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Submitted to University of Rajasthan, Jaipur in partial fulfillment

of the requirements for for B.Sc.-M.Sc. Integrated Biotechnology

Submitted By
Shobha Singh

Seedling Institute
for Integrated Learning & Advanced Studies

This is to certify that Shobha Singh has successfully completed the industrial entitled
“ALEMBIC”. Her training report is satisfactory for submission in partial fulfillment of
the requirement for B.Sc. – M.Sc. (Biotechnology) Integrated of the University of the
Rajasthan, Jaipur .

Dated: Supervisor
Ms. Chandan Agarwal
(Lecturer, Life Sciences)

This is to certify that industrial report entitled “ALEMBIC” submitted by Shobha

Singh to the University of the Rajasthan, Jaipur in partial fulfillment of the
requirements for the degree of B.Sc. / M.Sc. (Biotechnology) Integrated has
been approved by committee after an Oral presentation/examination on the same
in collaboration with an External Examiner.

Supervisor External Examiner

Ms.Chandan Agarwal
(Lecturer, Life Sciences)

Director SIILAS
(Prof. D.S. Bhatia)

It is proud privilege me to express my profound regards and deep sense of gratitude to

Mr. Sandeep Bakshi (Chancellor of JNU), Mrs.Preeti Bakshi (Director of SIILAS), for
their constant encouragement &providing necessary help during the training.
I would like to thank Prof. D.S Bhatia, Head of the Department, Seedling Institute of
Integrated Learning and Advanced Studies, Jaipur, for giving me the opportunity to do
my summer training and gave me continuous instructions and encouragement. I cannot
refrain my humble thanks to my supervisor Ms. Chandan Agarwal for her kind help
and guidance.
It gives me immense pleasure and a sense of honour to express my feeling of gratitude to
all those who have helped me in successful completion of the present project. I shall
always be grateful to Mr. Chirayu Ramanbhai Amin, Chairman of ALEMBIC, and
SURAT for giving me an opportunity to undergo this summer training in their
organization and also for their immense contribution towards execution and completion
of this project.
I also thank Dr.Babubhai Rambhai Patel, Manager of quality control laboratory, for
his immense support and guidance without whom the project would not have been
accomplished. I wish to place on record my gratefulness with deep sense of gratitude to
my training supervisor Mr. Pranav Amin, Assistant Manager of quality control
laboratory, for his valuable advice and assistance, which were extremely helpful in
bringing out this training successfully.
I would like to thank Prof. D.S Bhatia, Head of the Department, Seedling Institute of
Integrated Learning and Advanced Studies, Jaipur, for giving me the opportunity to do
my summer training and gave me continuous instructions and encouragement. I cannot
refrain my humble thanks to my supervisor Ms. Chandan Agarwal for her kind help and
I am unable to express my indebtedness to my family and friends for their affection,
inspiration, encouragement and unparalleled sacrifice.

Dated: Shobha Singh

S.No. Contents Page No.










- LOCATION: Alembic Limited

Alembic Road,
Vadodara - 390 003.
- TYPE: Private


- Pvt. Ltd


Alembic has built a reputation for itself in the international pharmaceutical and fine
chemical arena, as a company focusing on delivering quality products & services that
conform to global norms. We understand specific needs of local markets of various
countries around the world. This allows us to collaborate through every stage of an
international product launch, which makes us the ideal business partner for any global
Vadodara, a cosmopolitan city in Gujarat State, is full of companies from diverse sectors
like Petrochemicals, textiles, chemicals, ceramics, glass and pottery.
Baroda enjoys a special place in the state of Gujarat. The first modern factory, which was
established in Baroda in the year 1907, was none other than Alembic Chemical Works
Ltd.The Baroda region is the largest beneficiary in the process of this industrialization.
Today, Baroda has lot of Industrial houses and top companies with their plants at Baroda.

Alembic started in 1907 & now it is Asia's most respected integrated pharmaceutical
company with manufacturing facilities in Baroda and Baddi, India with R&D facilities
spearheading landmark research in the areas of Chemistry, Microbiology, Pharmaceutical
Technology and Bio-Equivalence. Alembic has a turnover and growth rate that takes it
into the top bracket of Indian pharmaceutical companies with a series of brands among
the top five in their respective categories. Alembic is a certified ISO-9002, ISO-14001
and ISO 27001 company with manufacturing practices and facilities that conform to
WHO-GMP guidelines ensuing that every Alembic product meets the most stringent
quality standards. No wonder, then, Alembic can be found improving the quality of life in
over 75 countries around the world. Alembic is spreading its wings now to regulatory
markets both in respect of API and Formulation. The Department of Scientific and
Industrial Research (DSIR) of the Government of India recognize Alembic's Research
and Development Unit since 1975. Research and Development at Alembic is focused on
fermentation technology, strain improvement, industrial enzymes, non-infringing process
developments for API & intermediates, development of innovative formulations, NDDS.

The plant is divided in to following section:-

1) Process section.
a) Processing
b) Packing of drugs

2) Product section.
a) Antibiotic drugs Section
b) Antibacterial drugs Section

a) Quality control laboratory
b) Microbial laboratory




 Erythromycin was manufactured for the first time using expertise from Eli Lilli-

 Launched a brand of Erythromycin- "Althrocin" A landmark accomplishment of

manufacturing Kanamycin by fermentation. Alembic enjoys the status of being the
only basic manufacturer of this product in India, under the guidance of MEIJI SEIJA,

 Started the manufacturing of Erythromycin and its Derivatives.1975 R&D

facilities were approved by DSIR, GOI.

 From : 1907 TO 1960

Alembic Chemical Works Co. Ltd. is started, primarily engaged in the manufacture of
Tinctures and Alcohol at Baroda.
French Distillery plant for pharmaceutical purposes installed at Baroda.

 Process Development (Synthetic Drug Development)
One of ALEMBIC key objectives has been to develop indigenous processes for new
drugs introduced in the developed countries; produce and introduce them in India and
promptly supply them to non-regulatory markets.
Secondly, ALEMBIC emphasis will be on the development and commercialization of
generic Active Pharmaceutical Ingredients in line with domestic and international
regulatory and quality requirements. Our research efforts are geared to develop
innovative (patentable/non-infringing) and cost-effective process know-how for the
production of leading APIs and intermediates that are going off patent shortly.

 Fermentation Research
ALEMBIC goals in the area of fermentation research include productivity
improvement of strains by mutation; better maintenance and preservation of industrial
strains; and evaluation of cheap raw material towards the development of a cost-
effective process; indigenization of imported technology to suit local conditions
wherever necessary. Another important objective is to find more active and potent
microorganisms with anti-microbial activities from Indian soil.

 Formulations Development
The aim here is to devise formulations and dosage forms for new drugs to be
introduced and to make variants of particular dosage forms. Another objective is to
introduce drug combinations by understanding the mechanism of the interaction and
the combined effects in increasing intensity of response, in decreasing untoward
actions and in altering absorption. The therapeutic range covers Antibiotics,
Analgesics, Antihistamines, Antihypertensives, Antidiabetics, Vitamins,
Antioxidants, NSAIDs, and Psychotropic and Nutritional products.
 New Drug Delivery Systems
The development of new delivery systems like liposomes, nanoparticles and
controlled drug delivery systems to ensure better compliance, less total drug,
efficiency in treatment and economy.

-CADRE: Chairman
(Mr. Chirayu Ramanbhai Amin)

Managing Director
(Mr. Chirayu Ramanbhai Amin)

Whole time director
(Mr.Malika Chirayu Amin)

(Dr.Babubhai Rambhai Patel)

Director Precident
(Mr. Raj Kumar Bahati)

(Mr. Pranav Amin)



-LABOR: 750


-SECURITY: Private Aided

Drugs: A drug, is any chemical substance that, when absorbed into the body of a living

Uses: used in the treatment, cure, prevention or diagnosis of disease or used to otherwise
enhance physical or mental well-being, alters normal bodily function.


A. Antibiotics & Anti bacterials

B. Cough & Cold
C. Antihistamines
D. Oral Hypoglycemic
F. Herbals & Nutraceuticals
G. Others

A. Antibiotics & Anti bacterials

ALTHROCIN Each tablet contains: Erythromycin Estolate IP, Roxid Each film-coated
tablet contains: Roxithromycin 150 mg, Roxid M Each film-coated tablet contains:
Roxithromycin BP 150 mg, Ambroxol Hydrochloride 60 mg, Azithral Each film-coated
tablet contains Azithromycin Dihydrate USP equivalent to 250/500 mg of Azithromycin

B. Cough & Cold

Glycodin Cough Syrup Each 5 ml contains Terpin Hydrate USP 10 mg,

Dextromethorphan Hydrobromide IP 10 mg, Menthol IP 3.75 mg, Syrup Glycerin Base
q.s., Zeet Expectorant Each 5 ml contains Diphenhydramine Hydrochloride IP 8 mg,
Guaiphenesin IP 50 mg, Bromhexine Hydrochloride IP 4 mg, Ammonium Chloride IP
100 mg, Menthol IP 1 mg, in flavoured syrupy base, Zeet Expectorant Tablets Each
uncoated tablet contains Bromhexine Hydrochloride IP 8 mg, Phenylpropanolamine
Hydrochloride BP 25 mg, Wikoryl oral susp Each 5 ml contains Paracetamol 125 mg,
Phenylephrine Hcl 5 mg, Chlorpheniramine maleate 1mg, and flavoured syrup base Q.S

C. Antihistamines

Lormeg-D Tablets Each tablet contains Loratadine 10 mg, Lormeg syrup Each ml
contains 1 mg Loratadine, Laveta Each tablet contains Levocetirizine 5 mg.


Nimegesic Tablets Each uncoated tablet contains Nimesulide 100 mg, Nimegesic OD
Tablets Each tablet contains 200 mg Nimesulide; 100 mg in instant release form and 100
mg in Time Release form, Fortafan Each tablet contains 100 mg Aceclofenec,
Nimegesic P Each tablet contains Nimesulide 100 mg and Paracetamol 500 mg.

E. Oral Hypoglycemic

GLZ Plus Tablets Each film-coated tablet contains Gliclazide BP 80 mg, Metformin
Hydrochloride IP 500 mg, Pioride-1 Each tablet contains Pioglitazone 15 and glimipiride
1 mg, Glimser 1 Each uncoated bilayered tab contains Glimipiride 1 mg plus Metformin
hydrochloride IP SR 500 mg.

F. Herbals & Nutraceuticals

CALCY TABLETS 500 mg Each film coated tablets contains : Calcium Carbonate 1250
mg from an organic source (Oyster Shell) equivalent to 500 mg of Elemental Calcium,
Cholecalciferol (Vitamin D3 - Stabilised) 200 IU, Excipients q.s., Sharkoferrol Each 15
ml contains: Malt extract 4.52 gm, Ferric ammonium citrate 100 mg,Clcium Gluconate
360 mg,Cholecalciferol 400 IU, Niacinamide 45 mg, Folic acid 1.5 mg, Vitamin B12 15
mcg, Flavoured base., DiaxEach soft gelatin capsule contains:Beta Carotene
10.33mg,Methylcobalamin 500 mcg,Alpha Lipoic Acid 100 mg,Thiamine Hydrochloride
IP 2.0mg,Pyridoxine Hydreochloride IP 1.5 mg,Chromium Polynicotinate 200mcg,and
excipient q.s, Zocam Each tablet contains Alprazolam 0.25 and 0.5 mg, Elata Each tablet
contains Sucralose 6.50 mg, Zero Each tablet contains Sucralose 6.50 mg.


a. Microprocessor Controlled Pilot Fermentor
b. DCS Controlled Pilot Fermentor
c. Chemical Pilot Facility
d. High Pressure Reactor
e. Stability and validation cell

B. Analytical support & instrumentation

a. I.R. Spectrophotometer & autosampler
b. UV-Visible Spectrophotometer
c. Polarimeter
d. Ozonator
e. Auto Titrator
f. Particle size analyzer
g. Flash Chromatograph
h. Chromatotron
i. DSC
j. Ultra Centrifuge
k. Cyclotherm Shaker
l. Continuous Culture Apparatus
m. Auto Analyzer
n. Electronic Coulter Counter
o. Auto titroprocessor
p. Electronic microscope

Alembic considers the protection of the environment as direct responsibility and all
processes and technologies incorporate this feature. A clean and a green environment is
an absolute necessity and Alembic ensures this by using state-of-the-art Effluent
Treatment Plant for all the waste generated. Its sprawling green campus houses a large
percentage of employees.


(1) The immediate surroundings shall be free from refuse, rubbish, overgrown vegetation,
and waste materials, to prevent harborage of rodents, insects, and other vermin.

(2) A suitable drainage system shall be provided which will allow rapid drainage of all
water from plant buildings and driveways including surface water around the plant and
on the premises and all such water shall be disposed of in such a manner as to prevent an
environmental or health hazard.

Industry Description and Practices

The drug industry involves manufacturing of drugs such as antibiotics, antibacterials,

herbals and nutraceuticals.

Pollution Prevention and Control

Good pollution prevention practices in the drug industry include:
a. Reduction of product losses by better production control.
b. Use of disposable packaging (or bulk dispensing of milk) instead of bottles where
c. Optimization of use of water and cleaning chemicals; recirculation of cooling waters.
d. Segregation of effluents from sanitary installations, processing, and cooling
(including condensation) systems; this facilitates recycling of wastewater.
e. Use of condensates instead of fresh water for cleaning.
f. Use of high-pressure nozzles to minimize water usage.

Treatment Technologies
Pretreatment of effluents consists of screening, flow equalization, neutralization, and air
flotation; it is normally followed by biological treatment. If space is available, land
treatment or pond systems are potential treatment methods. Other possible biological
treatment systems include trickling filters, rotating biological contactors, and activated
sludge treatment. Pretreated dairy effluents can be discharged to a municipal sewerage
system, if capacity exists, with the approval of the relevant authority. Odor control by
ventilation and scrubbing may be required.
Monitoring and Reporting:-
Monitoring of the final effluent for the parameters listed above should be carried out at
least once per month or more frequently if the flows vary significantly. Monitoring data
should be analyzed and reviewed at regular intervals and compared with the operating
standards so that any necessary corrective actions can be taken. Records of monitoring
results should be kept in an acceptable format. The results should be reported to the
responsible authorities and relevant parties, as required.

Effluent Treatment Plant –

This plant is helpful in reducing operating costs and environmental pollution.

Most companies operate effluent treatment plants to reduce the potential for pollution of
receiving waters and to comply with discharge consent conditions. Effective management
and control of the processes used for effluent treatment will help you to:

 Reduce your operating costs and thus increase profits.

 Achieve more effective compliance with legislation.
 Improve your company's public image.
Pollution Prevention and Control

Every effort should be made to replace highly toxic and persistent ingredients with
degradable and less toxic ones.
Recommended pollution prevention measures are as follows:
a. Meter and control the quantities of active ingredients to minimize wastage.
b. Reuse by-products from the process as raw materials or as raw material substitutes in
other processes.
c. Recover solvents used in the process by distillation or other methods.
d. Give preference to the use of nonhalogenated solvents.
e. Use automated filling to minimize spillage.
f. Use “closed” feed systems into batch reactors.
g. Use equipment wash down waters and other process waters (such as leakages from
pump seals) as makeup solutions for subsequent batches.
h. Recirculate cooling water.
i. Use dedicated dust collectors to recycle recovered materials.
j. Vent equipment through a vapor recovery system.
k. Use loss-free vacuum pumps.
l. Return toxic materials packaging to the supplier for reuse, or incinerate/destroy it in
an environmentally acceptable manner.
m. Minimize storage time of off-specification products through regular reprocessing.
n. Find productive uses for off-specification products to avoid disposal problems.
o. Minimize raw material and product inventory to avoid degradation and wastage.
p. Use high-pressure hoses for equipment cleaning to reduce wastewater.
q. Provide storm water drainage and avoid contamination of storm water from process

Pollution Reduction Targets

Implementation of cleaner production processes and pollution prevention measures can
yield both economic and environmental benefits. Specific reduction targets for the
different processes have not been determined. In the absence of specific pollution
reduction targets, new plants should always achieve better than the industry averages
quoted in the section on Waste Characteristics. Vapor recovery systems should be
installed to control air emissions. Wastewaters and treated effluents should be recycled to
the extent feasible

Quality control (QC) is a procedure or set of procedures intended to ensure that a

manufactured product or performed service adheres to a defined set of quality criteria or
meets the requirements of the client or customer.

The quality control unit is defined as the Lab where testing of sample is done. The dairy
Quality Control Unit was established in 1908. Alembic have a modern, fully-equipped
laboratory. They conduct tests including biological, chemical, physical, labeling,
packaging, organic and inorganic contamination for drugs and Services are used by drug
manufacturers, associations, government and non government institutions.

Quality Control Tests-

1. Bioassay
2. Spore Count
3. Pilot Plant
4. High Performance Liquid Chromatography
5. Sugar determination-DNSA

1. Penicillin
(1) Bioassay

Standard solution of penicillin was diluted to 2ug/ml and 4ug/ml

Named as standard low (SL) and standard high (SH)

Unknown sample of penicillin was diluted to 2ug/ml and 4ug/ml

Named as unknown low (UL) and unknown high (UH)

Assay media was poured into Petri plate

150ul of SL, SH, UL, UH are poured in six wells

Allowed to diffuse for half an hour

Plates are incubated at 370 C for 7 hrs

Zone of inhibition of SL, SH, UL, UH was observed

W, V was calculated and potency was determined using formulae

Formula Used:
V= (UL+UH)-(SL+SH)
W= (UH+SH)-(UL+SL)
Potency =antilog (2+alog2)
Potency =percent*expected potency/100

(2) Spore Count

Culture content was added to sterile Tween 80 solution

Homogenized by a metal spatula

Solution was poured in a stock container

A serial dilution of spore suspensions was prepared with 0.01% of Tween 80 solution

Cover of the counting chamber was applied so that both counting areas to be covered

A drop of suspensions was spread over both niches of the counting camber with the help
of pipette

The counting chamber was fitted on the microscope table and the objective lense (10x
and 40x) was adjusted

Image was focused on overlapped lines under the objective lens

Only the spores dwelling within the 25 squares of counting area was counted

The spores’ number of each side of the counting chamber was recorded

200 spores was selected for counting

Formula Used:
Spores per ml (N) = Z x 1/10 to the power -4 x 1/Y
Z = average of spores count / 16 small squares
10 to the power -4 = overall volumes of 25 squares of the Neubauers counting chamber
Y = utilized dilution
(3) Pilot plant

Sugar was added in steaming hot water

Mixing and filtration was done

Then, it was added in feed tank through pipe

Now, sugar was filled in sugar measuring vessel at the rate of 6L/hr
Soya been oil was added after every 80 hrs to control the formation of foam

Booster (citric acid) was added to boost up production

Air cartridge filter was sterilized and pH of booster feed was adjusted to 6.2 by addition
of 50% NaOH

During sterilization air line was closed and steam line was opened

Pressure of 1.5 psi was maintained

Filter was autoclaved at 121 degree C for 30 min

This, booster feed was directly added to fermentor through pipe line by closing and
opening various valves

Amount of feed was transferred to fermentor was measured by meter

Now, fermentation was carried out

(5) DNSA method

100 ml DNSA reagent was prepared by mixing 1 gm DNSA, 30gm Na-K tartarate and
1.6 gm NaOH in 100 ml of distilled water

A series of dilutions of 0.2mg/ml of maltose in the same reagent was prepared

2.8 ml of distilled water was added to each dilution of standard in test tubes gently.

And mixing was done

1 ml of DNSA reagent was added in each test tube

Again, mixing was done

The test tubes were incubated for 10 min. in boiling water bath until the color of the
DNSA turns orange-red

Then, they were allowed to cool at room temperature

And finally absorbance was taken at 540 nm

3, 5 DNSA ------------------------- 3, Amino, 5 nitro salicylic acid (On Reduction)

(Yellow) (Orange – red)

Table No.7.1 - Maltose Standard Curve

Conc. Of Absorbance
0 0
20 0.01
40 0.012
60 0.03
80 0.05
100 0.077
120 0.11
140 0.119
Graph between concentration of maltose and absorbance.

maltose standard


0 20 40 60 80 100 120 140
conc of maltose (µg/ml)

1. School: Education is the cradle of a successful developing nation and Alembic

committed to it by managing an educational trust.

2. Hospital: Alembic has it’s a full fledged, state of the art medical center i.e. Bhai Lal
Amin General Hospital next to the township, therefore easily accessible to all
employees. The hospital is well equipped with an X-ray department, ICU beds, where
medical and surgical emergencies can be dealt with. It also has ambulance facilities
that can transport the patient to a hospital in case of emergency. It also has a tie up
with Escorts for Heart Care.

3. Recreation /Sports: Alembic offers diverse recreational facilities for the employees
and their families. A well-equipped gymnasium is available inside the township. From
playing table tennis, badminton, lawn tennis and cricket, employees can do just what
they like to get fresh and rejuvenated. Alembic also organizes ‘Intra Company' sports
events from time to time.
Since the very inception, the Alembic has built houses, parks, schools and market for
the employees, their families and others residing nearby. The beautiful Landscape of
Township covers huge area and has quarters for all its employees. Modern amenities
such as Gas Pipeline, electricity, water, sanitation and welfare facilities like super
markets, Educational institutions, company-owned well equipped hospital, a cricket
academy headed by Kiran More, cricket ground, parks, post office, ATMs, Banks etc
make the township self sufficient. Guesthouse facility is also provided for the
outsiders. As corporate office is inside the township, the commutation has made the
life far simpler Alembic employees. ALEMBIC also has Employees' cooperative
society, which provides loans at subsidized rate of interest on contribution of monthly

Alembic network spans 75 countries globally. This intricate channel of distribution is

fine-tuned to the specific needs of the areas, always placing customer needs as a
They are globally represented in all the major countries by a chain of agency tie-ups and
end user tie-ups.

Distribution network in India

ALEMBIC have a distribution network that spans 29 states in India. ALEMBIC sales &
marketing field force is one of the largest in India. Entire field force operates from 20
regional offices throughout the country, maintaining relationships with over 120,000
doctors and 200,000 pharmacies. ALEMBIC distribution network in India includes 42
distributors & consignee agents, 16 Alembic Regional Depots and 4200 wholesale
dealers who ensure availability of our products across the country.

Prescription Drug Marketing Act (PDMA)

The Prescription Drug Marketing Act of 1987 (PDMA) was signed into law by the
President April 12, 1988. The PDMA was enacted (1) to ensure that drug products
purchased by consumers are safe and effective, and (2) to avoid the unacceptable risk to
American consumers from counterfeit, adulterated, misbranded, sub potent, or expired
drugs. The legislation was necessary to increase safeguards in the drug distribution
system to prevent the introduction and retail sale of substandard, ineffective, or
counterfeit drugs.

Alembic believe that in the future, its global presence will serve as the perfect vehicle for
further growth. While it has seen considerable success in non-regulated markets, they are
also aggressively making in-roads into regulated markets.

Alembic has built a reputation for itself in the international pharmaceutical and fine
chemical arena, as a company focusing on delivering quality products & services that
conform to global norms. They understand specific needs of local markets of various
countries around the world. This will allow them to collaborate through every stage of an
international product launch, which makes them the ideal business partner for any global
corporation. There international business in API's, BPC's & FDF's is responsible for
enhancing life in over 75 countries in 4 continents around the world.