Hetero

A

Project report

ON

“AWARENESS AND TREATMENT TRENDS AMONGST GENERAL

PHYSICIANS ABOUT BENIGN PROSTATE HYPERPLASIA (BPH) AND OVER

ACTIVE BLADDER (OAB)”

For

HETERO HEALTHCARE LTD.

In partial fulfillment of the requirements of

Master of Management Studies

Conducted by

University of Mumbai

Rizvi Institute of Management Studies & Research

Under the guidance of

Prof. Rajesh Vyas

Submitted by

Zeeshan Kamruddin Shaikh

MMS

Batch: 2014 – 2016.

ACKNOWLEDGEMENT

The research on “Awareness and Treatment trends amongst General Physicians

about Benign Prostate Hyperplasia (BPH) and Over Active Bladder (OAB)”

IT has been given to me as part of the summer project from Hetero Healthcare Ltd. I have

tried my best to present this information as clearly as possible using basic terms that I

hope will be comprehended by the widest spectrum of researchers, analysts and students

for further studies.

I am highly indebted to Prof. Rajesh Vyas for his guidance and constant

supervision as well as for providing necessary information regarding the project & also

for their support in completing the project.

I would like to express my gratitude towards employee of Hetero Healthcare Ltd.

for their kind co-operation and encouragement which help me in completion of this

project.

I would like to express my special gratitude and thanks to Ms. Bella Barve of

Hetero Healthcare Ltd. for giving me such attention and time.

I am grateful to all faculty members of Rizvi Institute of Management and my friends

who have helped me in the successful completion of this project.

CERTIFICATE

This is to certify that Mr. Zeeshan Kamruddin Shaikh, a student of Rizvi Institute of

Management studies and Research, of MMS III bearing Roll No. 121 and specializing in

Marketing has successfully completed the project titled

“Awareness and Treatment trends amongst General Physicians about Benign

Prostate Hyperplasia (BPH) and Over Active Bladder (OAB)”

Under the guidance of Prof. Rajesh Vyas in partial fulfillment of the requirement of

Master of Management Studies by the University of Mumbai for the academic year 2014

– 2016.

______________

Prof. Rajesh Vyas

Project Guide

______________ ______________Prof. Umar Farooq Dr. Kalim KhanAcademic Coordinator Director

TABLE OF CONTENT

Sr. No Particulars Pg. No

1 Executive Summary 1

2 Background of Pharma Industry 4

3 Introduction to Hetero Healthcare Limited 7

4 SWOT Analysis of Hetero Healthcare 37

5 SWO T Analysis of Pfizer Limited 39

6 Data Analysis & Interpretation 41

7 Questionnaire & Analysis 42

8 Findings 51

9 Strategy 52

10 Conclusion 53

11 Bibliography 54

LIST OF TABLES

Particulars Page No.

Table 1: Products/Drugs by Hetero Healthcare Ltd 17 -29Table 2: Technical Packages by Hetero Healthcare Ltd 30-32

LIST OF FIGURES

Particulars Page No.

Figure 1: Count of Patients Suffering from BPH & OAB 42Figure 2: Diagnostic Procedure for BPH 43Figure 3: Diagnostic Procedure for OAB 44Figure 4: Line of Treatment 45Figure 5: Molecules used by GP’s for BPH 46Figure 6: Molecules used by GP’s for OAB 47Figure 7: Dosage and Period Molecule for BPH 48Figure 8: Dosage and Period Molecule for OAB 49Figure 9: Awareness among GP’s regarding BPH & OAB 50

Awareness and Treatment trends amongst General Physicians about Benign Prostate Hyperplasia (BPH) and Over Active Bladder (OAB)

1Rizvi Institute of Management Studies & Research

EXECUTIVE SUMMARY

Hetero drugs Limited (Hetero) is a research based pharmaceutical company. It undertakes

the research, development, manufacturing and marketing of active pharmaceutical

ingredients (APIs), intermediate chemicals and finished dosages. The company focuses

on the development and manufacturing of bio-generics and offers custom research and

manufacturing services (CRAMS) to global biotech and pharmaceutical companies.

Hetero owns and operates through its 18 manufacturing facilities that are approved by the

US FDA, Spanish Agency of Medicines & Health care products, WHO-Geneva,

ANVISA-Brazil, and IDA-Netherlands, among others. It markets its products in more

than 138 countries across the globe. Hetero is headquartered in Hyderabad, Telangana,

India.

Hetero Drugs Limited – Pharmaceuticals & Healthcare – Deals and Alliances Profile

provides you comprehensive data and trend analysis of the company’s Mergers and

Acquisitions (M&As), partnerships and financings. The report provides detailed

information on Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture

Financing and Partnership transactions recorded by the company over a five year period.

The report offers detailed comparative data on the number of deals and their value

categorized into deal types, sub-sector and regions.

This project is conducted to study about popular molecules used in a treatment of Benign

Prostate Hyperplasia (BPH) and Over Active Bladder (OAB):

Benign Prostate Hyperplasia:

Benign Prostatic Hyperplasia (BPH) also called benign enlargement of the prostate (BEP)

or (BPE), adenofibromyomatous hyperplasia and benign prostatic hypertrophy is a

benign increase in a size of prostate.

BPH involves hyperplasia of prostatic stromal and epithelial cells, resulting in the

formation of large, fairly discrete nodules in the transition zone of the prostate. When



sufficiently large, the nodules impinge on the urethra and increase resistance to flow

of urine from the bladder. This is commonly referred to as "obstruction," although the

urethral lumen is no fewer patents, only compressed. Resistance to urine flow requires

the bladder to work harder during voiding, possibly leading to progressive hypertrophy,

instability, or weakness (atony) of the bladder muscle. Although prostate specific

antigen levels may be elevated in these patients because of increased organ volume

and inflammation due to urinary tract infections, BPH does not lead to cancer or increase

the risk of cancer.

BPH involves hyperplasia (an increase in the number of cells) rather than hypertrophy (a

growth in the size of individual cells), but the two terms are often used interchangeably,

even amongst urologists.

Adenomatous prostatic growth is believed to begin at approximately age 30 years. An

estimated 50% of men have histological evidence of BPH by age 50 years and 75% by

age 80 years; in 40-50% of these men, BPH becomes clinically significant. BPH was one

of the ten most prominent and costly diseases in men older than 50 years of age in a study

in the United States.

Over Active Bladder:

Overactive bladder (OAB), also known as overactive bladder syndrome, is a condition

where there is a frequent feeling of needing to urinate to a degree that it negatively affects

a person's life. The frequent need to pee may occur during the day, at night, or both. If

there is loss of bladder control than it is known as urge incontinence. More than 40% of

people with overactive bladder have incontinence. While about 40% to 70%

of incontinence is due to overactive bladder. It is not life-threatening. Most with the

condition have problems for years.

The cause of overactive bladder is unknown. Risk factors include obesity, caffeine,

and constipation. Poorly controlled diabetes, poor mobility, and chronic pelvic pain may

worsen the symptoms. People often have the symptoms for a long time before seeking

treatment and the condition is sometimes identified by caregivers. Diagnosis is based on a

person's signs and symptoms and requires other problems such as urinary tract



infections or neurological conditions to be excluded. The amount of urine passed during

each urination is relatively small. Pain while urinating suggests that there is a problem

other than overactive bladder.

Overactive bladder is estimated to occur in 7-27% of men and 9-43% of women. It

becomes more common with age. Some studies suggest that the condition is more

common in women, especially when associated with loss of bladder control

A survey was conducted wherein primary data was collected from General Physician

(MBBS) to understand how frequently Doctors deal with such patients, the survey was

conducted for 40 days in the areas of western and central Mumbai wherein Doctors

feedback was taken.

The observation from the survey was female Doctor don’t treat the patients of Benign

Prostate Hyperplasia. Tamsolusin with the combination of Dutasteride is used largely for

both the disease whereas these molecules are in market since past 10 years.

The most commonly observed symptoms for Benign Prostate Hyperplasia (BPH) were

Micturition, Nocturia, Urge Incontinence, Haemeturia and inflamed urination.

The most commonly observed symptoms for Over Active Bladder (OAB) were urgency

in urination, micturition, frequent urination, Increased frequency of urination.



BACKGROUND OF PHARMA INDUSTRY

Exports of pharmaceutical products from India increased from US$6.23 billion in 2006–

07. The pharmaceutical industry in India is the world's third-largest in terms of volume.

According to the Department of Pharmaceuticals of the Indian Ministry of Chemicals and

Fertilizers, the total turnover of India's pharmaceuticals industry between 2008 and

September 2009 was US$21.04 billion. The domestic market was worth US$12.26

billion. The industry has a market share of $14 billion in the United States.

According to the India Brand Equity Foundation, the Indian pharmaceutical market is

likely to grow at a compound annual growth rate (CAGR) of 14-17 per cent in between

2012-16.India is now among the top five pharmaceutical emerging markets of the world.

The government began encouraging the growth of drug manufacturing by Indian

companies in the early 1960s, and with the Patents Act in 1970. This patent act removed

composition patents from foods and drugs, and though it kept process patents, these were

shortened to a period of five to seven years.

The lack of patent protection made the Indian market undesirable to the multinational

companies that had dominated the market and as they left, Indian companies carved a

niche in both the Indian and world markets by reverse-engineering new processes for

manufacturing low-cost drugs. Although some of the larger companies have taken baby

steps towards drug innovation, the industry as a whole has not changed its business

model.

In 2009-10, India's biopharmaceutical industry grew at 17 percent, with revenues of Rs.

137 billion ($3 billion). Bio-pharma was the biggest contributor, generating 60 percent of

the industry's growth at Rs. 88.29 billion, followed by bio-services at Rs. 26.39 billion

and bio-agriculture at Rs. 19.36 billion.

In 2013, there were 4,655 pharmaceutical manufacturing plants in India, employing over

345 thousand workers.



Challenges:

Even after the increased investment, market leaders such as Sun Pharma and Dr. Reddy’s

Laboratories spent only 5–10% of their revenues on R&D, lagging behind Western

pharmaceuticals like Pfizer, whose research budget last year was greater than the

combined revenues of the entire Indian pharmaceutical industry.

This disparity is too great to be explained by cost differentials, and it comes when

advances in genomics have made research equipment more expensive than ever.

The drug discovery process is further hindered by a dearth of qualified molecular

biologists. Due to the disconnect between curriculum and industry, pharma in India have

so far lacked the academic collaboration that is crucial to drug development in the West.

Pharmaceutical and Biotechnology:

Unlike in other countries, the difference between biotechnology and pharmaceuticals

remains well-defined in India. Bio-tech there still plays the role of pharma’s little sister,

but many outsiders have high expectations for the future. India accounted for 2% of the

$41 billion global biotech market and in 2003 was ranked 3rd in the Asia-Pacific region

and 11th in the world in number of biotech. In 2004-5, the Indian biotech industry saw its

revenues grow 37% to $1.1 billion. 75% of 2004–5 revenues came from bio-

pharmaceuticals, which saw 30% growth last year. Of the revenues from bio-

pharmaceuticals, vaccines led the way, comprising 47% of sales. Biologics and large-

molecule drugs tend to be more expensive than small-molecule drugs, and India hopes to

sweep the market in bio-generics and contract manufacturing as drugs go off patent and

Indian companies upgrade their manufacturing capabilities.

Most companies in the biotech sector are extremely small, with only two firms breaking

100 million dollars in revenues. At last count there were 265 firms registered in India,

over 75% of which were incorporated in the last five years. The newness of the

companies explains the industry’s high consolidation in both physical and financial

terms. Almost 50% of all biotech are in or around Bangalore, and the top ten companies

captured 47% of the market. The top five companies were homegrown; Indian firms



account for 62% of the bio-pharma sector and 52% of the industry as a whole.[4,46] The

Association of Biotechnology-Led Enterprises (ABLE) is aiming to grow the industry to

$5 billion in revenues generated by 1 million employees by 2009, and data from the

Confederation of Indian Industry (CII) seem to suggest that it is possible.



INTRODUCTION TO HETERO HEALTHCARE LIMITED

Hetero is a research based global pharmaceutical company focused on development,

manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate

Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a

tradition of excellence and deep sense of commitment in developing cost effective

processes to offer wide range of affordable drugs.

Hetero is building on the strengths of vertical integration in discovery research, process

chemistry, API manufacturing, formulation development and commercialization. Hetero

is a leading international supplier with a rich portfolio of over 200 products from wide

range of therapeutic categories both in active pharmaceutical ingredients and finished

dosages.

Hetero’s manufacturing facilities are cGMP compliant meeting global standards in terms

of infrastructure and systems. Majority of them are approved by the various regulatory

authorities of USFDA, WHO-Geneva, Australian TGA, Spanish agency of medicines &

health care products, ANVISA-Brazil, IDA-Netherlands etc.,

With full-fledged marketing capabilities, the company has been able to market its

products in over 138 countries across the globe.



FOUNDER

Dr. Bandi Parthasaradhi Reddy, Chairman & Managing Director of Hetero group is

academically endowed with a Post Graduate and Doctoral degrees with distinction in the

field of synthetic chemistry. Prior to founding of Hetero Drugs Limited, Dr. B.P.S Reddy

had a stint in leading pharmaceutical companies as the head of the Research &

Development division. His sharp analysis and ability to synthesize various chemical

compounds lead to the discovery of new processes, cost effective schemes for

manufacturing of various pharmaceutical products. During the said period Dr.B.P.S

Reddy has the credit of introducing many new molecules for the first time in Indian

pharmaceutical market.

A visionary the world knows as Dr. B.P.S.Reddy, is the driving force behind this growing

pharmaceutical phenomenon called “HETERO”. Dr.B.P.S.Reddy’s dream child, Hetero

was born in the year 1993 as a small API unit. Today, 17 years later, the name is

synonymous with leadership in pharmaceuticals with more than 18 manufacturing units

and 8000 employees. An entity that is grown in stature by virtue of its combined strength

in research, manufacturing and marketing.

Dr. B.P.S.Reddy steered Hetero towards the forefront of global pharmaceutical industry

with his vision to be recognised as an aggressive company that combines its strength of

R&D and manufacturing with definite advantages in terms of cost and chemistry with a

strong emphasis on quality of the products.

Dr. B.P.S.Reddy is now focusing on giving new dimensions to Hetero in terms of

research and innovation programs in discovery research to take the company to greater

heights.



AWARDS AND ACCOLADES

Hetero has been scaling new heights on a continual basis. These achievements have been

the result of concerted efforts on the part of different functions within the organisation to

achieve the organisational goal of being a leader.

In its path to success, Hetero has seen many a milestone being crossed and achieved

many awards on various fronts. Awards for exemplary work in R&D and marketing are

just a few to name.

A track of few events that saw Hetero reaching its Zenith of glory is:

2009

∑ Top Pharmexcil Gold Patent award.

∑ Top Pharmexcil Outstanding Export Performance award in Drugs and

Pharmaceuticals.

2006

∑ Chemexil Trishul export award for outstanding export performance 2001

Excellence & National Integration award in recognition of the efforts for

excellence with affairs connected with educational specialties and creating

teaching skills besides promoting harmony at all levels in the college.

1999

∑ Highest exporter award against stiff competition from internationally recognized

domestic competitors.



1998

∑ Top Chemexil award for Exports.

1996

∑ National award for "Best Efforts in Research and Development" from the

Department of Scientific and Industrial Research, Ministry of Science and

Technology, Government of India, in the year 1996.

GLOBAL PRESENCE

Hetero exports its products across different regions USA, Canada, Europe, Japan, Latin

America, Africa, Middle East, Far East, Australia, Russia & CIS, in the world and is

catering to the requirements of around 138 countries in the world.

CORPORATE SOCIAL RESPONSIBILITY

Corporate Social Responsibility is our commitment

Hetero Group always believes in the concept of giving back to the society to uplift the

living standards in the surrounding society as one of the prime responsibilities and always

took the lead. The Group is committed for implementation of various CSR initiatives and

contributes substantially to the cause.

Hetero Group received appreciation from the Government of Andhra Pradesh, for its

outstanding contribution in the implementation of Corporate Social Responsibility. .

Environment Protection:

∑ Completed One Million Plantation Programme.

∑ Taking up Plantation in the surrounding Schools.

∑ Completed Plantation in newly acquired 15 acres land and a total of 25000 Nos.

of saplings made.



∑ Provided substantial amount to the industrial association for the development of

infrastructure and environment in Kazipally IDA.

∑ Provision of Biomass Pellets for cooking purpose in place of LPG gas.

Social Welfare Programs:

Hetero recognizes its obligations towards the society and as a socially responsible

organization, we strive to take care of the less privileged sections of our society. We

extend our expertise to transform the lives of our people and make a difference to the

society. In this initiative, Hetero has adopted few villages for their overall development.

∑ Education

∑ Sports

∑ Medical

∑ Rural Development

1) Education: Hetero assists in setting up of schools for children in the vicinity of the

plants, where there is no access to education facilities, providing financial

assistance to the poor students who have promising academic record and adopts

schools for the following support:

∑ Infrastructure: Construction and renovation of schools, classrooms, libraries,

provision of amenities like class room benches, tables and chairs, sanitation

facilities and constructing compound walls for the surrounding schools.

∑ Distribution of booksand reading materials to the school libraries along with

books and uniforms to the school going children.

∑ Awarding of Merit scholarships to students and provision of free technical

education in engineering on the eligibility basis.



2) Sports: Sponsors athletes from various educational institutions to participate in

National and International level competitions, organises sports camps and events in many

villages.

3) Medical: Hetero conducts periodical medical camps at various locations in socially

backward areas to provide timely medical assistance to the needy. Hetero also contributes

for the construction of health centers and has liberally donated medicines to the

Government of India, Government of A.P. and to various Hospitals.

4) Rural Infrastructure: Hetero adopts villages, for all round development of

infrastructure, like roads, drainages, sanitation, electricity, sponsors religious activities &

constructions and provides safe drinking water facilities, with the installation of R.O.

water purification systems.

BUSINESS FOCUS

Active Pharmaceutical Ingredients

Hetero is one of the largest manufacturer and supplier of Active Pharmaceutical

Ingredients (API’s) catering to the ever increasing requirements of the global

pharmaceutical market.

The infrastructure available with Hetero for manufacturing of Active Pharmaceutical

Ingredients and the intermediate chemicals is one of the best, with State-of-the- Art

facilities designed to meet the global standards and cGMPs.

With 11 API manufacturing facilities in operation, Hetero has been able to manufacture

more than 200 APIs, and supply to different markets. 6 of the API facilities are approved

by USFDA, TGA, EU, PMDA, KFDA and WHO.



Hetero is a trusted supplier of several APIs in wide range of therapeutic categories and

the largest supplier of complete range in Antiretroviral products.

Hetero also has dedicated facility for manufacturing of Oncology products.

RESEARCH & DEVELOPMENT

Research & Development is the foundation of Hetero’s philosophy of developing cost-

effective, high quality and safe medicines to society. Hetero Research Foundation is one

of the most innovative, productive, and respected a scientific research organization which

is recognized by the Department of Science & Technology, Government of India.

Hetero Research Foundation (HRF) has a team of over 400 dedicated scientists working

in the areas of Process, Analytical and Discovery Research. R & D centre conforms to

international Standards and has advanced equipment for both basic and applied research.

Process R&D

HRF has developed process for 150 plus molecules for various markets. The R&D team

actively involved in process development, scaling-up technology transfer and associates

with manufacturing team throughout life cycle of product.HRF has always been

emphasizing to ensure that the processes being adopted for the products are cost

effective, safe to handle and with optimum advantage in terms of yield and quality.

Analytical R&D

Analytical research at HRF is equipped to conduct complete physical and chemical

characterisation of API’s/ NCE’s. Further, the team is well versed with regulatory filings

and has vast experience in documentation. The infrastructure includes advanced

instruments like LC-MS-MS, GC-MS, NMR, Powder XRD apart from several HPLC

systems.



MANUFACTURING INFRASTRUCTURE

Hetero group as a whole has 18 Manufacturing facilities at various locations

encompassing manufacturing of Active Pharmaceutical Ingredients and Finished Dosage

Products.

Committed to quality, safety and environment, most of our manufacturing facilities have

been inspected and approved by the US FDA, WHO-Geneva, Spanish Agency of

Medicines & Health care products, ANVISA-Brazil, IDA-Netherlands etc.,

API Facilities

1. Hetero Drugs Ltd.

∑ Unit I (Bonthapally):

API Manufacturing Facility for Regulatory Markets – USFDA Approved

∑ Unit – IV (Bonthapally)

API Manufacturing Facility for Non-Regulatory & Domestic Markets

∑ Unit VI (Vizag Non SEZ):

API Manufacturing Facility for Domestic Market & Semi-Regulatory Market

∑ Unit VIII (Bonthapally - EOU):

API Manufacturing Facility - EOU

∑ Unit IX (Vizag SEZ):

API Manufacturing Facility for Semi- Regulatory & Regulatory Markets



2. Hetero Labs Ltd.

∑ Unit – I (Kazipally):

API Manufacturing Facility for Regulatory Markets – USFDA Approved

∑ Unit – III (Vizag Non SEZ):

API Manufacturing Facility for Domestic Markets

∑ Unit – IX (Vizag SEZ):

API Manufacturing Facility for Regulatory Markets–USFDA Approval under

consideration

Formulation Facilities

1. HETERO LABS LTD.

∑ Unit – III (Jeedimetla):

Finished dosage manufacturing facility for regulatory markets – USFDA, WHO,

ANVISA, GCC, ISO, MCC, Pharmacy Medicine and Poisons Board-MALAWI,

AEMPS & UAE Approved

∑ Unit – V (Baddi):

Finished dosage manufacturing facility for Indian market

∑ Unit – II (Baddi):

Finished dosage manufacturing facility for semi-regulatory & Indian markets

∑ Unit – V (Jedcherla):

Solid & Liquid finished dosage manufacturing facility for semi-regulatory &

regulatory markets - US FDA, WHO, PICS/GMP Approved



∑ Unit – VI (Jedcherla):

Dedicated Oncology finished dosage manufacturing facility for semi- regulatory

& regulatory markets - USFDA, PPB-Kenya, NDA-Uganda, NoMA –Europe

(Norway), Zimbabwe, Namibia, Botswana, Malawi, ANVISA (Brazil) Tanzania,

TFDA (Taiwan), Ethiopia, Mexico & Belarus (MOH) Approved



PRODUCTS

API's - Regulated Market

Drugs Master Files

API Name Status

Acyclovir USDMF/EDMF

Adefovir Dipivoxil USDMF/EDMF

Alfuzosin Hydrochloride USDMF/EDMF

Alvimopan USDMF

Amlodipine Besylate USDMF/EDMF

Aripiprazole USDMF/EDMF

Atomoxetine HCl USDMF/EDMF

Atorvastatin Calcium Amorphous & Crystalline USDMF/EDMF

Atovaquone USDMF/EDMF

Azilsartan Medoxomil USDMF/EDMF

Azithromycin Monohydrate USDMF/EDMF



API Name Status

Bupropion Hydrochloride USDMF/EDMF

Candesartan Cilexetil USDMF/EDMF

Celecoxib Form III USDMF/EDMF

Cilazapril EDMF/JPDMF

Citalopram HBr USDMF/EDMF

Clopidogrel Bisulphate Form I & Form II USDMF/EDMF

Colesevelam HCl USDMF/EDMF

Cyclobenzaprine HCl USDMF/EDMF

Dabigatran Etexilate Mesylate USDMF/EDMF

Desloratadine USDMF/EDMF

Dexlansoprazole USDMF/EDMF

Donepezil HCl Form I & III USDMF/EDMF

Dorzolamide HCl USDMF/EDMF

Doxazosin Mesylate EDMF

Doxercalciferol USDMF/EDMF



API Name Status

Duloxetine HCl USDMF/EDMF

Dutasteride USDMF/EDMF

Eletriptan Hydrobromide alfa Form USDMF/EDMF

Eltrombopag Olamine USDMF/EDMF

Entacapone Form A USDMF/EDMF

Eprosartan Mesylate USDMF/EDMF

Escitalopram Oxalate USDMF/EDMF

Esomeprazole Mg Dihydrate / Trihydrate USDMF/EDMF

Esomeprazole Sodium USDMF/EDMF

Etoricoxib Form I USDMF/EDMF

Ezetimibe USDMF/EDMF

Famciclovir USDMF/EDMF

Febuxostat USDMF/EDMF

Felbamate USDMF/EDMF

Fenofibrate USDMF



API Name Status

Fesoterodine Fumarate USDMF

Fexofenadine Hydrochloride Form I & II USDMF/EDMF

Finasteride Form I USDMF/EDMF

Fingolimod Hydrochloride USDMF/EDMF

Fosinopril Sodium USDMF/EDMF

Gabapentin USDMF/EDMF

Ganciclovir USDMF/EDMF

Glimepiride USDMF/EDMF

Hydralazine HCl USDMF/EDMF

Irbesartan USDMF/EDMF

Itraconazole USDMF/EDMF

Lacosamide Form I USDMF/EDMF

Lansoprazole USDMF/EDMF

Lercanidipine HCl EDMF

Levetiracetam USDMF/EDMF



API Name Status

Levofloxacin USDMF/EDMF

Lisinopril USDMF/EDMF

Loratadine EDMF

Losartan Potassium Form I USDMF/EDMF

Lurasidone Hydrochloride USDMF/EDMF

Metaxalone USDMF/EDMF

Milnacipran Hydrochloride USDMF/EDMF

Montelukast Sodium USDMF/EDMF

Moxifloxacin HCl Monohydrate / Anhydrous USDMF/EDMF

Memantine Hydrochloride Form I USDMF/EDMF

Nabumetone USDMF/EDMF

Nebivolol HCl EDMF

Olanzapine Form I & II USDMF/EDMF

Olmesartan Medoxomil USDMF/EDMF

Omeprazole Form A & Form B USDMF/EDMF



API Name Status

Omeprazole Magnesium USDMF/EDMF

Oseltamivir Phosphate USDMF/EDMF

Pantoprazole Sodium USDMF/EDMF

Perindopril Erbumine Alfa form USDMF/EDMF

Pioglitazone HCl USDMF/EDMF

Pitavastatin Calcium Form H1 USDMF/EDMF

Pramipexole Di HCl USDMF/EDMF

Prasugrel Hydrochloride Form B / Base USDMF/EDMF

Pregabalin USDMF/EDMF

Proguanil HCl USDMF/EDMF

Prulifloxacin USDMF/EDMF

Quetiapine Fumarate USDMF/EDMF

Rabeprazole Sodium USDMF/EDMF

Ramipril USDMF/EDMF

Raloxifene Hydrochloride USDMF/EDMF



API Name Status

Riluzole USDMF/EDMF

Risedronate Sodium USDMF/EDMF

Rivastigmine Tartrate / Base USDMF/EDMF

Rizatriptan Benzoate USDMF/EDMF

Roflumilast USDMF/EDMF

Rosuvastatin Calcium USDMF/EDMF

Rufinamide USDMF/EDMF

Saxagliptin Hydrochloride USDMF/EDMF

Sertraline HCl Form I & II USDMF/EDMF

Sevelamer Hydrochloride & Carbonate USDMF/EDMF

Sildenafil Citrate USDMF/EDMF

Simvastatin USDMF/EDMF

Solifenacin Succinate USDMF/EDMF

Silodosin Alfa Form USDMF/EDMF

Telmisartan USDMF/EDMF



API Name Status

Terbinafine HCl USDMF/EDMF

Tetrabenazine USDMF/EDMF

Tolvaptan USDMF/EDMF

Tolterodine Tartrate USDMF/EDMF

Topiramate USDMF/EDMF

Torsemide USDMF/EDMF

Trandolapril USDMF/EDMF

Valacyclovir HCl USDMF/EDMF

Valganciclovir USDMF/EDMF

Valsartan USDMF/EDMF

Vilazodone Hydrochloride Amorphous & Premix USDMF/EDMF

Voriconazole USDMF/EDMF

Zolmitriptan USDMF

Zonisamide USDMF

Ziprasidone HCl USDMF/EDMF



API Name Status

ANTIRETROVIRAL

Abacavir Sulphate USDMF/EDMF

Atazanavir Sulphate Type I & Form H1 USDMF/EDMF

Cobicistat USDMF/EDMF

Darunavir Amorphous & Ethanolate USDMF/EDMF

Didanosine USDMF/EDMF

Dolutegravir Sodium USDMF/EDMF

Efavirenz Form I & Form H1 USDMF/EDMF

Elvitegravir USDMF/EDMF

Emtricitabine USDMF/EDMF

Entecavir USDMF/EDMF

Etravirine Form I USDMF/EDMF

Fosamprenavir Calcium Form H1 & Amorphous USDMF/EDMF

Lamivudine Form I & Form II USDMF/EDMF

Lopinavir Form I & Amorphous USDMF/EDMF



API Name Status

Maraviroc Form B & Amorphous USDMF/EDMF

Nevirapine USDMF/EDMF

Raltegravir Potassium Form I & Amorphous USDMF/EDMF

Ritonavir Form I & Amorphous Premix USDMF/EDMF

Saquinavir Mesylate USDMF/EDMF

Stavudine USDMF/EDMF

Tenofovir Disoproxil Fumarate USDMF/EDMF

Zidovudine USDMF/EDMF

Boceprevir Technical Package

Indinavir Sulphate Technical Package

Nelfinavir Mesylate Technical Package

Rilpivirine Hydrochloride Technical Package

Telaprevir Technical Package

ANTINEOPLASTICS

Abiraterone Acetate USDMF/EDMF



API Name Status

Anastrozole USDMF/EDMF

Aprepitant USDMF/EDMF

Bendamustine Hydrochloride USDMF/EDMF

Bexarotene USDMF/EDMF

Bicalutamide USDMF/EDMF

Bortezomib USDMF/EDMF

Capecitabine USDMF/EDMF

Cyclophosphamide USDMF/EDMF

Docetaxel USDMF/EDMF

Erlotinib Hydrochloride Form A USDMF/EDMF

Fosaprepitant Dimeglumine USDMF/EDMF

Gefitinib USDMF/EDMF

Gemcitabine HCl USDMF/EDMF

Imatinib Mesylate Amorphous / Alfa Form / Beta Form USDMF/EDMF

Irinotrcan HCl USDMF/EDMF



API Name Status

Lapatinib Ditosylate USDMF/EDMF

Lenalidomide USDMF/EDMF

Letrozole USDMF/EDMF

Melphalan Hydrochloride USDMF/EDMF

Nilotinib Hydrochloride USDMF/EDMF

Paclitaxel USDMF/EDMF

Pazopanib Hydrochloride USDMF/EDMF

Pemetrexed Disodium 2.5 Hydrate / 7.0 Hydrate USDMF/EDMF

Plerixafor USDMF/EDMF

Pralatrexate USDMF/EDMF

Sorafenib Tosylate USDMF/EDMF

Sunitinib Malate USDMF/EDMF

Temozolomide USDMF/EDMF

Thalidomide USDMF/EDMF

Zoledronic Acid USDMF/EDMF



API Name Status

Azacitidine Technical Package

Carfilzomib Technical Package

Carboplatin Technical Package

Cisplatin Technical Package

Oxaliplatin Technical Package

Tamoxifene Citrate Technical Package

Vandetanib Technical Package

Table 1: Products by Hetero Healthcare Limited.



Technical Packages

API Name Status

Ambrisentan Technical Package

Avanafil Technical Package

Bosentan Technical Package

Brinzolamide Technical Package

Carglumic Acid Technical Package

Cevimeline Hydrochloride Technical Package

Cinacalcet Hydrochloride Technical Package

Cilnidipine Technical Package

Dalfampridine Technical Package

Dapagliflogin Technical Package

Deferasirox Technical Package

Desvenlafaxine Succinate Technical Package

Eplerenone Technical Package

Eslicarbazepine Technical Package



API Name Status

Gabapentin Enacarbil Technical Package

Ibandronate Sodium Technical Package

Ivabradine Hydrochloride Premix Technical Package

Linagliptin Technical Package

Naftopidil Technical Package

Olopatadine HCl Technical Package

Oxcarbazepine Technical Package

Pirfenidone Technical Package

Posaconazole Technical Package

Ramelteon Technical Package

Ranolazine Technical Package

Rupatadine Fumarate Technical Package

Sitagliptin Phospate Technical Package

Tadalafil Technical Package

Tofacitinib Citrate Technical Package



API Name Status

Trospium Chloride Technical Package

Vardenafil HCl Technical Package

Vigabatrin Technical Package

Table 2: Technical Packages by Hetero Heathcare Limited.

KEY PARTNERS

Global health group is engaged in research, development, manufacture and marketing of

healthcare products. The main activities according their importance and their turnover

are:

Pharmaceuticals (prescription drugs, consumer health, general medicine): aging diabetes,

rare diseases, oncology and other important products in the prevention of thrombosis,

cardiovascular disease, nephrology and biosurgery.

R&D to prevent, treat and cure disease. Constant innovation is very important in order to

attain his goal: answer to the real needs of patients and provide them appropriate

therapeutic solutions

Clinical Development Marketing & Distribution Creating value through partnerships

availability and performance of drugs.



CUSTOMER CHANNELS

Communication through Medical Institutions : hospitals, pharmacies, health personnel

(doctors) Communication through a website heterohealthcare.com and social media as

Facebook, Twitter, Android, iPhone and iPad app, YouTube Channels.

Hetero Healthcare has also developed a wide network of industrial sites. Commercial

presence in the world and multiple acquisitions and partnerships.

CUSTOMER SEGMENT

Physical Patients Health professionals: doctors, hospitals, pharmaceutical customer. Offer

training and services: Hetero assists health professionals throughout their careers and in

the evolution of their profession General public: self medication (one of the growth

platforms for Hetero) Veterinarians, farmers and pet owners Universities and students

(through training) Worldwide connected network of selected partners

Geographical Patients around the world Present in 100 countries and its products are

distributed in more than 170 countries Hetero is recognized in Emerging Markets, with

excellent positions in major countries.

CUSTOMER RELATIONSHIP

Innovation with the Doctors: Conference calls and Interactive learning sessions. Website

Destinated to all their clients worldwide, it helps Hetero Healthcare to defend a

healthcare and public utility image.



COST STRUCTURE

R&D is NOT the main cost item: They try to optimise their resources allocation in order

to maximize the R&D return on investment, Partnerships and Acquisitions: Investment

for 26 new transactions (8 acquisitions and 18 partnerships in R&D) Sales Force is the

1st cost item: Re-allocation by region and by products (less expenses on traditional

products but more on innovative ones)

Administrative and General Charges: Methodological following of these costs,

Communication and Publicity: By definition publicity is free and better for the

company’s image Ex: Press articles on the last Hetero’s innovation which will be able to

cure a rare diseases.

In emerging market the main cost are: Purchase of raw material Energy consumption of

the laboratories Work force

REVENUE STREAMS

Asset Sales type of revenue- Hetero provides innovative products and communication

related to those new medicines. The company contributes to the medicines promotion by

the States. Worldwide Net Turnover Shares: Domestic Market- 76%, International

Market-24%.



EVENTS

April'2010

Hetero launches one of the India’s largest finished dosage manufacturing facility in

Special Economic Zone (SEZ) at Jadcherla.

Hetero launches its new formulation facility (SEZ) at Jadchelra, Andhra Pradesh, India.

Strategically located just 60 kilometers from Hyderabad International airport off NH 7,

the project situated in the state’s first green industrial park.

The total unit area is 75 acres and with two manufacturing facilities. This facility offers a

huge production capacity of 18 billion tablets and capsules per annum. It has a dedicated

Oncology facility with a production capacity of 200 million tablets & capsules, 15

million liquid injectable vials & 15 million lyophilised Injectables.

This World-class facility is meeting the cGMP and regulatory requirements, with

integrated quality management system in place. All quality control Instruments are 21-

CFR compliant. Walk in type stability chambers with global requirements for stability

study and Integrated building management system from Honey well -USA , Lyophilizer

VIRTIS -USA, Liquid Filling machine from BOSCH – Germany, makes this

manufacturing facility at par with the best in the world.

April'2010

Hetero receives tentative approval for Tenofovir disoproxil fumarate tablets from

USFDA

Hetero is pleased to announce that it has received the tentatively approval for Tenofovir

disoproxil fumarate from the US Food & Drug Administration (USFDA).

Tenofovir tablets 300 mg is generic equivalent to Viread tablets 300 mg of Gilead

Sciences. Tenofovir belongs to a class of antiretroviral drugs known as nucleotide



analogue reverse transcriptase inhibitors (nRTIs), which block reverse transcriptase, an

enzyme crucial to viral production in HIV-infected people. Tenofovir is indicated in

combination with other antiretroviral agents for the treatment of HIV-1 infection in

adults.

Nov'2009

Hetero receives tentative approval of Lamivudine and Tenofovir fixed dose

combination tablets, 300mg/300mg tablets from USFDA

On November 5, 2009, using expedited review procedures developed to support the

President's Emergency Program For AIDS Relief (PEPFAR1), the US Food and Drug

Administration (FDA), granted tentative approval for lamivudine and tenofovir disoproxil

fumarate fixed dose combination tablets, 300mg/300mg.

The fixed dose combination product, indicated for use in combination with other

antiretrovirals for the treatment of HIV-1 infection.



SWOT ANALYSIS OF HETERO HEALTHCARE LIMITED

SWOT Analysis

Strength

1. Hetero Healthcare Ltd is world’s largest global producer of

anti-retroviral drugs for the treatment of HIV/AIDS.

2. Hetero Healthcare Ltd is recognized as a world leader in

process chemistry, API manufacturing, formulation

development, manufacturing and commercialization.

3. Hetero Healthcare Ltd is research-driven pharmaceutical

company.

4 is recognized as one of the top 10 companies in the Indian

pharmaceutical industry with an annual turnover of US$ 1.2

billion.

5. Hetero Healthcare Ltd has 15,000 employees.

6. Hetero healthcare manufactures high-quality drugs.

7. National award for "Best Efforts in Research and

Development" from the Department of Scientific and

Industrial Research, Ministry of Science and Technology,

Government of India, in the year 1996.

Weakness1. Controversies regarding issue of compulsion of licensing

in India



2. Patent expiry for a number of API products

Opportunity

1. Strategic agreements with other pharmaceutical companies

and organizations to boost its research.

2. Increasing awareness about healthcare needs

3. Increasing demand for quality healthcare solutions

Threats

1.Risk of unsuccessful new Products

2.Regulatory environment is becoming more & more

stringent

3.Economic slowdown in European markets

Competition

Competitors

1. Abbott Laboratories

2. Amgen

3. AstraZeneca

4. Bristol-Myers Squibb

5. Johnson & Johnson

6. Merck

7. Novartis

8. Pfizer

9. Roche Holdings

10. Sun Pharma



SWOT ANALYSIS OF PFIZER

SWOT Analysis

Strength

1. One of the largest pharmaceutical company in the world

and spread over more than 50 countries.

2. Excellent research and development (R&D) creating

innovative and breakthrough products

3. Mergers and acquisitions with big pharma brands

increasing brand reputation

4. Has over 100,000 employees as a part of the organization

5. Strong brand name and recall globally

Weakness

Tough competition from other major pharma brands means

limited scope for market share growth

Negative brand image due to involvement in largest

healthcare fraud of marketing its drug illegally

Opportunity

1.Strategic agreements with other pharmaceutical companies

and organizations to boost its research.

2. Increasing awareness about healthcare needs

3. Global penetration through mergers and acquisitions

4. Increasing demand for quality healthcare solutions

Threats1.Risk of unsuccessful new Products

2.Regulatory environment is becoming more & more



stringent

3.Economic slowdown in European markets

Competition

Competitors

1. Abbott Laboratories

2. Amgen

3. AstraZeneca

4. Bristol-Myers Squibb

5. Johnson & Johnson

6. Merck

7. Novartis

8. Roche Holdings

9. Sun Pharma

10. Hetero Healthcare



DATA ANALYSIS AND INTERPRETATION

I. Source of data: Primary

II. *Data collection Instrument: Direct interview through questionnaire

III. Sampling plan:

Time taken: 40 days

Area covered: Western and central Mumbai

IV. Observation: Female doctors don’t treat the patients of Benign Prostate

Hyperplasia, they treat mostly patients with Over Active Bladder.

Over Active Bladder is mostly misunderstood for the Urinary Tract Infection but

this case is only seen in females than in males. The differential diagnose of the

Over Active Bladder is Urinary Tract Infection.



QUESTIONNAIRE AND ANALYSIS

UROLOGY QUESTIONNAIRE

1. Do you see patients for Benign Prostatic Hyperplasia (BPH) and Over Active

Bladder (OAB)

BPH: Yes - 239 No – 33

OAB: Yes – 270 No – 2

Figure 1: Count of Patients suffering from BPH & OAB

Analysis:

Out of 272 respondent doctors, 239 treats patients for BPH and 33 don’t treat patients

for BPH & 270 treats patients for OAB and 2 do not treat patients for OAB.

0

50

100

150

200

250

300

BPH OAB

Yes

No



2. How do you diagnose patients for BPH and OAB?

BPH: USG – 243, PSA – 78, Clinical test – 47, KUB – 7, urine culture- 9

OAB: Cystometry – 79, USG – 187, Clinical test –46, Urine culture – 16,

Figure 2: Diagnostic Procedure for BPH

BPH

0

50

100

150

200

250

USG PSA Clinicaltest

KUB

BPH



Figure 3: Diagnostic Procedure for OAB

Analysis:

For BPH: 243 patients are diagnosed by USG, 78 by PSA, 47 by clinical test, 7 are

diagnosed by KUB.

For OAB: 187 patients are diagnosed by USG, 79 by Cystometry, 46 for Clinical test and

16 by Urine culture

.

OAB

0

50

100

150

200

USGClinical Test

Cystometry Urineculture

OAB



3. Do you treat patients by yourself or recommend to Urologist/Gen Surgeons?

Treat Self – 1

Recommend to Urologist - 19

Both – 252

Figure 4: Line of Treatment

Analysis:

252 Doctors said that they treat Self and then recommend the patients to urologist (Both),

19 Doctors recommends the patients directly to the Urologist, 1 treated by self, some said

it depends on cases-to- cases.

Treatment

0

100

200

300

Treat SelfRecommendto Urologist

Both

Treatment

Treatment



4. If the Doctors treat patients by himself then – How do you treat your patients

for BPH and OAB? (Name of the Molecule/single or combination)

Figure 5: Molecules used by GP's for BPH

BPH

020406080

100120140160

BPH

BPH



Figure 6: Molecules used by GP's for OAB

Analysis:

For BPH: For OAB:

Tamsulosin – 156

Tamsulosin + Dutasteride – 26

Finasteride – 10

Doxazosin – 6

Finasteride + Tamsulosin – 7

Prazosin – 1

Flavoxate – 57

Drotaverine – 27

Dutasteride – 12

Tolterodine – 66

Tamsulosin – 61

Fesoterodine – 6

Oxybutinin – 10

Trospium – 5

Tamsulosin + Dutasteride – 6

Solfinacen- 2

OAB

020406080

OAB

OAB



5. How long do you recommend the treatment for BPH and OAB patients?

(Few months or Lifelong)

Figure 7: Dosage and Period Molecule for BPH

BPH

020406080

100

BPH

BPH



Figure 8: Dosage and Period Molecule for OAB

Analysis:

For BPH: For OAB

Few months – 63

1 month – 93

2 months – 11

3 months – 18

6 months – 20

Life Long -10

Depends upon the cases – 19

Surgical Intervention -6

Few Months – 47

1 month – 40

2 month – 4

3 months – 4

6 months – 11

Lifelong – 88

Depends upon the cases –33

Refer To the Urologist – 2

OAB

0102030405060708090

Fewmonths

1 month 2months

3months

6months

Life Long Dependsupon the

cases

Refer tourologist

OAB

OAB



6. How do you update yourself for BPH/OAB for latest information on its

management?

CMES and Medical journal- 253

Internet – 95

Seminars – 9

Mobile app – 2

Figure 9: Awareness among GP’s regarding BPH & OAB

Analysis:

Out of 273 Doctors 253 update their self through CME’S and Medical Journals, 95

through internet, 9 through seminars and 2 Doctors through mobile app.

0

50

100

150

200

250

300

Cmes andMedical Journal's

Internet Mobile App Seminars



FINDINGS

∑ There are already many products containing Tamsulosin and Dutasteride in

market since past 10 years

∑ The product which is yet to be launched is already the leading brand of

competitors.

∑ Physician’s already prescribing this product so there are rare chances they will

write this product.

∑ Female Physician’s don’t treat the patients of Benign Prostate Hyperplasia (BPH)

which will further reduce the sales of this product.

∑ The competitors are very renowned Pharmaceutical Companies as compared to

Hetero Healthcare Ltd.

∑ The patients suffering from BPH and OAB are treated within the time period of 3

to 12 months.

∑ The most commonly observed are Nocturia, Haemeturia, Urge incontinence in

BPH patients, whereas, Urgency, Frequency, Micturition, Incontinence,

Incomplete emptying of Bladder are symptoms of Patient suffering from OAB.

∑ Physician’s Update themselves about these disease through CMES, Medical

Journals, Urology Seminars and sometimes Internet.

∑ Some Physician’s treat this disease themselves or refer to Urologist directly while

many Physicians first treat the patients themselves and if not cured than referred

to urologist.

∑ Some Physicians referred their patients to nephrologist only if surgical

intervention was necessary.

∑ The most commonly opted diagnostic methods were USG i.e. Ultra Sono Graphy,

PSA i.e. Prostate - Specific Antigen test, KUB test i.e. Kidney Ureter and Bladder

test before and after emptying the Bladder and Cystometry.

∑ Urinary Tract Infection was the differential diagnosis observed so maximum

times an antibiotic along with diuretic was prescribed.

∑ The most prescribed molecule by Physicians was Tamsulosin for both BPH and

OAB.



STRATEGY

∑ The product should be launched as per the Physicians and Retailers convenience

∑ The product should contain both the molecules, Tamsulosin and Dutasteride such

that one product will be used to treat both the disease.

∑ In order to beat the competitors the vital aspects like pricing, distribution channel,

retailer’s margin and Physicians convenience should be kept in mind.

∑ The product should be launched with a clear mindset of volume sales or Value

sales as later decision might prove to be fatal.

∑ Before launching the product, awareness should be created by distribution of free

samples among the Physicians and the retailers.

∑ As this similar molecule is in market since past 10 years so the product power,

product efficacy, shelf life should be elevated than the competitor products which

will give the reason to the retailers to stock the product without the fear of

expiration.

∑ Physicians should be provided with vital reasons and percussions to write the

product, as without their prescriptions product will not move efficiently in the

market.



CONCLUSIONS

Creating awareness at this stage when the other Pharmaceuticals Companies already have

this molecule in market is nothing but the risky decision.

To elevate the sales the product should be established as a brand first, as per the survey

the product is too old to launch in the market.

The product has certain hazardous side effects which is one factor of slow moving of this

molecule since past 10 years.

The survey was conducted at General Physician’s level however; this product is actually

meant for the Nephrologist and Urologist platform.

General Physicians cover only 5 to 6 patients per month so launching this Product at

General Physicians level might prove to fatal.

This molecule is used only for the long term treatment and from survey it is evident that

General Physicians are prescribing this molecule for 3 to 12 months.

Many patients do not visit the General Physician again if they are not cured and satisfied

with the treatment given hence the Physician doesn’t knows whether the patient is cured

or he is consulting the specialist.

From this entire survey I conclude that the product is not fit to be launched under such

circumstances as the product doesn’t have any uniqueness as compared to the

competitor’s product, it doesn’t have any such innovative combination or molecule which

will enhance the sales.



BIBLIOGRAPHY

∑ www.heterodrugs.com

∑ Essentials of Pharmacotherapeutics by F.S.K. Barar – S. Chand Publishing.

∑ Rang and Dale’s Pharmacology.

∑ Text book of Medical Physiology by Guyton and Hall.

∑ www.wikipedia.com

∑ www.webmd.com

http://www.heterodrugs.com/

http://www.wikipedia.com/

http://www.webmd.com/

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