A REPORT

ON
Industrial Tour
Submitted in Partial Fulfillment of the Requirements
for the Degree of

Bachelor of Pharmacy
by
Mohsin Beg
B. Pharm. IV Year, VIII Semester
(Roll no. 1900560500053)
Faculty of Pharmacy
BBDNIIT, Lucknow

to the
Dr. A. P. J. Abdul Kalam Technical University, Lucknow
(Formerly Uttar Pradesh Technical University, Lucknow)
2022-2023
 CERTIFICATE

This is to certify that Mohsin Beg (ROLLNO. 1900560500053) has carried out the Industrial
Tour for the award of Bachelor of Pharmacy from Dr. A.P.J. ABDUL KALAM
TECHNICAL UNIVERSITY, LUCKNOW under my supervision. This report embodies
result of original work and report are carried out by the student and the content of the report
do not form the basis for the award of any other degree to the candidate or to anybody else from
this or any other university/institution.

Ms. Neelam Datt

Associate Professor

BBDNIIT, LUCKNOW

Date:
 DECLARATION

I hereby declare that the Industrial Tour mentioned in this report was carried out by me.

Date: Mohsin Beg

Roll No. 1900560500053

B.Pharm. IV Year, VIII semester,

BBDNIIT, LUCKNOW.
 ACKNOWLEDGEMENT

I, consider a great privilege and honour having an opportunity to undergo the industrial tour in
Galpha Laboratories Ltd, Akums Drugs and Pharmaceutical Ltd, Glenmark
Pharmaceuticals.

I would like to express my indebtness appreciation to my director Prof. (Dr.) Shailendra K. Saraf
his constant guidance and advice played the vital role in making the execution of the report.

I owe my gratitude to Associate Prof. Neelam Datt for providing her valuable time and support
in cpmpleting the tour and preparing the report on industrial tour.

Mohsin Beg

Roll No. 1900560500053

B.Pharm. IV Year, VIII semester,

BBDNIIT, LUCKNOW.
 TABLE OF CONTENT

S.NO CONTENTS PAGE NO.

1 Galpha Laboratories Ltd.

5
6
 GULPHA LABORATORIS LTD

INTRODUCTION
Galpha is proud of its strong international presence in regulated and emerging
pharmaceutical markets. The company continues to follow a promising path by strategically
expanding its business, strengthening its manufacturing facilities, and enhancing the
capabilities of the entire organisation. We also aim to boost our revenues by exploring
opportunities in the untapped healthcare markets, and working with our business partners
worldwide.

About Galpha
Galpha Laboratories is a leading manufacturing and marketing company of pharmaceutical
formulations (Finished Dosage Forms) in India.We express gratitude for our strong foothold
in the international market of regulated and emerging healthcare services. The company
strives to move forward on a promising path by strategically expanding its business,
strengthening its core manufacturing facilities, and enhancing its capabilities. We also look
forward to boosting the companies revenue by discovering new markets and close
collaborations with our business partners worldwide.

Fig.- 1Galpha Laboratories Premises

Institution
The Institution Division is another branch of Galpha that contributes to achieving our dream
of delivering the best-in-class healthcare solutions across India. In a bid to maximise its
positive impact towards helping the ailing masses, it boasts an enviable presence in various
therapeutic pharmaceutical segments, such as:

Multivitamins

Multiminerals

Hematinics

Muscle relaxants & anthelmintics

NSAIDs

Intestinal anti-infectives

Antipeptic ulcerants

Digestive enzymes

Oral and Injectable antibiotics

Enemas

Formulations and cough preparations

Fig.-2 Products manufactured by Galpha Laboratories Ltd.

Manufacturing Facilities
GAlphas Baddi Unit 1 is a huge manufacturing facility having different product lines such
as General Oral solid dosages facility, Pellets manufacturing facility, Oral liquid
manufacturing, and Soft Gel. All our manufacturing facilities are ISO certified, having ISO
9001:2008, ISO 14001: 2004, and are accredited by WHO CGMP.

Export
Galpha Laboratories have a strong international presence in the pharmaceutical and
healthcare markets

Galpha operates its International business through various business models like:

-Private markets

-Tenders

-Licensing and registration

-Contract manufacturing

-Variety of distribution models

With our 100% quality motto, Galpha has successfully leveraged its production, research,
and development for supplying quality and affordable pharmaceuticals across the globe.

In addition, Galpha also boasts its unique and highly-respected position in many private
markets. All thanks to the company’s expert “know-how” in marketing run by a highly
professional sales and marketing team.
 GLENMARK PHARMACEUTICALS

INTRODUCTION
Glenmark Pharmaceuticals Limited is an Indian multinational pharmaceutical company
headquartered in Mumbai, India.

Glenmark Life Sciences (GLS) was spun off from Glenmark Pharmaceuticals in 2019, in order
to focus on developing the Active Pharmaceutical Ingredients (API) business. We make high-
quality, affordable APIs by unlocking the possibilities of chemistry and engineering in R&D
and manufacturing. We are now driven by an independent management team and have
developed a robust API portfolio, built capacities and manufacturing efficiency in order to
grow our business with our customers, worldwide. We have established strong relationships
with leading global generic pharmaceutical companies that mainly operate in the US, Canada,
Japan and Europe, which are highly regulated markets. Our ability to service customers in a
complex regulatory framework positions Glenmark Life Sciences differently with customers,
giving our business an added dimension of stability and longevity. From product selection &
development to commercialisation, we judiciously blend science, technology and economics
to stay ahead of the curve.

WORK
Its business banks upon a portfolio of 137 molecules that have been developed over the years.
These molecules cater to chronic therapeutic segments such as Cardiovascular (CVS) disease,
Central Nervous System (CNS) disorders, pain management and anti-infectives. The
addressable front-end market size of these molecules is around USD 180 billion across markets.
It has filed these molecules in all major markets in order to service our pharmaceutical
customers, who are present in these markets at the front end. As a result of these filings, it is
able to commercialise these APIs to over 700 customers worldwide. In addition to our generic
pharma customers, we are also able to offer these molecules to innovator players as part of
their lifecycle management strategy, post genericization of their portfolio. This allows it to
leverage our existing portfolio to generate additional business through innovator players who
are looking for an affordable option for their APIs across various markets.

We develop, manufacture and supply select high-value, non-commoditised APIs for our global
customers who are pharmaceutical companies operating in their respective markets. Let's take
a closer look at each of these terms:

Product Development
Our product development starts with portfolio selection where we target non-commoditised
APIs with high-end chemistry in order to develop a relatively high entry barrier. More recently,
we have added complex molecules with an even higher entry barrier, not only from a chemistry
perspective but also from a characterisation perspective. All our molecules are developed for
global markets with a specific focus on regulated markets, where we target first wave launches.
For the first wave of development, our focus is on speed-to-market allowing us to be part of
the customers’ filing early. Later, based on patent expiries, we offer these APIs through cost-
optimised processes in markets where patents expire sooner than in regulated markets. These
cost-optimised processes allow us to cater to customers in regulated markets in the second wave
of launches. Apart from new molecules, we also focus on Cost Improvement Projects (CIP) on
mature APIs, to address second-wave launches and with these best-cost APIs, our customers
sustain the competition; thereby creating an effective lifecycle management strategy for our
mature APIs.

History
It was founded in 1977 by Gracias Saldanha as a generic drug and active pharmaceutical
ingredient manufacturer. He named the company after his two sons. The company initially sold
its products in India, Russia, and Africa. The company went public in India in 1999, and used
some of the proceeds to build its first research facility. Saldanha's son Glenn took over as CEO
in 2001, having returned to India after working at PricewaterhouseCoopers. By 2008 Glenmark
was the fifth-biggest pharmaceutical company in India.

By 2011 the founder of the company was one of the richest men in India, and Glenmark had
worldwide sales of $778 million, a 37% increase over the last year's sales; the growth was
driven by Glenmark's entry into the US and European generics markets.

In the mid-2010s the generics industry in general began transitioning to the end of an era of
giant patent cliffs in the pharmaceutical industry; patented drugs with sales of around $28
billion were set to come off patent in 2018, but in 2019 only about $10 billion in revenue was
set to open for competition, and less the next year. Companies in the industry responded with
consolidation or trying to generate new, patented drugs.

Glenn Saldanha took the company down the path of seeking innovation, which was
controversial within the company and with shareholders. The company focused on new drugs
and biosimilars in the fields of cancer, dermatology and respiratory diseases, which it sought
to monetize by partnering with major pharmaceutical companies.

In 2016 it had four such drugs in clinical trials. For the financial year 2016–2017 its sales were
around 81 billion INR (ca. $1.25 billion), making it the fourth-biggest Indian pharmaceutical
company.

In May 2019, Yasir Rawjee was elected as CEO of Glenmark Life Sciences.
Observations
Orientation and Departments of the Industry: The company complies of the following
departments in pharmaceutical sectors and I have visited all the departments as trainees.

The departments are:

1-Quality assurance department

-Quality control.

-In-process control

2-Production area
-Dispensing.

-Granulation.

-Compression.

-Encapsulation.

-Coating.

-Filling and sealing.

-Packaging.

3-Technical service department.

4- Product development department

1-Production Area

Dispensing
The process by which active ingredient and excipients are received from ware house into the
production area and weighing materials according to dispensing order sheet (DOS) is called
dispensing. In case of different batch of same product, excipients of both batches are weighted
first then active ingredients are weighted. There is no need of change over of instrument used
in production area. This process reduces the possibility of contamination.

Instruments available:- Balance- Name: Metler Toledo (area B)Capacity: 150kg; 6kg.
Plastic Platform (reduces particle formation than wooden platform)

Exhaust system.
Limitations and solutions:
 According to Good Manufacturing Practice (GMP) the balance should not be replaced
from their original place, but balances are frequently replaced for various reason. This
may cause weight variation from batch to batch. More sophisticated balance may be
used.
 Exhaust duct used in dispensing area is not sufficient to remove dust particle that
generated inside it.
 Lighting system in the dispensing area suitable for the deposition of dust particles.
 Tiles are used in walls which causes dust particle deposition that is also difficult to
clean. Fungal growth may occur in the floor during damp season.
 Some ingredients are moisture sensitive. For their stability humidity control (dry syrup-
relative humidity below 30%) is essential in every step of manufacture. In dispensing
area Bhas no humidity control system.

Granulations:
Granulation is the process in which powder particles are made to adhere to form larger particles
called granules. Granules are usually used in the production of tablets or capsules.

Purpose of granulation:
 Granulation prevents segregation of the constituents in the powder mix.
 It improves the flow properties of the powder mix.
 It improves compression nature of powder.

Types of granulation: Three types of granulation techniques are used-

 Dry granulation
 Wet granulations
 Spray granulation

1.Dry granulation:
This method is applied for drugs which do not compress well after wet granulation or those
which are sensitive to moisture. It may be performed following two ways

Wet granulation involves the massing of the powder mix using a solvent. The solvents used
must be volatile, so that they can be removed by drying, and nontoxic.

Steps involved:
 Weighing.
 Shifting.
 Dry mixing.
 Wet mixing.
  Drying.
 Crushing.
 Addition of disintegrants.
 Lubrication.

2.Spray granulation:
This technique utilizes the technology of fluid bed drier. Heated air is blown through a bed
ofunmixed powders and mixes the powders. Granulating liquid is pumped through a spray
nozzleover the particle.

Limitations and solutions:

Multimill and shifter frequently used in granulation technique. Production A and production B
use these two instruments by shifting. It reduces productivity.

No final mixer (e.g. BHOLE MIXER) present in production area B; which is essential for
quality product.

Compression:
Compression of powder means reduction in bulk volume of a material as a result of
displacementof the gaseous phase. Compression technique used for the manufacture of tablet.

Machines available:
 Manestry (unipress): single rotary, 20 punch.
 Clit machine: double rotary, 29 punch.
 Se-Jong tablet machine: single rotary, 30 punch.

Tablet machine parts:

 Hopper.
 Fed frame.
 Feed paddles.
 Draw down cam.
 Weight controller Fill station.
 Pre-compression roller.
 Main compression roller.
 Compression sration.
 Ejection cam.
 Take off blade.
 Ejection station.
 Take off chute.

Stages of compression:
1- Feed frame over die.
 2- Fill.
3- Scrapping.
4- Feed shoe pull back.
5- Compression.
6- Ejection

Tablet manufacture problem:

 Punch filming and sticking.
 Weight variation.
 Capping/lamination.
 Mottling.
 High friability.
 Low hardness.
 Variable hardness.
 Bisection or embossing

Limitations and solution:

Vacuum system used in both Clit and Se-Jong tablet machine to introduce granules, that reduce
the requirement of manpower & increase productivity – but it produce dust particle which
contaminate environment. Manestry tablet machine has no such problem.

Weight of tablet digitally controlled in both Manestry and Se-Jong tablet machine that reduce
weight variation and also easy to control than clit machine which is manually controlled.

Pre-compression roller reduce the air inside the granules, that reduce cracking problem –absent
in clit machine.
 AKUMS DRUGD AND PHARMACEUTICALS LTD.

INTRODUCTION

Akums drugs and pharmaceuticals ltd. is the largest contract manufacturing pharmaceutical
company of India. The organization deals in the manufacturing and export of formulations in
a wide spectrum of dosage forms & therapeutic segments. The company is currently supplying
to almost all Indian and multinational pharmaceutical companies across the globe. The 10 state-
of-the-art facilities are dedicated to oral solid dosage forms (with separate units for beta lactum
and non-beta lactum formulations), Oral liquid dosage forms, Sterile dosage forms (Injectable,
eye, ear & nasal), hormonal (oral and injectable), Ointments & cosmetics, Ayurvedic, food
supplements & nutraceuticals and animal health care. In a span of few years, the organization
has become the icon of Indian Pharmaceutical manufacturing industry and currently
manufactures around 9% to 10% of the country’s total medicinal requirements. With creme-
de-la-creme of dedicated pharmaceutical personnel and standardized practices, Akums has
been successful in attaining national and international accreditations and building trust on
Efficacy, Safety & Quality. The organization is certified with WHO-GMP, ISO 9001 : 2008,
ISO 14001:2004 certificates and various international accreditations, like; ANVISA, Brazil,
NAFDAC, Nigeria, FDB, Ghana, PMPB, Malawi amongst others.

Fig. 4 Akums premises

History

Akums began its journey in 2004 with a single manufacturing unit at Haridwar. With the
constraints of limited resources, the following years proved remarkable to grow exponentially.
However, limitations never hindered growth; in fact, they doubled the confidence of the
visionaries to lead the company to a new height. This is a sheer reflection of the hard work,
devotion, and dedication of the Founders and Directors, Mr. Sanjeev Jain and Mr. Sandeep
Jain, along with the team to build this brand, a foremost pillar of the pharmaceutical sector.

The company has extended its reach with ten state-of-the-art facilities to offer world-class
manufacturing services and a comprehensive range of services, from formulation development
to market launch. The group deals in manufacturing and exporting formulations in a wide
spectrum of dosage forms & therapeutic segments. The corporation presently supplies almost
all Indian and multinational pharmaceutical companies across the globe and holds the record
of being the 67thlargest employer in the country, employing more than 15000 employees.

PRODUCTION

1-Nutravedics and Ayurvedic

Maxcure Nutravedics, a subsidiary of Akums Drugs & Pharmaceuticals Ltd was established in
2010. The facility is an ultra-modern, scientifically designed facility for the manufacturing
of Nutraceuticals, Food Supplements, Herbal & Ayurvedic Formulations, and Veterinary Feed
Supplements. The facility has been approved by US-NSF, which is a certification indicating
that the facility is compliant with the international regulatory standards.
Moreover, the manufacturing processes for nutraceuticals and food supplement products are
based on a scientific and conceptual amalgamation of traditional nutritional knowledge with
modern science. This approach ensures that the products manufactured at Maxcure Nutravedics
Ltd are safe, effective, and of high quality.

2-Cosmetics and Derma products

At Akums, we unify beauty with science to provide innovative cosmetic and dermatological
products that cater to the specific needs of each individual.
We understand that every individual’s skin is unique; therefore, we offer our
clients personalized solutions for all skin types.
The state-of-the-art manufacturing along with R&D, coupled with commitment to quality,
make Akums stands out as a top-tier cosmetic and derma manufacturer in the market.

Akums is known for innovative approach in drug development, utilizing cutting-edge

technology and research to create patient centric medicines. Our dedication to innovation has
earned us the reputation as a leader in the pharmaceutical industry, with a commitment to
improve healthcare in India and worldwide. Our innovative approach has resulted in numerous
accolades, being named the “Best Pharma Company” in India” in 2020 by the Economic
Times.
Our philosophy is based on quality, service, innovation, and continuous improvement, and we
strive to exceed expectations every time. We are a customer-focused company that takes the
time to listen and understand our clients’ needs, and we develop tailor- made solutions that
meet the exact requirements of their projects. Our quality philosophy is embedded in
everything we do, from design to manufacturing to supply chain management and beyond.

Good manufacturing practice (GMP) department:

This department overview/ inspect the function of total production system. This department
has no routine work but work in every where to inspect/ assure good manufacturing practice .
Quality compliance department:
This department deals with the problems arises in other production related department.
Heresome people are always engage to solve the problem. It is absent in the plant, related
personnel solve their problem through discussion with proper personnel. It is essential for
aquality concern department, because the problem arises if not solve by proper hand may
reduce productivity.

High performance liquid chromatography (HPLC):-High performance liquid

chromatography (HPLC) is a powerful method for the separation of complex mixture,
especially when many of the components may have similar polarities.Two types of analysis
possible with HPLC-

•Isocratic analysis-(to separate single compound).

•Gradient analysis-(to separate mixture of compounds).

Analytical column:
Here the actual separate with 2 to 4.6 cm diameter. It is packed with the stationary phase. Silica
gel is the material most frequently employed for micro particulate column packing. It may be
used as such for absorption chromatography, but more often liquid phases for partition
chromatography are bonded chemically to its surface. These include alkyl groups with the
chain length of 1, 2, 8 or18 carbons, cyanopropyl groups, phenyl groups and ion exchanger.
Chiral stationary phases also used for the separation of optical isomers.

Detectors:
Ultra-visible spectrometer.

Product development department

Based on electrochemical

Amperometry.

Columetry.

Polarograph

Photoconductivity.
 Fig 5- HPLC Fig.6- Autoclave

Product development department

Functions:
Product development (PD) department has following functions:

 Document development.
 Galenical development.
 Analytical development.
 Packaging development

Document development: Product development department generate batch manufacturing

record (BMR), dispensingorder sheet (DOS), packaging order sheet (POS) initially for a newly
launched product and also maintain the document of their functions.

Galenical development: Galenical development involves the development of the

functions of production area for the production of a product. It develops the formulations by
trial and error method.

Analytical development: Analytical development involves the development of the

functions of quality control department tfor the production of a product.

Packaging development: Packaging development involve the design of primary and

secondary packaging for a particular product or routine check of the packaging materials.

Technical service department

This department is called power house of any type of plant. In a pharmaceutical plant it
providefollowing types of services for the continuation of productivity-
Maintenance support: Following maintenance support given by technical service
department-

 Protection of machineries.
 Preventive measures.
 Breakdown support.

Supply support: Supply support maintains blood-stream of a plant. It provide following

supply to the various part of plant-

 Compressed air.
 De-ionized water.
 Cold and hot water.
 Electricity.
 Gas and
 Steam.

Lubrication:- Lubrication of machineries routinely to prevent friction and subsequent

damage.

Incinerator:- To destroy waste material by using fire. Here materials used for once and have
no more used usually destroyed.

Service:
 Car workshop.
 Carpeting.
 Painting.

Maintaining heating, ventilation and air conditioning (HVAC) system.

Instruments used for the supply support:

Electricity:-Required electricity mainly obtained from DESA, incase of load shedding heavy
duty generatorprovide electricity.

 Generator:-Type: diesel operated

 Capacity: 1050 kilowatt.
 Requirement: 450 kilowatt.

Compressed air:- Compressed air is provided by oil free compressor. Air is passed through
passed various grade of filter to eliminate particle. These prevent contamination from oil and
dust particle.

 Name of compressor:- Sullair.

 Functional mechanism: air is passed through a screw system device.
Steam:-A boiler is used to boil water to110ºC and produce steam for production area B. Heat
is generated by using gas. Generated steam is used in fluid bed dryer.

Cold water:-Chiller is used to produce cold water (6ºC) for HVAC system (to cool the air).
After circulating this cold water through close looped HVAC system temperature become
12ºC. This raised temperature is released to environment through another closed loop system
of water circulation system. Here temperature of water changed from 37ºC to 30ºC and
temperature released. So there no loss of water. Capacity of chiller: 250 ton.

Hot water:-Boiler is used to produce hot water (110ºC) for HVAC system (to dry the air).
After circulating this hot water through close looped HVAC system temperature become 90ºC.
This loosed temperature is used to develop HVAC system. The hot water also flows through a
close looped system and thus no loss of water.

Water supply:-Water is supplied to plant by using a deep tube well. It supplies water from
120m deep of soil.

Waste water management:-Water used in plant released to environment after proper

treatment. At first water is passed through the various grade of filter to remove particle and
bacteria cultivated in treatment plant to engulf dissolve chemicals. It prevents water
contamination.

Deionized water plant: In pharmaceutical plant deionized water used in place of normal
water as the ion present in water may produce some adverse reaction to product and also may
alter chemical assay.
 Outcome of Training
Pharmacy is a professional subject. As a student of pharmacy department, I need to have
theoretical as well as practical and industrial knowledge. In-plant training helped me to acquire
knowledge on drug manufacture and manufacture management; and it will be very much useful
in my professional life.

I am concluding my report by giving thanks to God and also those who has to face hard work
for me.
 BIBLIOGRAPHY
1-https://glenmarkpharma.com/product-overview/business-development/

2-https://glenmarkpharma.com/innovation/rd/

3-https://www.academia.edu/27224776/Industrial_Training_Report

4-https://www.slideshare.net/Kirti7052/kirti-shuklas-pharmaceutical-industrial-visit-ppt

5-Gendre C., Genty M., César da Silva J., Tfayli A., Boiret M., Lecoq O., Baron M., Chaminade P.,
Péan J-M., Comprehensive study of dynamic curing effect on tablet coating structure, Eur. J. Pharm.
Biopharm, 81 (2012), 657-665

6-Coating machines Archived 2012-03-28 at the Wayback Machine, apteka95.com

7-Allen L. V and Ansel H. C. (2014). Ansel's Pharmaceutical Dosage Forms and Drug Delivery

8-Systems. Philadelphia: Lipincott Williams and Wilkins.

9-http://www.pharmaceutical-technology.com/products/softgels-for-clinical studies

10- Jariwala, D. M., Patel, H. P., Desai, C. T., Shah., S. A. and Shah, D. R. (2016). A Review on
Multiple Compressed Tablets. Journal of Pharmaceutical Science and Bioscientific Research, 6(3): 371-
375.

11-https://www.akums.in/success-story-

12:akums/#:~:text=Akums%20began%20its%20journey%20in,company%20to%20a%20new
%20height.

13- https://www.galpha.com/baddi-unit-1.php

14-https://www.galpha.com/baddi-unit-2.php