Professional Documents
Culture Documents
Introduction
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.
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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:
Quality Objectives:
Environmental Policy:
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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 Specialities
• Unisearch
• Neu Foreva
UNICHEM PHARMA:
UNICHEMSPECIALITIES
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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
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.
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.
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:
The Goa plant is exclusively dedicated to the manufacturing of non-antibiotic oral solid
dosage forms.
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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.
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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
• Anti-diabetics
• Cardiovascular
• Pain &Anti-inflammation
• Dermatology
• Gynecology
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• Internal Medicine
• Pediatrics
• Anti Infective
• Alimentary
• Rejuvenators
• Anti Allergic
• Haematinics
• Vaccines
• Hormones
Unichem formulation research is carried out at its two top class research
centers:
Mumbai
Goa
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Raw material is procured from the following vendors.
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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
Anti Infectives
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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
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
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
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
• 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
Literature Survey
Product Specification
OK/
NOT
OK
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Receipt of raw materials
OK/
Not OK
Requisition for
Active/Excipients/Packaging
materials to purchase department
Receipt of materials
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Analysis of Raw materials
OK/
NOT
OK
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
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Finalization of formulation
OK/
NOT
OK
Finalization of
formula
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15. Handling 0f Rejects/ Scrap
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S.NO. TYPE OF REJECTS METHOD OF DESTRUCTION
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
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