SESSION: 2018 - 19
A report is submitted
for the partial fulfillment of the degree of
Bachelor of Pharmacy
SUPERVISOR
Co-SUPERVISOR
Prof. Sushil Kumar Kashaw
(PROFESSOR, DOPS, DHSGU, SAGAR)
MR. VAIBHAV RAJORIYA
MS. MITALI MISHRA
(GUEST FACULTY, Dops, DHSGU, Sagar)
SUBMITTED BY
AYUSH JAIN
y16150109
B.PHARMA. VI SEM
DEPARTMENT OF PHARMACEUTICAL SCIENCES
DR. HARI SINGH GOUR VISHVAVIDYALAYA
(A CENTRAL UNIVERSITY)
S G R M.P.
CERTIFICATE
This is to certify that Chandrabhan Patel of B Pharm VI semester of academic session 2018-19 of
Department of pharmaceutical sciences Dr. Hari Singh Gour Vishwavidyalaya Sagar (MP) has
satisfactorily completed his industrial tour & submitted industrial tour report for the partial
fulfillment of the degree of Bachelor of Pharmacy.
Prof. Sushil Kumar Kashaw Mr. Vaibhav Rajoriya
Ms. Mitali Mishra
ACKNOWLEDGEMENT
I have taken efforts in this Industrial Tour. However, it would not have been
possible without the kind support and help of many individuals and
organizations. I would like to extend my sincere thanks to all of them.
I am highly indebted to Dr. S.K. Kashaw Sir (Assistant Professor, Dept. of
Pharmaceutical Sciences, Dr.H.S. Gour University, Sagar) for their guidance
and constant supervision as well as for providing necessary information
regarding the project & also for his support in completing the Industrial Tour.
I would like to express my gratitude to Mrs. Mitali Mishra Mam and Mr.
Vaibhav Rajoriya Sir (Research Scholars) for their kind co-operation and
encouragement which help me in completion of this tour successfully.
I also would like to express my sincere thanks to Prof. S.K. Jain Sir (HOD of
Dept. Of Pharmaceutical Sciences, Dr.H.S.Gour University, Sagar) for
providing us the necessary permission to go on this tour and for his constant
guidance.
I would like to express my special gratitude and thanks to industry in-charge
for giving me such attention and time. Dr. Bharaat Vyas (Amneal
Pharmaceuticals); Mr. Madivannan (Bestcare Formulations) ; and Mr. J.W.
Mathias (BioPlus Life Sciences) are few to add in the list.
I am grateful to my parents for allowing me to go in the tour and for their
irreplaceable guidance and help.
My thanks and appreciations also go to my colleague in developing the tour
and people who have willingly helped me out with their abilities.
Chandrabhan Patel
Y16150146
B.Pharm 6th Sem
1. OBJECTIVE OF THE TOUR
A pharmaceutical formulation and its research invests play important role in the young generation of
the pharmacy students because without seeing the process we don’t know about the formulation and
development of any medicine because of that an industrial visit should be compulsory to the
pharmacy students. Pharmaceutical industry is a most diverse, R&D oriented, hypercompetitive and
knowledge sensitive industry. Competitive intelligence (CI) is a process of ethically and systemic
data gathering from operating system to draw important business conclusions. Use of CI for drawing
important conclusions regarding present scenario and future forecasting is very important and growth
determining practice of pharmaceutical industries. Intellectual property rights (IPR) is an integral part
of the industry and IPR related information is freely available in public patent databases. By
analyzing patents company can derive important conclusion regarding competitor’s R&D activities,
quality of research, collaboration and alliance and can convert this information to knowledge which
can play important role in taking future decisions. Present review is fully focused on advent of IPR in
getting very good information regarding competitor’s strategies and tactics.
DEPARTMENT OF PHARMACEUTICAL SCIENCES
SUMMARY TABLE ON TOUR REPORT
OF
B. PHARM. VI SEM (3RD YEAR)
EXIT ACCOMAN
ENTRY
NAME OF TIME YING
S. MANUFACU TIME IN
PLACE DATE DAY COMPAN FROM PERSON(S)
NO. RING UNIT COMPA
Y VISITED COMPA IN
NY
NY COMPANY
1 HYDERA 06/03/201 TUESDAY NIN RESEARCH 10:30 AM 15:15 MR. A.
BAD 8 INSTITUTE PM RAJANNA
OF & MR.
NUTRITIONS NASEER
2 HYDERA 06/03/201 TUESDAY SHREE API 16:30 PM 19:30 MR. RAJA
BAD 8 KRISHNA FORMULATI PM SEKHAR
ONS REDDY &
MR. T.
KRISHNA
3 HYDERA 06/03/201 TUESDAY SHREE API 16:30 PM 19:30 MRS.
BAD 8 KRISHNA FORMULATI PM REENA
ONS MAINAM
4 HYDERA 07/03/201 WEDNES DR. R&D UNIT 10:00 AM 01:00 MR.
BAD 8 DAY REDDY’S PM ABHINAV
LAB AGRAWAL
& MR.
BASANT
AMARJI
5 GOA 12/03/210 MONDAY CIPLA INHALATOR 10:00 AM 12:45 MR.
8 Y DOSAGE PM SANTOSH
FORMS DESHPAND
E
6 GOA 13/03/201 TUESDAY FDC SOLID 10:00 AM 12:50 MR.
8 DOSAGE PM SHAILESH
FORMS R.
GOVEKAR
Prof. Asmita Gajbhiye Patil
(Prof., Department of Pharmaceutical Sciences)
Mr. Rakesh Kashyap
(Guest Faculty, Department of Pharmaceutical Sciences)
Ms. Anamika Jain
(Research scholar, Department of Pharmaceutical Sciences)
DEPARTMENT OF PHARMACEUTICAL SCIENCES
TOUR REPORT
OF
B. PHARMA. VI SEM (3rd YEAR)
SESSION-2017-2018
SESSION: 2017-18 As a part of B. Pharm. curriculum the Industrial Tour of 10 days was completed
from 5th March 2018 to 14th March 2018. The Industrial Tour was accompanied by 3 faculties which
names are as follows:
1) Prof. Asmita Gajbhiye Patil (Prof. Department of Pharmaceutical Sciences)
2) Mr. Rakesh Kashyap (Guest Faculty, Department of Pharmaceutical Sciences)
3) Ms. Anamika Jain (Research Scholar, Department of Pharmaceutical Sciences)
During these 10 days of Industrial Tour, we visited 1 Institute of Nutritional Research & 5
Pharmaceutical Companies of different manufacturing units & R&D section in Hyderabad & Goa. We
started our journey Industrial Tour from Sagar at 05:30 AM on 5th March 2018 for Bina via Bus (New
Radha Roadways) and reached railway station of Bina at about 07:30 AM. From Bina we moved to
Hyderabad via Dakshin Express (Train No. 12722) at about 11:45 AM, the train was late for about 4
hours. In the early morning of 6th March 2018 around 05:45 AM we reached Hyderabad. From 6th
March 2018 we started our Industrial visit in Hyderabad. We first visited National Institute of Nutrition
(NIN) Tarnaka from 10:30 AM to 15:15 PM on 6th March 2018, where we learned about the targets,
achievements and opportunities in the field of nutrition. We also visited Centre for Animal Studies
which is also at NIN campus. In NIN we are thankful to Mr. Rajanna & Mr. Naseer for their precious
time spent with us and for providing necessary informations & arrangements. After NIN visit we
moved forward to Shree Krishna Pharmaceuticals, where we got the knowledge about API
manufacturing and granulation. In Shri Krishna Pharmaceuticals we spent around 3 hrs., from 16:30
PM to 19:30 PM. We appreciate the valuable work of Mrs. Reena Mainam done for us.
On the next day i.e. 7th March 2018 we visited Dr. Reddy’s Lab (R&D unit), from 10:30 AM to 01:00
PM, where we knew about the challenges, research methodology, mentality of researchers working
culture of research wing. We are very thankful to Mr. Abhinav Agrawal & Mr. Basant Amarji and their
colleagues for their healthy discussion & arrangements. Thus, in Hyderabad we visited one National
Institute of Nutrition, 2 API formulations units of Shri Krishna & R&D unit of Dr. Reddy’s Lab. After
visiting in Hyderabad, we moved forward to Goa for next part of Industrial tour.
On 8th March 2018 we left Hyderabad about 11:00 PM via HYB KOP Express (Train No. 11303)
reached on Londa junction at about 04:00 PM. Then after from Londa, we travelled by Karnataka
Roadways Buses to Madgaon (Goa). In Goa due to Saturday & Sunday and audit in most of the
companies we could not get permission to visit.
Then on Monday i.e. 12th March first we visited Inhalation manufacturing unit of Cipla 10:00AM to
12:45 PM. Where we saw the new device for inhalation i.e syncobreath which is a dose controlled and
dose calculating device. We are very thankful to Mr Santosh Deshpande for a well-planned visit of
students.
Then on 13th March 2018 we visited FDC which is a solid dosage form manufacturing unit, where we
visited different section of solid dosage form like raw material storage, quarantine area, granulation
section, punching section, in-process check section, quality control section, packaging section, finished
dosage form storage section. We are grateful to Mr. Shailesh R. Govekar (Plant Manager) for a well-
planned visit of students.
In our Industrial visit we visited National Institute of Nutrition, API manufacturing plant of Shri
Krishna Pharmaceutical & R&D unit of Dr. Reddy’s in Hyderabad and Inhalation manufacturing
National Institute of Nutrition and Research
The Institute was founded in 1918 by Sir Robert McCarrison. It was originally a single room laboratory
at the Pasteur Institute, Coonoor, Tamil Nadu for the study of Beriberi, and was called the Beri-Beri
Enquiry Unit. McCarrison was invalided to Britain from 1920–1922, and in 1923 the
enquiry was axed on financial grounds. It was restored two years later as the Deficiency Disease
Inquiry, which McCarrison headed from 1925-1929. The scope of the laboratory expanded to include
all deficiency diseases, and around 1928-29 became the Nutrition Research Laboratories (NRL), with
McCarrison as its first Director, until his retirement in 1935, when he was succeeded by Dr. W.R.
Ackroyd. The facility moved to Hyderabad in 1958 and in 1969 was renamed the National Institute of
Nutrition
The institute carries out research and patent development in -
Clinical nutrition
Outcomes research
Pharmacology
Pathology
Food chemistry
Endocrinology
Molecular biology
Regenerative medicine
Community nutrition
Ophthalmology
Sports nutrition
Agencies such as WHO and FAO recognized the institute as a Centre for excellence in food
quality, safety and nutrition research. The institute is equipped with state of the art facilities
among Animal housing,
In vivo-imaging
Automated electrophoresis
Flow cytometry
DNA Microarray
Matrix-assisted laser desorption/ionization
Scanning electron microscope
Confocal laser scanning microscopy
Transmission electron microscopy
DNA sequencers
Cryogenic equipment
Thermal cyclers
The National Institute of Nutrition (NIN) is an Indian Public
health, Biotechnology and Translational research center located in Hyderabad, India. The
institute is one of the oldest research centers in India, and the largest center, under the Indian
Council of Medical Research, located in the vicinity of Osmania University. The institute has
associated clinical and pediatric nutrition research wards at various hospitals such as the Niloufer
Hospital for Women and Children, the Government Maternity Hospital, the Gandhi Medical
College and the Osmania General Hospital in Hyderabad.
The National Centre for Laboratory Animal Science (to be integrated into the National
Animal Resource Facility for Biomedical Research), and the Food & Drug Toxicology
Research
Centre, National Nutrition Monitoring Bureau are the other wings of NIN for India's Ministry
of Health and Family Welfare.[5] The institute also derives funding from the Indian Department of
Biotechnology. The institute majorly conducts research in obesity, diabetes, food
chemistry, dietetics, drug toxicology, and micronutrient deficiency in collaboration with centers
such as the Rockefeller University, University of Colorado School of Medicine, Washington
University, and the Johns Hopkins Bloomberg School of Public Health in the US and the
University of Wollongong
Shree Krishna API UNIT,Uppal
It is a pharmaceutical industry based upon the API Formulation. An active pharmaceutical
ingredient is defined as “any substance or mixture of substances intended to be used in the
manufacture of a drug product and that, when used in the production of a drug, becomes an
active ingredient in the drug product.
Different active pharmaceutical ingredients are formed here.
Acetaminophen (Paracetamol)
Domperidone
Domperidone Maleate
Folic Acid
Enalapril Maleate
Furosemide
Glibenclamide
Research And Development
Their laboratory is utilized for synthesis of process related impurities to support the analytical
work. here R&D Lab also has the capability to further characterize and certify the impurity
standards. there pilot plant (Kilo Lab), at Uppal is operational to translate the process capability
from laboratory scale to “Kilo” stage before taking up commercial production.
Analytical Capabilities
Independent analytical testing laboratories for each unit with adequate number of
gradient HPLCs/ UPLCs/ GC with head space in addition to the regular essential
laboratory equipment.
Cubical modules for each type of analysis
Separate teams for method development and validations.
Separate teams for stability monitoring for different climatic zones.
Chemistry Capabilities
High Pressure – Autoclave reactions
Grignard reactions.
Group photo at Shree Krishna Laboratory
DR REDDY’S LAB
The most prominent therapies that we focus on*:
Oncology
Cancer is a disease that requires specialized treatment and care at every stage. Having understood
patient and partner needs deeply, we have developed a broad range of high-quality cancer care
medications. Across the spectrum of cytotoxics, targeted therapies and supportive care, our range
is designed to effectively combat cancer and the side effects associated with the therapy.
Oncology is also the field where we’ve successfully demonstrated our cutting-edge research and
development capabilities. Among our numerous achievements is the development of the world’s
first recombinant human GCSF biosimilar protein, the world’s first bio-similar therapeutic
monoclonal antibody and the single source pegfilgrastim.
Gastrointestinal disease
Heartburn is a common symptom of Gastroesophageal reflux disease, a widespread
gastrointestinal disorder that is becoming increasingly prevalent worldwide.
Dr Reddy’s has developed a broad portfolio of acid suppressive medications to address this
widely prevalent and debilitating disease. Our portfolio consists of some of the leading brands,
including our flagship brand OMEZ. In addition, Dr. Reddy’s has a varied portfolio that
addresses various other gastrointestinal disorders such as irritable bowel, diarrhea and
constipation, both in adults and children. We have recently ventured into Hepatology segment to
address the patient needs of Hepatitis B and Hepatitis C, providing affordable medications to
more people.
Cardiovascular
Changing lifestyles and dietary patterns are causing an unprecedented surge in the incidence of
cardiovascular diseases. Hypertension is probably the most prevalent of these. In keeping with
changing patient needs, Dr Reddy’s has developed a wide and varied portfolio of anti-
hypertensive medicines to bring good health to the millions affected by this condition. Our
portfolio consists of a number of successful products including Amlodipine,
Amlodipine+Atenolol combination, ACE inhibitors like Enalapril as well as angiotensin receptor
blockers (ARBs) like Telmisartan.
Since patient compliance is crucial in controlling hypertension, our development focus has been
on improving convenience and comfort. This led us to create a number of innovations like
monthly packs of our Atorvastatin and Telmisartan products in India, for example.
Anti-Diabetic
Along with hypertension, diabetes is another rapidly growing lifestyle health condition, the
world over. Dr. Reddy’s has a number of established products like Metformin, Glimepride,
Glicazide and their combinations in its portfolio, to ensure good health to diabetics.
Many of our development efforts focus on initiatives to help improve patient compliance. For
example, we successfully developed a patient-friendly dosage form of Metformin that was easily
swallowed and helped the patient stick to the prescribed treatment regimen.
Dermatology
Dr Reddy’s has proven expertise to develop solutions for health conditions such as Seborrheic
Dermatitis, Psoriasis, Corticosteroid-responsive Dermatoses, various types of Dermatitis, Actinic
Keratosis, Rosacea, Warts and Acne. In fact, some of our over-the-counter (OTC) products in
trichology and hair regrowth are leading brands in their own right.
Our solutions go far beyond the pill. We have successfully developed and deployed patient-
programs that help patient compliance, especially in conditions like Acne.
Pain Management
Dr. Reddy’s has several established products – both generic and branded generic – that address a
wide range of pain conditions. Products such as Nise, our brand of Nimesulide, is one of the top
300 brands in the Indian pharmaceutical market, for instance. Apart from Nimesulide, we have
several other products including Ketorolac and Hyaluronic acid that form a significant part of our
portfolio. Our development effort focuses on creating newer combinations as well as exploring
new delivery mechanisms to improve patient comfort, convenience and efficacy.
Group Photo at DRL
CIPLA PHARMACEUTICALS PVT LTD * CIPLA PHARMACEUTICALS PVT LTD
It was founded by Khwaja Ahmed Hamied as 'The Chemical, Industrial & Pharmaceutical
Laboratories' in 1935 in Mumbai.The name of the Company was changed to 'Cipla Limited' on
20 July 1984. In the year 1985, US FDA approved the company's bulk drug manufacturing
facilities.Led by the founder’s son Yusuf Hamied, a Cambridge-educated chemist, the
companyprovided generic AIDS and other drugs to treat poor people in the developing world. In
1994, Cipla launched Deferiprone, the world’s first oral iron chelator.In 2001, Cipla offered
medicines for HIV treatment at a fractional cost.
* Formulation Developement
Formulation pipeline has 250+ complex products where >75% is development for International
markets majorly in Respiratory, Oncology, ARVs, Ophthalmology, CNS, CVS etc. Cipla’s
development lab is equipped with state-of-the-art infrastructure for development of innovative
technology products.
* API Development
Active Pharmaceutical Ingredients - API Cipla houses state-of-the-art research facilities for its
API process development at three locations in India, with dedicated teams working on synthetic,
organic chemistry, process engineering and analytical development at multiple locations.
• API pipeline consists of complex developments in the therapy areas of Oncology, Hep
C, ARV, Diabetology, CVS, CNS, Respiratory etc.
Cipla uses latest technologies like process analytical technology, continuous flow
reactors for process development.
The products are developed using principles of quality by design, incorporating design of
experiments (DOE) to develop robust and cost-effective processes.
API R&D has dedicated oncology and polypeptide development labs.
* Dosage Form and Disease Cured –
Cipla is proud of its commitment to respiratory diseases with the introduction of Salbutamol
inhaler in 1978 in India. Since then we have consistently introduced new products for asthma,
Chronic Obstructive Pulmonary Disease (COPD) and Allergic Rhinitis (AR) and more recently
in other diseases such as Pulmonary Arterial Hypertension (PAH), lung cancer and Idiopathic
Pulmonary Fibrosis (IPF). dedication to Respiratory shows in how our scientists work tirelessly
to develop easier-touse inhaler devices, combination products and devices for monitoring airway
diseases. You see evidence of it in the many world firsts we have developed in this therapy. In
the incomparable work we have done with the medical fraternity to shatter myths, spread
awareness and empower patients to lead fuller lives.
Group photo at Cipla PVT
FDC is a pharmaceutical company Goa, an integrated pharmaceutical company – with worldclass
API and formulation capabilities – They offer a wide range of formulations, as well as APIs.
Besides our oral solid and oral liquid formulations, their expertise in ophthalmic and Oral
Rehydration Salts (ORS) dosage forms gives extensive reach and penetration across continents.
Their competence in product development, regulatory expertise and manufacturing built over
several years of relentless efforts have made them a preferred supplier to global customers
including non-profit organizations like UNICEF, IDA, MSF and PSI.
Dosage Forms Manufactured -
Dosage forms are pharmaceutical medication item in the frame in which they are advertised for
utilize, with a particular blend of dynamic fixing and dynamic segments, in a particular setup for
example tablets, containers, capsules. is one type of physical dosage form. These drugs are
mainly administrated orally in dry state.
Some of the dosage forms of solids are shown below:
• Tablets
• Capsules
• Powder
Tablet
A tablet is a hard, compressed medication in round, oval, square or many other shapes. Strong
measurements frames contain unit dosage of at least one medicaments (2,3). There are different
types of tablets. They are:
Tablets taken orally:
Compressed tablet
Multiple compressed tablet
Repeat action tablet
Delayed release tablet
Sugar coated tablet
Film coated tablet
Chewable tablet
Tablets used in oral cavity:
Buccal tablet
Sublingual tablet
Troches
Dental cone
Capsules
A capsule is a medication in a gelatin shell. There are 2 types of shells. They are:
Hard shelled capsules
Soft shelled capsules
Hard shelled capsule: These capsules are utilized generally for dry powdered ingredients.Soft
shelled capsule: These capsules are utilized for oils or for dynamic fixings that are suspended or
dissolved in oils.
Powder
A solid dosage form of which medicament is meant for both internal and external use. These are
available in both amorphous and crystalline form (7).
Powders are classified as:
Bulk A pharmaceutical powder is a mixture of finely divided drugs and chemicals in the
dry
form. This is powders meant for internal use
Bulk powders meant for external use
Simple and compound powders meant for internal use
Powders enclosed in cachets and capsules
Bulk powders meant for internal use: The powders which are utilized internally is said to be
bulk powders for internal use.
Bulk powders meant for external use: These are non-potent substances which are meant for
external purpose. These powders are said to be bulk powders for external use. Simple and
compound powders meant for internal use: In this form of powders, each individual dose is
enclosed in paper. The ingredients used may be single (Simple) or more (compound).25
Powders enclosed in cachets: Cachets are the solid unit dosage form of drug. These are utilized
to place the powders. These are also called as wafer capsule.
Product Name with site of action
AMLODIPINE Tablets Cardiac (Antihypertensives, CCB)
ACECLOFENAC dispersible Tablets Orthopaedics
ACECLOFENAC + THIOCOLCHICOSIDE Capsules Anti-Rheumatics(NSAIDS with
skeletal muscle relaxants)
6. SUMMARY
ummary of Industrial Visit
Industrial visit has its own importance in career of a student who is pursuing a professional
degree. It is considered as a part of B.Pharma curriculum. In all we visited seven pharmaceutical
companies of different manufacturing units including R&D. We have been benefitted a lot by
seeing the industries. What we are studying theoretically, saw all the practical process of
manufacturing at large scale. We also understood the working environment of pharmaceutical
companies. Over all we were satisfied with the knowledge we gained in those ten days. While
visiting these industries we have made use of time to the maximum possible. The industrial visit
has also created a team spirit and cordial relations among all of us. It has also nurtured the
student- teacher relationship.
6.2 Summary on Sites Visited other than Industries
A Visit to Wonderla –
Wonderla Hyderabad offers 25 land based rides and 18 water based attractions on 50 acres of
land.[14] Wonderla Amusement Park is located 28 km away from Hyderabad City.
Saral Jung Museum
The Salar Jung Museum is an art museum located at Darushifa, on the southern bank of the Musi
River in the city of Hyderabad, Telangana, India. It is one of the three National Museums of
India.[2] It has a collection of sculptures, paintings, carvings, textiles, manuscripts, ceramics,
metallic artefacts, carpets, clocks, and furniture
from Japan, China, Burma, Nepal, India, Persia, Egypt, Europe, and North America. The
museum's collection was sourced from the property of the Salar Jung family. It is one of
the largest museums in the world.
Char Minar
The Charminar ("Four Minarets"), constructed in 1591, is a monument and mosque located
in Hyderabad, Telangana, India. The landmark has become a global icon of Hyderabad, listed
among the most recognized structures of India. Charminar has been a historical place with
mosque on the top floor for over 400 years and also famous for its surrounding markets. It is one
of the tourist attractions in Hyderabad. It is where Many local festivals are celebrated in
Charminar area like Ramzaan. The Charminar is situated on the east bank of Musi river.To the
west lies the Laad Bazaar, and to the southwest lies the richly ornamented granite Makkah
Masjid. It is listed as an archaeological and architectural treasure on the official "List of
Monuments" prepared by the Archaeological Survey of India. The English name is a
translation and combination of the Urdu words Chār and Minar or meenar, translating to "Four
Pillars"; the eponymous towers are ornate minarets attached and supported by four grand arches.
Church
Then after we moved to Catholic church and bought one pair of candles. The practice of lighting
candles is an important tradition in Catholic churches, communities and families Candles lighted
before Christ’s image also shows our reverence to Him who deserves our adoration and thanks
giving and who alone can forgive our sins and bring us back into a deeper relationship with Him.
Scarry House & Aquarium
At 10th march we all students visited this horror house and aquarium that was full of different
categories of fishes and marine lives.
Dolphin Visit
At 11th march we visited Dolphin Lake that was surrounded with dolphins and we also saw that
place here that was used for shooting purpose in different movies scene.
Beaches
At 10 and 11th march same day we visited different beaches such as bagha beach.
Cruise visit
on 12 March we visited cruise after visiting beaches. cruise was such a best memorable visiting
place that our class enjoyed in the whole life…that was full of dance, singing and other activities
that we enjoyed a lot and that was the bestest moment of our all lifes.
We returned home safely and happily