1. Introduction

The orientation program was carried out at Pharma Technology Development,

Unichem Bhavan, Prabhat Estate, S.V.Road, Jogeshwari (West), MUMBAI -400102

Head Office: Unichem Laboratories Ltd., Unichem Bhavan,Prabhat Estate, S.V.Road,

Jogeshwari(West),MUMBAI-400102

2.Company Profile

Unichem brings to the customer a blend of modern-day research and nearly six

decades of rich experience in the Indian pharmaceuticals industry. The Company was

promoted by the late Mr. Amrut Mody, a pioneer in the Indian pharmaceuticals business.

Even though formulations account for a significant portion of Unichem's revenues,

the Company also manufactures active pharmaceutical ingredients (API or bulk actives).

The Company has prudently addressed relevant and growing therapeutic areas like gastro-

intestinal, cardiovasculars, diabetes, psychaitry, neurology, anti-bacterials, anti-infectives

and pain management, among others.

Unichem is headquartered in Mumbai with four manufacturing locations in Roha

(Maharashtra), Goa, Ghaziabad (Uttar Pradesh) and Baddi (Himachal Pradesh). The

Company's facilities enjoy credible certifications: for instance, the Goa plant has been

approved by UK MHRA (earlier MCA), MCC (South Africa), WHO (Geneva) and TGA

(Australia). The Baddi plant has been approved by UK MHRA and MCC (South Africa).

The Company has received ISO 9001:2000 for all its plants and corporate office. Similarly

the Company has received ISO14001:1996 certificates for its formulation plants ( Goa,

Ghaziabad and Baddi) and Corporate Office at Mumbai.

As a future-focused initiative. Unichem has expanded its Research and

Development facility in Jogeshwari (Mumbai) to spearhead research in Novel Drug

Delivery Systems (NDDS) and develop non-infringing routes for the manufacture of

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products directed at the regulated markets. The Company has also funded a collaborative

research with the Indian Institute of Sciences, Bangalore.

3. Company Policy

Quality Policy:

To manufacture and market pharmaceutical formulations and Active

Pharmaceutical Ingredients of requisite standards to comply with customer needs, enhance

customer satisfaction and continuously improve the effectiveness of QMS.

This shall be achieved by implementing the practices in processes and systems,

updating and conforming to applicable regulatory requirements continuous and dynamic

improvements in quality of products and services.

Quality Objectives:

International Regulatory approvals

MCA, TGA & MCC approvals for formulation plants

USFDA approval for minimum 3 products

Capacity utilization

To achieve 95% of the production plan

Customer satisfaction

To achieve 90% customer satisfaction

Reduction in customer complaints

Competency development

To develop and enhance competence of personnel in identified skills

Productivity improvements

To increase production by 5% in chosen areas

Environmental Policy:

To manufacture and market pharmaceutical formulations and Active

Pharmaceutical Ingredients of requisite standards to comply with customer needs, enhance

customer satisfaction and continuously improve the effectiveness of the EMS.

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We shall be a responsible care company for the environment by promoting

environment, complying applicable environmental regulations and prevention of pollution

in all our operations, including planning for energy saving and conservation of natural

resources.

Environmental Objectives:

1. Environmental Regulations

2. Energy saving

3. Waste reduction

4. Environmental awareness

a. Employers

b. Shareholders/Suppliers

5. Tree plantation (on site/off site)

a. Number of trees

6. Use of Environment Friendly materials

4. P.T.D

Self contained State of the Art product development laboratory meeting cGMP

requirements to undertake formulation engineering of per oral dosage forms (viz.

tablets, capsules, syrups, suspensions, dry syrups), parenterals, dermatologicals,

powders, modified release deliveries and opthalmics.

Pre-formulation laboratory to conduct drug-excipient compatibility study, product-

package integrity testing, stability study as per ICH requirements, physical

characterization of API and powder mechanics.

Pilot plant facilities for manufacture of pilot and bio-batches for tablets and

capsules.

The pharma technology development department caters to versatile product

development including new drugs, herbal extracts and products of natural origin,

probiotics, prebiotics, food supplements etc.

Independent laboratory with separate HVAC for product development for beta

lactam antibiotics dosage forms viz. tablets, capsules, dry syrups and parenterals.

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A team of dedicated, competent and post-graduates/doctorate pharmaceutical

technologists.

Capacity of development of novel drug delivery systems, platform therapeutic

systems and other novel technologies.

In-house patent cell which comprises of scientists and registered patent attorney

and conducts patent research, reviews, patent filings and patent infringement

detailing.

Contract research being conducted for generic product development for regulated

markets such as US, Canada, Europe etc.

Post in Research and Development - Formulations

Vice-President / General Manager

Deputy General Manager

Manager/Tech Transfer Manager

Deputy Manager

Assistant Manager

Research Executive

Research Associate

Trainee

5. Global Footprint

Unichem has built a visible and growing branded generic formulation presence

across at its market in Asia and Africa and CIS countries .A number of its products

have emerged as brand leader in India and these markets. The company also

incorporated subsidiaries in the regulated markets of US and EU and is marking

significant investment to build a strong API and generic formulation business in these

markets. In all, the company operates in market for formulation and also supplies APIs

to market globally.Making significant investments to build a strong API and generic

formulations business in these markets.

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DOMESTIC PHARMACEUTICALS

Unichem’s domestic pharmaceutical market presence is powered through the three

major marketing Divisions.

Unichem Pharma

Unichem Specialities

Unisearch

Neu Foreva

UNICHEM PHARMA:

Unichem Pharma is the flagship division of Unichem Laboratories. The division

has a diverse portfolio of over 25 brands in the day therapy areas of Pain management,

Anti infectives, Anti allergics, Digestives and Nutritionals. The division has attained

leadership in key segments of Cephalosporins and Anti-allergics with brands that have

been launched in the past 3 to 4 years. Key among these are Sefdin a brand of Cerfdinir

and Lezyncet the leading brand by volumes in the Levocetrizine market. In fact many

brands of Unichem Pharma feature among the top three brands of the respective segment

and three of the brands rank among the top 300 in the Indian Pharmaceutical industry.

UNICHEMSPECIALITIES

Unichem Specialities is the newest addition to Unichem's many divisions in an

endeavour to service more and more customers with quality products and services

launched in January 2006 , Unichem Specialities has a total field force of 250 people all

over India. Their core customers are Orthopaedicians , Surgeons , Gastroenterologists ,

Physicians , Paediatricians and Intensivists and will reach close to 22,500 doctors all over

India

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The philosophy of the division is that each one of us are a Step Ahead in whatever we

do. Each and every member of Team Unichem Specialities aims to be a step ahead in

product knowledge , building relationships with customers , competition and in surpassing

targets quarter after quarter.

UnichemSpecialities

Unichem Specialities is the newest addition to Unichem's many divisions in an

endeavour to service more and more customers with quality products and services.

Launched in January 2006 , Unichem Specialities has a total field force of 250 people all

over India. Their core customers are Orthopaedicians , Surgeons , Gastroenterologists ,

Physicians , Paediatricians and Intensivists and will reach close to 22,500 doctors all over

India

The philosophy of the division is that each one of us are a Step Ahead in whatever we do.

Each and every member of Team Unichem Specialities aims to be a step ahead in product

knowledge , building relationships with customers , competition and in surpassing targets

quarter after quarter.

The top Branded generics of the Division are:

Product Composition

LOSAR Combinations Losartan

TRIKA Alprazolam

CORVADIL Combinations Amlodipine

TG - TOR Atorvastatin

CLODREL Combinations Clopidogrel

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NeuForeva

Neu Foreva is a specialty division catering to the areas of Women's healthcare and

Neuropsychiatry.

After the launch in July 1999, as Foreva and establishing its presence in the area of

Women healthcare, the Business division was renamed as Neu Foreva in 2002.

The top Branded generics of the Division are:

Product Composition

SERTA Sertraline

TRIKA - SR Alprazolam SR

SULBACIN Combinations Ampicillin + Salbactum

UNIPROGESTIN Hydroxy Progesterone Caproate

UNIPROGESTIN M Micronised Progesterone

TRIKA PLUS / FORTE Alprazolam SR + Sertraline

6. Manufacturing Capabilities

Over the years,Unichem has strengthened its integration across the pharmaceutics

value chain through operations across its various manufacturing plants:

Formulation: Baddi, Goa, Gaziabad API:Roha, Pithampur

The Goa plant is exclusively dedicated to the manufacturing of non-antibiotic oral solid

dosage forms.

Goa plant consistently meets Cgmp guidelines and WHO specifications.

Environmental regulations and safety requirements are also rigorously complied with.

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In the manufacturing area,all the processing rooms have their own dedicated air

handling unit to prevent cross contamination.Each processing area has a total

environmental control and a record of temperature,humidity and pressure

gradient is maintained and monitored through a sophisticated computer program.It has an

ultrafiltered recirculating loop purified water system meeting International Standards.

The highly automated PLC controlled high speed machines make it possible to take

up manufacturing of more sophisticated products with assured quality

Standards. This Plant also supports the International Business Operations

and enables the company to meet the international standards of Good Manufacturing

Practices.

The world class Baddi plant house the manufacturing facility for different

formulations of Beta Lactam range of antibiotics.

Ghaziabad plantds was founded in the year 1969 as a multi-product pharmaceutical plant.

In the year 2003,the manufacturing facility has been completely upgraded to meet

the International Standards for manufacturing of pharmaceutical formulations.

7. REGULATORY APPROVALS

The Ghaziabad Plant is approved by WHO and many other Regulatory approvals

on the anvil.

The Ghaziabad Plant is approved WHO,ANIVSA(BRAZIL) and many other

Regulatory approvals on the anvil.

Approved by World Premier Regulatory Bodies-WHO,MCC-South Africa ,MHRA-

UK.

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The Goa Plant is approved by Food and Drug Administration(US FDA),Medicines

Control Council(MCC)-South Africa, Medicines & Health care products Regulatory

Agency(MHRA)-UK., Therapeutic Goods Administration –Australia, ANVISA-Brazil,

WHO(Geneva)and by many other Regulatory authorities.

Installed CapacityDosage form Millions/Annum/Per shiftCapsules 225vials 20Tablet 48Dry Syrup 06

Dosage Form Millions/Annum/Per ShiftTablets 2000Capsules 90Injections(Ampoules) 30Liquid Syrup(Bottles) 12

Dosage Form Millions/Annum/Per ShiftTablets 750Capsules 150

8. Research and Development

Anti-diabetics

Respiratory Tract Infection

Cardiovascular

Pain &Anti-inflammation

Dermatology

Gynecology

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Internal Medicine

Pediatrics

Anti Infective

Psychiatry & Neurology

Nutrients, Minerals & Antioxidants

Alimentary

Rejuvenators

Anti Allergic

Haematinics

Vaccines

Hormones

Unichem formulation research is carried out at its two top class research centers:

Mumbai

Goa

9. Source of Raw Material:

Raw material is procured from the following vendors.

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Associated capsules P. Ltd

E Merck

Aurobindo Pharma Ltd

Enar Chemie P. Ltd

BASF

GM Chemicals

Capsugel

IPCA Laboratories Ltd.

Chemplast Sanwar Ltd

ISP Technology

Colorcon Asia Pvt Ltd

Lactose (India) Ltd.

Degussa

Roha Dye Chem Pvt Ltd.

DMV, Holland

Shinetsu, Japan

DMV, International

Sterling Biotech Ltd.

Dow Chemicals

Universal Capsules P. Ltd.

10. Source of Water and Power

Raw water supplies from Maharashtra Industrial development Corporation. It is

collected underground tank capacity of 50000 liters then water is lifted to 10000 liter

overhead tanks, from which raw water is supplied to user points in laboratory. This

water is treated to Millipore water system, which is used in R&D-F. Also small

Demineralised water plant is provided for other purposes. Power is supplied from

Maharashtra State Electric board, Mumbai.

11. Types of Dosage forms manufactured by Unichem Limited

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1. Solids : a) Tablets

b) Capsules

2. Semisolids: a) Ointments

b) Creams

3. Liquids : a) Solutions

b) Syrups

c) Suspensions

d) Injections

4. Miscellaneous : Novel Drug Delivery Systems

12. List of Products manufactured by Unichem Laboratories ltd.

Anti Infectives

AMPOXIN Ampicillin + Cloxacillin

AMPOXIN LB Ampicillin + Cloxacillin + Lactic Acid Bacillus

FIXX Cefixime

SULBACIN Ampicillin + Salbactum

FLOSPAR Sparfloxacin

BICLAR Clarithromycin

SEFDIN Cefdinir

LINOX Linezolid

TAGERA FORTE Secnidazole

UNICARBZAN Diethylcarbamazine citrate + Chlorpheniramine maleate

ANTICOX II Rifampicin + Isoniazid

ANTICOX 3 Rifampicin + Isoniazid + Ethambutol

ANTICOX 4 Rifampicin + Isoniazid + Pyrazinamide + Ethambutol

ANTICOX Z Rifampicin + Isoniazid + Pyrazinamide

Cardiology

Product Composition

LOSAR Losartan

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LOSAR H Losartan + Hydrochlorothiazide

CORVADIL Amlodipine

CORVADIL A Amlodipine + Atenolol

TG-TOR Atorvastatin

LOPRIN Aspirin

LOPRIN DS Aspirin 162.5 mg

CLODREL Clopidogrel

CORBIS Bisoprolol

ANGITRIT Isosorbide-5-Mononitrate

NORMACE Enalapril

NORMACE D Enalapril + Hydrochlorothiazide

ARKAMIN Clonidine

ARKAMIN H Clonidine + Hydrochlorothiazide

UNIWARFIN Warfarin

LORAM Losartan + Ramipril

LORAM H Losartan + Ramipril + Hydrochlorothiazide

CLODREL PLUS/ FORTE

Clopidogrel + Aspirin

BETANIF Nifedipine + Atenolol

Psychiatry & Neurology

Product Composition

TRIKA Alpazolam

TRIKA FORTE Alprazolam SR + Sertraline

TRIKA - SR Alprazolam SR

TRIKA PLUS Alprazolam SR + Sertraline

SERTA Sertraline

ZYPINE Olanzepine

TRIZAC Fluoxetine

C PRAM Citalopram

C PRAM - S Escitalopram

DIPROEX Divalproex Sodium

MIRTADEP Mirtazapine

OXCAZO Oxcarbazepine

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ZISPER Resperidone

ZICAM Clonazepam

Musculoskeletal & Pain

Product Composition

PRONIM Nimesulide

ROFF Rofecoxib

ROFF BCD Rofecoxib in BCD

CELIB Celecoxib

M-CAM Meloxicam

ZULU Tizanidine HCL + Nimesulide

DOMADOL Tramadol

NORPHIN Buprenorphin

VALCOX Valdecoxib

VALCOX INJ. Parecoxib

AROFF Aceclofenac

AROFF PLUS Aceclofenac + Paracetamol

AROFF SR Aceclofenac

Nutrients, Minerals & Antioxidants

Product Composition

VIZYLAC Lactobacillus sporogenes + Thiamine + Riboflavin + Pyridoxine + Nicotinamide + Folic Acid + D-panthenol

NUTREVA Isolated Soya Protein + Fat + Carbohydrate + Energy + Vit A + Vit B1 + Vit B2 + Vit B6 + Vit B12 + Vit C + Vit D3 + Vit E + Vit K + Niacinamide + Folic Acid + Calcium Panthothenate + Biotin + Calcium + Copper + Iron + Magnesium + Manganese + Phosphorus + Pottasium + Zinc

EVACAL Calcium Citrate + Vit D3 + Magnesium

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Alimentary

Product Composition

UNI-ENZYME Papain + Fungal Diastase + Nicotinamide + Simethicone + Activated Charcoal

LANPRO Lansoprazole

IZRA Esomeprazole

Rejuvenators

Product Composition

TRINERGIC Ginseng + Vit B1 + Vit B6 + Vit B12 + Vit E + Zinc Sulphate

Anti Allergic

Product Composition

LE ZYNCET Levocetirizine

ZYNCET Cetirizine

ZYNCET D Cetirizine + Pseudoephedrine

Anti Diabetic

Product Composition

G-TASE Pioglitazone

G-TASE M Pioglitazone + Extended Release Metformin

Haematinics

Product Composition

FEROLUV Carbonyl Iron

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Hormones

Product Composition

DUBOGEN Norethinosterone

UNIPROGESTIN ® 50 Progesterone

UNIPROGESTIN ® DEPOT

Hydroxy Progesterone Caproate

UNIPROGESTIN - M Cap

Micronised Progesterone

Vaccines

Product Composition

UNIHEP - B Purified Hepatitis B surface Antigen

AMPOXIN Ampicillin + Cloxacillin

AMPOXIN LB

Ampicillin + Cloxacillin + Lactic Acid Bacillus

FIXX Cefixime

SULBACIN Ampicillin + Salbactum

FLOSPAR Sparfloxacin

BICLAR Clarithromycin

SEFDIN Cefdinir

LINOX Linezolid

TAGERA FORTE

Secnidazole

UNICARBZAN

Diethylcarbamazine citrate + Chlorpheniramine maleate

ANTICOX II Rifampicin + Isoniazid

ANTICOX 3 Rifampicin + Isoniazid + Ethambutol

ANTICOX 4 Rifampicin + Isoniazid + Pyrazinamide + Ethambutol

ANTICOX Z Rifampicin + Isoniazid + Pyrazinamide

13. List of instruments in Formulation R & D department

Octagonal blender

Multi Mill

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Fluidised Bed Drier

Rapid mixer Granulator

Planetary Mixer

Eight station rotatary compression machine

Dehumidifier

Spheronizer

Extruder

Electromagnetism induction sealing machine

Electromagnetic sieve shaker

Fast clean sonicator

Overhead stirrer

Microscope

Magnetic stirrer

Ph meter

Homogenizer

Hot plate

Electronic analytical balance

Weighing balance

Refrigerator

Drying oven

Elmac Packing Machine

Heat sealer

Hot air blower

Multi purpose equipment(blender, dry milling , wet milling and coating

Neo cota 15 A

Colloid mill

16 station rotary compression machine

Tablet hardness tester

LOD apparatus

Tap density tester

Water activity measurement equipment

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Friabilator

Disintegration tester

Vernier caliper

Manual capsule filling machine

Multistem thermometere

Kembert compression machine

Thermo hygro clock

14. Process Flow sheets

Literature Survey

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OK/ NOT OK

Literature survey and Competitor’s product

evaluation for the product

Compiled report of Literature survey and Competitor product

evaluation

Product Specification

Receipt of raw materials

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Test and Analysis License

OK/ Not OK

Requisition for Active/Excipients/Packaging

materials to purchase department

Receipt of materials

Analysis of Raw materials

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Receipt of raw materials

OK/ NOT OK

Sending samples for testing to ARD

Receipt of Certificate of analysis of raw materials

from ARD

Preformulation Studies

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COA of analysis of Ingredients

OK/ NOT OK

Preformulation trials initiation

Compiled preformulation

analytical data from ARD

Rejection of material

Intimate Purchase Department/Return of

material to the manufacturer

Finalization of formulation

15. Handling 0f Rejects/ Scrap

Handling of Rejects from production assumes great significance in the

pharmaceutical industry, since the use of incorrect destruction procedures have serious

adverse consequences for the manufacturing unit, particularly if such material finds its way

into the wrong hands. Therefore, it is of utmost importance that the inherent dangers of

mishandling of rejects/scraps is understood by all the persons concerned with production

operations.

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Finalization data from ARD

OK/ NOT OK

Initiation of feasibility studies

Finalization of formula

Recommended Methods for carrying out the destruction of rejects

S.NO. TYPE OF REJECTS METHOD OF DESTRUCTION

1 Empty containers of bulk

materials from stores

Ensure that the containers are empty. If

necessary, rinse with water. Deface the

labels before disposal.

2 Powder from dust collection

systems

Slurry or make a solution in water or

any special solvent. Send slurry to

effluent treatment system.

3 Granules, powders, tablets,

capsules

Slurry or make a solution in water or

any special solvent. Send it to effluent

treatment system.

4 Syrups, liquids including

injectable preparations

Drain into the effluent treatment system

with or without any special treatment.

5 Injectables in ampoules Manual or mechanical crushing to be

done after which the liquid residues

must be drained into the effluent

treatment system

6 Injectables in vials Vials to be unsealed and crushed (same

as in case of ampoules)

7 Strips/blister packs including

empty packs

Tablets/capsules to be recovered, if

permitted by SOP, by defoiling.

Rejected tablets/capsules to be

destroyed as per point no.3

8 Printed packaging components

(labels, cartons. Foils, leaflets)

Destroy by incineration or by shredding

16. Training Facilities in the Industry:

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Training needs of the personnel is identified based on General working observed with the

individual Desire shown by the individual for training in specific areas Results of Non-

Compliance observed during weekly audit.Internal training is imparted in a pre-defined

period every year.Training may be imparted by External Faculty Appropriate records of

the training is maintained in training register.

Internal training is given on following points:

CGMP procedures

Regulations and guidelines

DSM and ISO as per Departmental procedure.

Questionnaire is given to the candidates after the training, checked and evaluated.

Appropriate records of training given, along with questionnaire and answer sheets be

maintained in the training file.

17. Conclusion

The Pharma Technology development centre,Unichem Laboratories Ltd,is a well-

equiped company with all sophisticated modern equipments for the manufacturing of

tablets,cspsules and sterile products with an ideal location,layout and is strictly following

all the requirements of D&C actand current GMP norms. The company is controlled by a

well-organised governing body and it is found that the company motto is “Quality

Reliability”.Chase quality, quantitywill chase you”

This program exposed me to industrial environment and I observed the various

departments in Unichem Laboratories Ltd.,I also learnt about the skills that have to be

shown in an industry.It also helped me to choose my future project. In overall this program

enriched my general, academic and industrial awareness.

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