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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:

Environmental Regulations
Energy saving
1. Waste reduction
2. Environmental awareness
a. Employers
b. Shareholders/Suppliers
3. Tree plantation (on site/off site)
a. Number of trees
4. 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 Capacity
Dosage form Millions/Annum/Per shift
Capsules 225
vials 20
Tablet 48
Dry Syrup 06

Dosage Form Millions/Annum/Per Shift

Tablets 2000
Capsules 90
Injections(Ampoules) 30
Liquid Syrup(Bottles) 12

Dosage Form Millions/Annum/Per Shift

Tablets 750
Capsules 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:

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Raw material is procured from the following vendors.

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.

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11. Types of Dosage forms manufactured by Unichem Limited

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

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Cardiology

Product Composition
LOSAR Losartan
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/ Clopidogrel + Aspirin
FORTE
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

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C PRAM - S Escitalopram
DIPROEX Divalproex Sodium
MIRTADEP Mirtazapine
OXCAZO Oxcarbazepine
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 ® Hydroxy Progesterone Caproate
DEPOT
UNIPROGESTIN - M Micronised Progesterone
Cap

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

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 • Tap density tester
• Water activity measurement equipment
• Friabilator
• Disintegration tester
• Vernier caliper
• Manual capsule filling machine
• Multistem thermometere
• Kembert compression machine
• Thermo hygro clock

14. Process Flow sheets

Literature Survey

Product Specification

OK/
NOT
OK

Literature survey and

Competitor’s product
evaluation for the product

Compiled report of Literature

survey and Competitor product
evaluation

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Receipt of raw materials

Test and Analysis

License

OK/
Not OK

Requisition for
Active/Excipients/Packaging
materials to purchase department

Receipt of materials

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Analysis of Raw materials

Receipt of raw materials

OK/
NOT
OK

Sending samples for testing to

ARD

Receipt of Certificate of
analysis of raw materials
from ARD

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Preformulation Studies

COA of analysis of
Ingredients

OK/ Rejection of
NOT material
OK

Preformulation trials initiation Intimate Purchase

Department/Return of
material to the
manufacturer
Compiled
preformulation
analytical data from
ARD

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Finalization of formulation

Finalization data from

ARD

OK/
NOT
OK

Initiation of feasibility studies

Finalization of
formula

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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.

Recommended Methods for carrying out the destruction of rejects

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S.NO. TYPE OF REJECTS METHOD OF DESTRUCTION

1 Empty containers of bulk Ensure that the containers are empty. If

materials from stores necessary, rinse with water. Deface the
labels before disposal.
2 Powder from dust collection Slurry or make a solution in water or
systems any special solvent. Send slurry to
effluent treatment system.
3 Granules, powders, tablets, Slurry or make a solution in water or
capsules any special solvent. Send it to effluent
treatment system.
4 Syrups, liquids including Drain into the effluent treatment system
injectable preparations 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 Tablets/capsules to be recovered, if
empty packs permitted by SOP, by defoiling.
Rejected tablets/capsules to be
destroyed as per point no.3
8 Printed packaging components Destroy by incineration or by shredding
(labels, cartons. Foils, leaflets)

16. Training Facilities in the Industry:

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-

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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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