting held on 19th

March 2015 but due to paucity of time the Board deferred the case till next meeting of the Registration Board. The case was again submitted to the Board in its 249 th meeting held on 19-05-2015 for consideration and further directions in the matter.

Decision of 249 th meeting :

Due to paucity of time the Board deferred the case till next meeting of the Registration Board

Decision: Registration Board deliberated the matter and advised QA&LT Division to

investigate the case and take appropriate action and inform Registration Board accordingly.


Item no.V: Additional cases.

Case No.01: Writ Petition No.758/2015 and 4174/2015, Islamabad High Court.

Registration Board in 259th meeting deliberated decision of Islamabad High Court,

Islamabad in Writ Petition No.758/2015 and 4174/2015. Members were of the view that matter is

required to be discussed in detail with representative of M/o Law and Justice (Member

Registration Board) for opinion regarding registration of drug. Accordingly, decision in subject

petitions was deliberated in presence of representative of M/o Law and Justice. Registration

Board) was of the view that both petitions No. 758/2015 and 4174/2015 filed by the petitioner

M/s Everest Pharmaceuticals, Islamabad were disposed of by Islamabad High Court, Islamabad

vide a single order. The petitioner sought relief on the following five points: -

i. Declare that the drug Everlong is validly registered. ii. The withdrawal of the registration of tablet Everlong may be declared as illegal and

without lawful authority. iii. That the inspection of the premises, sealing of the tablet section of the premises/factory

be declared as without lawful authority and of no legal effect. iv. That registration of FIR No. 12/2015 be declared as without lawful authority and of no

legal effect. v. The Federal Investigation Agency be directed not to harass the petitioner or its staff.

Vide para 10 of the order, the Islamabad High Court has quashed the F.I.R’s, whereas

regards the withdrawal of registration, the Islamabad High Court has declared this writ petition

as infructuous on the ground that the matter of illegal withdrawal of registration is pending

before Lahore High Court vide writ petition No. 3200/2015.

In other words, the Islamabad High Court has granted relief to the petitioner on clauses (iv) & (v) of the prayer and has left the decision on clauses (i), (ii) & (iii) upon Lahore High Court.

The Registration Board in 260th meeting has decided to convey the relevant

quarters of DRAP to vigorously persue the case in Lahore High Court.


Case No.02: Deferred Case in 258th RB Meeting ZINNIA F (Levonorgestrel and Ethinylestradiol Tables with Ferrous Fumarate Tablets) of M/s Hakimsons (Impex) Private Limited, Karachi

Sr. No



Type of Form


Fee submitted




Decision in 258th

meeting

1. M/s Hakimsons (Impex) Private Limited, Karachi

M/s Famy Care Limited Plot No. 1606-1609, G.I.D.C SARIGAM 396155, Dist. VALSAD, GUJRAT, INDIA.

ZINNIA F(Levonorgestrel and Ethinylestradiol Tables with Ferrous Fumarate Tablets)

Strength of active ingredient:Label Claim:Each Sugar coated white tablet contains:Levonorgestrel Ph. Eur……..150mcgEthinylestradiol Ph. Eur……..30 mcgFerrous Fumarate TabletsEach Sugar coated Brown tablet contains:Ferrous fumarate


Fee deposited: Rs. 100000/- dated 04-9-2014 vide challan no. 0017217.

For UNFPA/ USAID not for market.

Combi pack of 21 tablets of Levonorgestrel & ethinylestradiol & 7 tablets of ferrous fumarate

Legalized CoPP dated 23-05-2014Legalized GMP Certificate No. 1403070 dated 05-3-2014

Free Sale Certificate No. ACV/Certi/ Famy Care/ 2592/14 dated 21-4-2014

Deferred for expert opinion by following experts and valid legalized CoPP:

a. Brig ® Muzamil Hussain Najmi Member Registration Board

b. Brig.Amir Ikram, AFIP, Rawalpindi.

c. Dr, Masud-ur- Rehman, DDG, DRAP


BP………75 mcg(Equivalent to Ferrous iron…24.375mg)

Pharmacological group:Hormonal Contraceptives.ATC Classification: G03AA07.

It is submitted that in the 258th meeting of Registration Board following of the experts of the decided by the Board.

1. Prof Dr. Sayeda Batool, MCH, PIMS Islamabad.2. Col.Dr. Abeera Ch. MH, Rawalpindi.3. Prof Dr. Nasira , PIMS, Islamabad

The above experts were also mentioned in the final draft minutes of 258 th RB communicated to Secretary, Registration Board. However they were in advertently replaced by the experts as mentioned in the last column of the agenda item and also in the decision of the Board.

Decision: Registration Board approved following relevant experts :a. Prof Dr. Sayeda Batool, MCH, PIMS Islamabad.b. Col.Dr. Abeera Ch. MH, Rawalpindi.c. Prof Dr. Nasira , PIMS, Islamabad

Registration Board deferred rest of agenda due to paucity of time.

Meeting ended with a vote of thanks to and from the chair.

End of Document

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