Bipin Shukla Industrial Report

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A REPORT

ON
INDUSRIAL TRAINING
Submitted in Partial Fulfillment of the requirements
For the Degree of

Bachelor of Pharmacy
By

BIPIN SHUKLA
B.Pharm. IV Year, VIII Semester
Roll No.2000560500030

Faculty of Pharmacy
BBDNIIT, Lucknow

to the
Dr. Abdul Kalam Technical University, Lucknow
(Formerly Uttar Pradesh Technical University, Lucknow)
2023-2024
CERTIFICATE

This is to certify that BIPIN SHUKLA (Roll no. 2000560500030) has carried out the Industrial

Tour for the award of Bachelor of Pharmacy from A.P.J. ABDUL KALAM TECHNICAL

UNIVERSITY, LUCKNOW under my supervision. This project report embodies result of original

work and studies are carried out by the student and the content of the project 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.

DR. SHEKHAR SINGH

ASSOCIATE PROF.
COORDINATOR (DISCIPLINE)
(PHARMACY)

B.B.D.N.I.I.T. LUCKNOW

Date:
DECLARATION

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

DATE : BIPIN SHUKLA

ROLL NO. 2000560500030

B.PHARM IV YEAR (VIII SEMESTER)

BBDNIIT, LUCKNOW
ACKNOWLEDGEMENT

This project is done in dedication to the GOD who has blessed me peace of mind, courage and
strength and also to my loving Parents who given me a lot of encouragement, valuable ideas and
support when needed.

First and foremost, sincere thanks to Prof. (Dr.) S.K.Saraf, Director, faculty of Pharmacy,
BBDNIIT for their constant encouragement and for providing facilities to complete the Practice
School project.

I welcome this opportunity to express my sincere thanks to Mr. Sameer Nagarajan Head HR in

Cadila Pharmaceuticals Limited, Survey no. 1389, Trans road, Dholka, Ahmedabad, India, 38822,

for his patience, generosity and sagacious guidance in at every stage of my Industrial Training.

I thanks also to my guiding teacher Dr. Shekhar Singh , Associate Professor, Coordinator

(Discipline) , Pharmacy for providing me best guidance to complete the Industrial Training .

BIPIN SHUKLA
TABLE OF CONTENT

S.NO CONTENTS PAGE NO.

1. Introduction 6-9

2. Plant Locations 10-12

3. Products List 13-14

4. Semisolids 15-16

5. Market Products 17-20

6. Outcomes of Training 21

7. References 22
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INTRODUCTION :

Cadila Pharmaceuticals Ltd. is one of the largest privately-held pharmaceutical companies in India.
Over the past seven decades, we have been developing and manufacturing affordable medicines for
patients around the world.Our innovation-led drug discovery processes ensure the health and well-
being of people around the world. Our enhanced investment in innovation and a strong track record
in research and development have produced medical miracles that have changed lives and made a
profound impact on real life.Being a care-focused, research-driven company, we are committed to
complying with the highest ethical standard in clinical research and medical practice. We want to be
valued not only for our pharmaceutical products but also for the way we conduct our research and
business activities.We lead our industry in demonstrating the application of cutting-edge research to
ethical business practices in producing the alchemy of optimum health outcomes for all.
Cadila Pharmaceuticals is an Indian multinational pharmaceutical company based in Ahmedabad.
The company's operations focus on manufacturing products ranging from active pharmaceutical
intermediates, finished formulations, food supplements, biotechnology products and pharmaceutical
machinery.

1995: BIRTH OF CADILA PHARMACEUTICALS


The Modi and Patel families decided to split the business in 1995, two entities were formed - Cadila
Pharmaceuticals Ltd (owned and controlled by Indravadan Modi and his son Rajiv Modi) and Cadila
Healthcare (owned by Ramanbhai Patel and his son Pankaj Patel family).
Cadila Pharmaceuticals has its formulation manufacturing facilities at Dholka, Gujarat (India);
Samba, Jammu (India) and at Addis Ababa (Ethiopia) and 2 API manufacturing facilities are located
at Ankleshwar, Gujarat. The manufacturing facility at Dholka and the API unit at Ankleshwar in
Gujarat are USFDA-certified; the overseas manufacturing facility at Ethiopia is the WHO - cGMP
compliant facility.
This towering vision of our founder Indravadan Modi which he spelled out in the year 1951 was the
genesis of brand Cadila. Born in a small village, Hansot of Bharuch district in South Gujarat on
February 18, 1926, during his life, he left a lasting impact on the Indian pharmaceuticals industry.

In 1951, he established Cadila to offer cost-effective drugs that eventually changed the dynamics of
the healthcare industry, in a country that was earlier wholly dependent on costly imported
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medicines. I. A. Modi is credited with the development of innovative and effective therapies for the
prevention of heart diseases, the incidence of which is on a sharp rise among young Indians, and
tuberculosis, which is also endemic to India. A nationalist at heart, I.A. Modi was determined from
the onset of this mission that the price of both these medicines must be pegged low to make them
accessible to the average Indian.

A product that has revolutionized the treatment for TB by reducing the dose of Rifampicin as it
contains Piperine, a potent bioavailability enhancer. By
reducing the dose to half, patients will have lesser
gastrointestinal adverse effects and better tolerability.
Improved patient compliance leads to better cure rate and
lesser treatment failure while maintaining therapeutic levels
of Rifampicin. It is available in the form of hard gelatin
capsule.

A pill that reduces the risk of CVD by 62% and stroke by 48% (The Lancet editorial – Sep. 2009).
Polycap, a single pill, contains 5 drugs namely -
Hydrochlorothiazide (12.5mg); Atenolol (50mg); Ramipril
(5mg); Simvastatin (20mg); Acetyl Salicylic Acid (ASA,
100 mg, Enteric Coated) leads to ease of Dosing i.e., once
daily dosing, improved patient compliance. Cadila is
marketing Polycap in India and few other countries
successfully. The Polypill has been accepted by various
countries and guidelines as pill of choice to reduce cardio
vascular risk. It is available in the form of hard gelatin
capsule having tablet in capsule technology.

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MYCIDAC-C is a suspension of heat killed


Mycobacterium w (Mw), Indicated for treatment of
NSCLC (Non-small Cell Lung Cancer) along with other
chemotherapy agents leading to improvement in overall
response, QOL and survival of patients. MYCIDAC-C is
available in a pre-filled syringe and does not require any
special preparation, prior to administration

Rabeprazole sodium for intravenous administration to treat


various diseases like GERD, Upper GI Bleed, APD etc. It
has rapid onset of action with sustained and long term
lowering of gastric Ph. Rabeloc is freely compatible with
commonly used IV fluids and diluents and should be given
IV. It is very much safe in special population like
elderly/liver/kidney dysfunction patients as having the lowest
drug interactions because of non-enzymatic pathways for
metabolism. Rabeloc is available as in vial.

Sepsivac, an immunotherapy treatment is a first-in-the-world


innovation in Sepsis management by Cadila. The drug has
received approval from Drug Controller General of India
(DCGI) for immunotherapy treatment in Sepsis or septic
shock. Sepsivac contains mycobacterium w, an
immunomodulator which is a non-pathogenic
mycobacterium. As a result of the immunomodulator effect,
Sepsivac effectively saves more lives in sepsis and has also
found use in COVID-19 management

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Cadiflu-S with WHO approved strains is India’s first VLP


based vaccine used for protection against seasonal
influenza. Influenza, commonly known as the “flu”, is an
acute infection of the respiratory tract caused by influenza
viruses. Cadiflu-S developed in collaboration with
Novavax, Inc. USA is non- infectious and can be safely
used in patients with compromised immunity, respiratory
diseases like asthma and COPD, cardiovascular diseases
and diabetes. It is administered as a single dose of 0.5 mL
intramuscular injection.

Vitamin-D - the world's first aqueous formulation of


cholecalciferol, setting a new benchmark in the treatment
of Vitamin D deficiency. This ground-breaking innovation
demonstrates superior pharmacokinetics (PK) and
pharmacodynamics (PD) compared to traditional oil-based
cholecalciferol preparations available in the market.
Vitamin D deficiency is a major health concern globally,
contributing significantly to the outcomes of various
diseases. Cadila Pharmaceuticals' innovative aqueous
cholecalciferol injection offers a unique solution with
rapid correction of Vitamin D deficiency in short span of
time.

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LOCATIONS OF CADILA PHARMARMACEUTICALS

Dholka Manufacturing Plant


Survey No. 1389, Trasad Road,
Dholka, Ahmedabad, India, 382225
+91 2714 220315
+91 2714 221481

Jammu Manufacturing Plant


IGC, Phase-1, SIDCO, Samba,
Jammu, J&K, 184121
+91 01923 246981

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Corporate Office
Sarkhej-Dholka Road, Bhat,
Ahmedabad, India, 382210
+91 2718 225039
+91 2718 351000
+91 2718 251000
+91 2718 225001

Ankleshwar
API SBU
294, GIDC Estate, Ankleshwar,
India, 393002
+91 2646 250051
+91 2646 223846

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CADILA PHARMACEUTICALS PLANT AHMEDABAD

Location: Survey no. 1389, Trans road, Dholka, Ahmedabad, India, 388225

Cadila Pharmaceuticals Ltd. is one of India’s leading integrated privately held pharmaceutical firms,
located in Ahmedabad, Gujarat. The firm develops and produces pharmaceutical products in India
and sells and distributes them in over 100 countries. The organization places a high emphasis and
priority on research, whether it is in biotechnology, APIs, formulations, plant tissue culture or
phytochemistry to innovate in various therapeutic areas including gastrointestinal, cardiology,
pulmonary, oncology, gynaecology, cardiovascular, Diabetology, and osteology. Its undaunted
commitment to create affordable miracles in therapeutic areas with significant unmet medical needs
to serve the society & community at large, has led to several world-first breakthroughs.

The Samba plant specializes in the production of a wide variety of drugs, totaling 140 types. It was
commissioned in September 2002, showcasing Cadila Pharmaceuticals' commitment to expanding
its manufacturing capabilities. With an expansive area of 11 acres, the plant represents a significant
investment in pharmaceutical manufacturing infrastructure in the region. The project type being
derivative indicates a focus on producing pharmaceutical derivatives or derivative-based products.
The total budget for the project is 100 crores.The project was expected to be complete within around
800 days from the date of commencement. Cadila Pharmaceuticals is the only Indian manufacturer
of natural Streptokinase and Hyaluronic Acid products.

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PRODUCTS LIST

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INTRODUCTION
A semi-solid is a state of matter. It is a substance that is in between a solid and a liquid. Another
name for a semi-solid is a quasi-solid. Mayonnaise is an example of a semi-solid. Mayonnaise does
not hold its shape like a solid but does not flow like a liquid. Gel or cream are terms often used of a
semi-solid. Normally semi-solids are covalent in their chemistry. Covalent substances get softer and
softer until they melt. Ionic substances melt at one temperature and do not get softer. Butter is a
semi-solid when it is warm. Butter does not hold its shape but it does not flow like a liquid. Paint is
also a semisolid, since it is highly viscous. The shape of curd is semi-solid, and is different from
milk, which is liquid.Semi solids are the topical dosage form used for the therapeutic, protective or
cosmetic function. They may be applied to the skin, or used nasally, vaginally, or rectally…
Pharmaceutical semisolid dosage preparations include :ointments, pastes, cream, plasters, gels
etc.They contain one or more active ingredients dissolved or uniformly dispersed in a suitable base
and any suitable excipients such as emulsifiers, viscosity increasing agents, anti microbial agents,
antioxidants, or stabilizing agents etc..Semi-solids are traditionally manufactured in large
homogenizers as a batch process and tested off-line after manufacturing. Measurements during
manufacturing with process analytical technologies (PAT) can be an integrated part of a control
strategy to ensure high quality in every batch and enhance process understanding . The definition by
the US Food and Drug Administration of PAT is “a system for designing, analysing, and controlling
manufacturing through timely measurements. PAT is a corner stone for continuous manufacturing;
which is characterized by the constant charge and discharge of excipients and product, respectively
It is an acknowledged approach for manufacturing of different pharmaceutical solid dosage forms
but is not yet a commonly applied solution for semi-solid dosage forms. Development of PAT for
semi-solids is essential to move towards continuous manufacturing. PAT for pharmaceutical semi-
solid formulations has been introduced previously, for example by measuring API concentration and
physical changes using spectroscopic tools.

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ADVANTAGE OF SEMI-SOLID DOSAGE FORM

• It is used externally
• Probability of side effect can be reduce
• First pass gut and hepatic metabolism is avoided.
• Local action and Site specific action of drug on affected area.
• Convenient for unconscious patient or patient having difficulty on oral administration.
• Suitable dosage form for bitter drugs.

DISADVANTAGES OF SEMI-SOLID DOSAGE FORM

• There is no dosage accuracy in this type of dosage form


• The base which is used in the semi-solid dosage form can be easily oxidized.
• May cause staining.
• They are bulky to handle.
• Application with finger may cause contamination.
• Physico-chemically less stable than solid dosage form.
• May cause irritation or allergy to some patients

IDEAL PROPERTIES OF SEMISOLIDS PHYSICAL PROPERTIES:

• Smooth texture
• Elegant in appearance
• Non dehydrating
• Non gritty
• Non greasy and non staining
• Non hygroscopic

PHYSIOLOGICAL PROPERTIES

• Non irritating
• Do not alter membrane / skin functioning
• Miscible with skin secretion
APPLICATION PROPERTIES
• Easily applicable with efficient drug release.
• High aqueous wash ability.

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OUTCOMES OF TRAINING:
Training is the most important part of modern Professional courses. It is simply an introduction to
the students towards their future jobs and the environment to be handled.
Industrial Training outcomes for me are described as follows ,I have learned about :-
❖ Industry ,industrial areas ,its structure and industrial environment
❖ Talking way to senior and junior persons

❖❖ Manners used for other members


of industry
❖ Procedures and tests followed in Quality control department and its responsibilities
❖ Responsibilities of Quality Assurance department
❖ IPQA and IPQC department and its responsibilities
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❖ Packing materials used for pharmaceutical Products


❖ Responsibilities and functions of Store Department
❖ Instruments used in QC Department
❖ Equipments used for Production and Packing of Pharmaceutical Products
❖ Raw material Dispensing method for batch production
❖ Process and Procedures followed in Production Department
❖ Documentation of QC and QA department

REFERENCE

1.https://en.wikipedia.org/wiki/Pharmaceutical_manufacturing

2.http://pharmaceuticals.gov.in/pharma-industry-promotion

3.http://www.pharmatips.in/Articles/Quality-Control/Quality-Control-Department-In-Pharma-
Industry.aspx

4.https://en.wikipedia.org/wiki/Drug_packaging

5. https://en.wikipedia.org/wiki/Pharmaceutical_industry

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• IP/USP/BP
• Semalty et al. ...
• Niazi SK, Handbook of Píefoímulation, Infoíma Health Caíe, 2007
• Aulton ME (ED), Phaímaceutics: ľhe science of Dosage foím design, II edn,
Chuíchill Livingstone, London, 2002.
• Bankeí GS & Rhodes ľ, Modeín Phaímaceutics, CRC Píess.
• Lachman L/Liebeíman HA, Kanig JL, ľhe ľheoíy And Píactice Of Industíial
Phaímacy,4E (2013)

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PLANT PROFILE

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PLAN OF WORK

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PROPOSED METHODOLOGY

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EVALUATION PARAMETERS

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REFERENCE

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