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Global Generic Product Directory Edition 3, 2011

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Global Generic

Product DirectoryEdition 3, 2011

This is the 3rd edition of the

Global Generic Product DirectoryAlthough not quite as ground breaking as the first edition, this one has MORE products, MORE developers and generated MORE excitement.

It is generally considered better than the first, which is great, as that is what we planned. If you have ideas on how we can keep improving our beloveddirectory, please do let us know.

The business process is now even simpler:

Genericlicensing Limited has been set up to help you do more business, more effectively.We want you to have access to all the product data you need to license more products; that is why we are dedicated to keeping our database updatedand finding new developers you might be interested in working with.

We want to be the first place you turn to when you think about a new productWe know you are a demanding user, so we're seeking new types and sources of data to add even more depth to our offering. We don't want you goanywhere else; that keeps us on our toes.

Enjoy the 3rd edition, we hope you will love, cherish and share it (ie tell other people about it!)

We believe in data; you can believe in us.

Asa CoxFounder, Genericlicensing [email protected] skype: asa_cox

Legal: All the information contained in the directory has been provided by manufacturers and developers in good faith; Genericlicensing Limited cannot therefore guarantee the accuracy ofthe data. Any consequential loss cannot be accepted as a result of any business conducted with companies listed or their products.

Find a productyou like in thedirectory

Go online towww.genericlicensing.com

Make contact with the developer

ContentsCOMPANIESlisted alphabetically (then by product)

Ache - Auro ........................ 276 - 301

Bata - Bors ........................ 306 - 347

Cadi - Cosc ........................ 351 - 372

Demo - Dyna ........................ 375 - 380

Efar - Euro ........................ 384 - 392

Fada - Frat ........................ 398 - 414

Gale - Grup ........................ 416 - 428

Hame - Herm ........................ 428 - 436

IND - Jubi ........................ 437 - 448

Kent - KRKA ........................ 450 - 461

Labo - Lupi ........................ 465 - 470

Neog - Orch ........................ 474 - 486

PH&T - Prol ........................ 486 - 496

Rafa - Rusa ........................ 499 - 504

Sage - SunP ........................ 505 - 515

Taro - Venu ........................ 517 - 526

Wock - YSP ........................ 526 - 532

PRODUCTSlisted alphabetically (then by company)

AS - Azt ........................ 2 – 31

Bac - But ........................ 31 – 41

Cab - Cyt ........................ 41 – 79

Dac - Dyd ........................ 79 – 99

Eba - Eze ........................ 99 – 107

Fam - Fus ........................ 108 – 121

Gab - Gri ........................ 122 – 132

Hal - Hyp ........................ 132 – 136

Iba - Ive ........................ 136 – 147

Ket - Ket ........................ 147 – 148

LC - Lys ........................ 151 – 167

Mac - Myc ........................ 167 – 187

Nab - Nys ........................ 187 – 194

Oct - Ozy ........................ 194 – 206

Pac - Pyr ........................ 206 – 227

Que - Qui ........................ 227 – 230

Rab - Rub ........................ 230 – 241

SA - Sum ........................ 241 – 251

Tac - Tro ........................ 251 – 266

Ura - Zal ........................ 266 – 274

Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.

Listings By

PRODUCT

2

PRODUCTSGlobal Generic Product directory

IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)

Molecule Name Company Form Strength FormatDossier Status

Approved Country

Regulatory Status

A S acid Faromed Capsule - Pellets 500 mg IOR Ready Austria NRPAcarbose Batavia Tablet 50mg, 100mg CTD Ready IOR IORAcarbose Bioplus Tablet 25 mg, 50 mg, 100 mg IOR In-Dev N/A IORAcarbose Bluepharm Tablet 25 mg, 50 mg, 100 mg CTD Ready Portugal PLGAcarbose Helm Tablet 50 mg, 100 mg CTD Ready Germany NRPAcarbose IND Swift Tablet 25mg NTA In-Dev N/A IORAcarbose IND Swift Tablet 50mg NTA In-Dev N/A IORAcarbose Substipharm Tablet 50 mg, 100 mg CTD Ready France PLGAcarbose Tecnimede Tablet 50 mg, 100 mg CTD Ready Portugal PLGAcarbose YSP Tablet 25mg ANDA In-Dev N/A IORAcarbose YSP Tablet 50mg ANDA In-Dev N/A IORAcarbose YSP Tablet 100mg ANDA In-Dev N/A IORAcarbose YSP Tablet 50 mg CTD Ready Taiwan PLGAcarbose YSP Tablet 50mg NTA Ready Taiwan ApprovedAcebrophylline Ache Laboratorios Solution - Oral 5 mg/ml, 10 mg/ml IOR Ready Brasil ApprovedAcebrophylline Eurofarma Syrup 120 ml IOR Ready Brasil ApprovedAcebutolol Hamelnrds Tablet 200 mg, 400 mg CTD Ready Germany NRPAceclidine HCl Farmigea Drops - Eye 2% ( 10 ml) CTD Ready Italy PLGAceclidine HCl + Timolol Farmigea Drops - Eye 0.1% + 0.25% (10 ml) CTD Ready Italy PLGAceclofenac Anglo-French Drugs

& Industries LtdTablet 100 mg IOR Ready India Approved

Aceclofenac Astron Tablet - Film coated 100 mg CTD Ready Spain PLGAceclofenac Batavia Tablet 100mg CTD Ready IOR IORAceclofenac Bioplus Tablet 100 mg IOR In-Dev N/A IORAceclofenac Chhikara Pharma Tablet 100 mg NTA Ready INDIA ApprovedAceclofenac Dynamic Lifecare Tablet 200 mg IOR Ready India ApprovedAceclofenac Eurofarma Gel - Topical 30 mg IOR Ready Brasil ApprovedAceclofenac Eurofarma Tablet 100 mg IOR Ready Brasil ApprovedAceclofenac SuanFarma Tablet 100 mg IOR Ready Spain PLGAceclofenac Substipharm Tablet 100 mg CTD Ready France PLG

because timing is everythingWe target our goals.

target our drugs. time our delivery…

For more information please visit www.dexcel.com Contact: [email protected], [email protected]

Research:groups of patents.Development: Approximately 50 products registered; about 20 further in development.Capacity: 3 manufacturing facilities – cutting-edge, computer-controlled manufacturing technology – including electronic batch recording.Quality: and

transfer and inventory coverage.Responsiveness: Global supply chain management services. Marketing/ Distribution: Major generic player in UK and Israel; fully geared up to win tenders in Germany. Presence in several more markets worldwide via distribution partners.

Interested in: Contract manufacturing Contract development/ Co-development Out-licencing In-licencing Distribution EU-re-analyses/ release

• 20 Top Company Profiles• All seeking international partners

• No introduction fee'[email protected]

GROW YOUR BUSINESS!LICENSE OTC'S OR BIOSIMILARS

Wockhardt UK is a diverse pharmaceutical business, created from the merger of CP

Pharmaceuticals and The Wallis Laboratory. We are a major supplier of healthcare

products to the Retail Pharmacy, Hospital and Grocery sectors. With thriving Export

and Contract Manufacturing Divisions also in place, this is an exciting time for

Wockhardt UK.

Contact: Ashish Kakabalia - Head of Pharmacy, GSL & Business Development

email: [email protected]

Telephone: +44 (0) 1978 661261

COmpaNY Name

Wockhardt UK Ltd

CiTY

Wrexham

COUNTRY

UK

FEATURED COMPANYGLOBAL GENERIC PRODUCT DIRECTORY

Product Form Strength Format Country Status Reg

In-Dev/

Ready/App

1st

App Date

Reg

Date

Cilostazol

Cimetidine

Ciprofloxacin

Ciprofloxacin

Ciprofloxacin Lactate

Citalopram

Citalopram

Clarithromycin

Clarithromycin

Clopidrogel

Desloratadine

Desloratadine

Desloratadine

Diclofenac

Diclofenac

Diltiazem

Diltiazem HCl

Diosmin + Hesperidin

Domperidone

Donepezil

Donepezil

Doxazosin

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

In-Dev

Ready

Ready

Ready

App

Ready

App

Ready

App

Ready

Ready

In-Dev

In-Dev

Ready

Ready

App

Ready

App

Ready

UK

Portugal

Greece

UK

Greece

UK

Greece

UK

Greece

Portugal

Greece

DCP �

None

None

None

PL

None

PL

None

PL

None

None

None

None

None

None

PL

None

PL

None

Ready

Validation

Ready

Pilot Scale

BE Pend.

Status

Ready

Dec-09

Nov-08

Mar-08

Nov-08

Nov-08

Dec-09

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

50 mg, 100 mg

100 mg, 200 mg,

400 mg, 800 mg

250 mg, 500 mg, 750 mg

250 mg, 500 mg, 750 mg

250 mg, 500 mg

10 mg, 20 mg, 40 mg

20 mg

250 mg, 500 mg

250 mg, 500 mg

75 mg

5 mg

2.5 mg, 5 mg

5 mg

25 mg, 50 mg

75 mg, 100 mg

60 mg

180 mg

450 mg + 50 mg

10 mg

5 mg, 10 mg

5 mg, 10 mg

<2008

<2008

Oct-08

Oct-08

Feb-09SAMP

LE DAT

A ONLY

FEATURED COMPANYGLOBAL GENERIC PRODUCT DIRECTORY

A fast-growing multinational group, specialized in manufacturing and marketing of

generic, branded and licensed pharmaceutical products globally. Manufacturing

operations are located in Jordan, Algeria, Egypt, Germany, Italy, Portugal, Saudi

Arabia, Tunisia and USA. Active markets include MENA, USA and Europe. Profoundly

working on expanding to new regions such as Australasia and South America.

Contact: Contact Name

email: [email protected]

Telephone: Contact Telephone Number

COmpaNY Name

HikmaPharmaceutials

CiTY

Amman

COUNTRY

Jordan

Product Form Strength Format Country Status Reg

In-Dev/

Ready/App

1st

App Date

Reg

Date

Cilostazol

Cimetidine

Ciprofloxacin

Ciprofloxacin

Ciprofloxacin Lactate

Citalopram

Citalopram

Clarithromycin

Clarithromycin

Clopidrogel

Desloratadine

Desloratadine

Desloratadine

Diclofenac

Diclofenac

Diltiazem

Diltiazem HCl

Diosmin + Hesperidin

Domperidone

Donepezil

Donepezil

Doxazosin

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

Tab

In-Dev

Ready

Ready

Ready

App

Ready

App

Ready

App

Ready

Ready

In-Dev

In-Dev

Ready

Ready

App

Ready

App

Ready

UK

Portugal

Greece

UK

Greece

UK

Greece

UK

Greece

Portugal

Greece

DCP �

None

None

None

PL

None

PL

None

PL

None

None

None

None

None

None

PL

None

PL

None

Ready

Validation

Ready

Pilot Scale

BE Pend.

Status

Ready

Dec-09

Nov-08

Mar-08

Nov-08

Nov-08

Dec-09

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

CTD

50 mg, 100 mg

100 mg, 200 mg,

400 mg, 800 mg

250 mg, 500 mg, 750 mg

250 mg, 500 mg, 750 mg

250 mg, 500 mg

10 mg, 20 mg, 40 mg

20 mg

250 mg, 500 mg

250 mg, 500 mg

75 mg

5 mg

2.5 mg, 5 mg

5 mg

25 mg, 50 mg

75 mg, 100 mg

60 mg

180 mg

450 mg + 50 mg

10 mg

5 mg, 10 mg

5 mg, 10 mg

<2008

<2008

Oct-08

Oct-08

Feb-09SAMP

LE DAT

A ONLY

Listings By

COMPANY

276

COMPANYGlobal Generic Product directory

IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)

Company Molecule Name Form Strength FormatDossier Status

Approved Country

Regulatory Status

Ache Laboratorios Acebrophylline Solution - Oral 5 mg/ml, 10 mg/ml IOR Ready Brasil ApprovedAche Laboratorios Adapalene Gel - Topical 1% (30 g) IOR Ready Brasil ApprovedAche Laboratorios Alprazolam Tablet 0.5 mg IOR Ready Brasil ApprovedAche Laboratorios Ambroxol Solution - Oral 3 mg/ml, 6 mg/ml IOR Ready Brasil ApprovedAche Laboratorios Amiloride + HCTZ Tablet 5 mg + 50 mg IOR Ready Brasil ApprovedAche Laboratorios Amiodarone Tablet 200 mg IOR Ready Brasil ApprovedAche Laboratorios Amlodipine Besilate Tablet 5 mg, 10 mg IOR Ready Brasil ApprovedAche Laboratorios Amoxicillin Solution - Oral 50 mg / 5 ml, 400 mg / 10 ml IOR Ready Brasil ApprovedAche Laboratorios Atenolol Tablet 25 mg, 50 mg, 100 mg IOR Ready Brasil ApprovedAche Laboratorios Atenolol + Chlorthalidone Tablet 50 mg + 12.5 mg, 100 mg + 50 mg IOR Ready Brasil ApprovedAche Laboratorios Brimonidine Solution -

Ophtalmic2 mg/ml IOR Ready Brasil Approved

Ache Laboratorios Bromazepam Tablet 3 mg, 6 mg IOR Ready Brasil ApprovedAche Laboratorios Bromopride Drops 4 mg/ml IOR Ready Brasil ApprovedAche Laboratorios Bromopride Solution - Oral 1 mg/ml IOR Ready Brasil ApprovedAche Laboratorios Captopril Tablet 25 mg, 50 mg IOR Ready Brasil ApprovedAche Laboratorios Carbamazepine Tablet 200 mg IOR Ready Brasil ApprovedAche Laboratorios Carbidopa + Levodopa Tablet 25 mg + 250 mg IOR Ready Brasil ApprovedAche Laboratorios Carbocisteine Solution - Oral 20 mg/ml, 50 mg/ml IOR Ready Brasil ApprovedAche Laboratorios Carvedilol Tablet 3.125 mg, 6.25 mg, 12.5 mg, 25 mg IOR Ready Brasil ApprovedAche Laboratorios Cefadroxil Monohydrate Solution - Oral 50 mg/ml, 100 mg/ml IOR Ready Brasil ApprovedAche Laboratorios Chlorthalidone + Atenolol Tablet 12.5 mg + 50 mg, 50 mg + 100 mg IOR Ready Brasil ApprovedAche Laboratorios Ciprofloxacin Tablet - Film coated 500 mg IOR Ready Brasil ApprovedAche Laboratorios Citalopram Tablet - Film coated 20 mg IOR Ready Brasil ApprovedAche Laboratorios Cyclobenzaprine Tablet 5 mg, 10 mg IOR Ready Brasil ApprovedAche Laboratorios Desonide Cream 5 mg/g (30 g) IOR Ready Brasil ApprovedAche Laboratorios Dexamethasone + Tobramycin Solution -

Ophtalmic1 mg + 3 mg / ml IOR Ready Brasil Approved

Ache Laboratorios Diclofenac Solution - Oral 15 mg/ml IOR Ready Brasil ApprovedAche Laboratorios Diclofenac Gel - Topical 10 mg/g IOR Ready Brasil Approved

Give us a brief >> We agree a list of companies & products >>

We get a licensing offer from them >> You take it from there

[email protected]

WE'LL DO THE WORK!TAKE THE EFFORT OUT OF IN-LICENSING

� Regulatory filings, variations and license maintenance

� Dossier creation, formatting and auditing (NTA, CTD, eCTD, ANDA)

� Manufacturing GMP inspection preparation

� Manufacturing technical transfers

� Formulation development projects

Europe – North America – AustralasiaExpertise is offered both in-house and through industry leading partners.

Talk to us about your technical service requirements today.

CALL +44 (0)870 [email protected]

Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.

Services Offered

© Copyright 2008-2011

Email: [email protected] or Phone: +44 8707524105