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Spreading Hope and Happiness through Quality, Affordable Healthcare
Contact Us
Active Pharmaceutical Ingredients (API) Business
India/Rest of the World
Glenmark Generics Ltd.
Glenmark House, B D Sawant Marg, Chakala
Off Western Express Highway, Andheri (East)
Mumbai 400 099, India
T: +91 22 4018 9999
North America/Australia/New Zealand
Glenmark Generics Inc., USA
750 Corporate Drive, Mahwah, NJ 07430
T : (201) 684-8000
European Union
The Old Sawmill
Hatfield Park, Hatfield
Hertfordshire AL9 5PG, UK
T:+44 1707 630900
Glenmark Generics (Europe) Limited
Latin America
Glenmark Generics Ltd
Rua Frei Liberato de Gries, 548
Jardim Arpoador, São Paulo – SP, Brazil
CEP: 05.572-210
T: +55 11 5504 2700
Finished Dosage Formulations Business
North America
Glenmark Generics Inc., USA
750 Corporate Drive, Mahwah, NJ 07430
T: (201) 684-8000
European Union
The Old Sawmill, Hatfield Park
Hatfield, Hertfordshire AL9 5PG, UK
T:+44 1707 630900
Glenmark Generics (Europe) Limited
Oncology Business
Argentina
Address: Calle 9 Ing. Meyer Oks N° 593
Parque Industrial Pilar, fracción IV,
parcela 7D (B1629MX) Pilar, Bs. As.,
Argentina T: 54-2322-529555
Glenmark Generics S.A.
Glenmark Generics Ltd.
Glenmark House, B D Sawant Marg, Chakala,
Off Western Express Highway, Andheri (East)
Mumbai 400 099, India
T: + 91 22 4018 9999
Corporate Office
1
Glenmark Generics Ltd - An Introduction 2
Businesses 4
Manufacturing Facilities 10
Research & Development 12
People 14
Compliance, Quality & Intellectual Property 16
Awards & Recognitions 20
GPL - The Parent Company 18
Table of Contents In a world where disparities in healthcare are increasingly prevalent,
Glenmark Generics believes that good health is meant for all.
It strives to meet this objective by making medication affordable,
transcending all boundaries and demographics.
Glenmark Generics Ltd. endeavours to make high quality and
affordable healthcare a reality for all!
Is there an answer to -
Spiraling healthcare costs?
Inequities in healthcare access?
Cost-effective universal healthcare?
Achievement
Respect
Knowledge
A
tnemeveihc
To emerge as a leading integrated
global generics organization
Our vision
Our values
3
Spreading Hope and
Glenmark Generics Ltd
Happiness
Pioneering a movement – High Quality Affordable Healthcare
Driven by its vision, Glenmark Generics Ltd. (GGL) has structured its businesses as US
Generics, European Generics, the Active Pharmaceutical Ingredient (API) business
and the Oncology Business.
A subsidiary of Glenmark Pharmaceuticals Limited, GGL focuses on developing,
manufacturing, selling and the distribution of generics through wholesalers, retailers
and pharmacy chains.
From APIs to front end marketing capabilities, GGL's businesses are vertically
integrated into the generics market, by focusing on key niche segments including
Dermatology, Hormones, Controlled Substances, Oncology and Modified Release
Products.
The company's revenue for the Financial Year 2010 stood at an impressive Rs. 10,500
Mn. (USD 219 mn).
A major contributor to sales is the US Generics Business which presently contributes
around 70% to the overall revenue, supplemented by the API business which
contributes around 25% to the overall revenue.
Businesses Business - FDF
Touching millions of lives
across the globe
GGL
ActivePharmaceutical
Ingredients(API)
Finished Dosage
Formulations(FDF)
OncologyNorth America
Europe
5
Our rewarding businesses across geographies
US Business - Among the top 25 Generics
organizations in the US.
* As per US-IMS data
US GENERICS
Glenmark Generics Inc., USA (GGI) is the North American division of Glenmark Generics Ltd.
Glenmark made the strategic decision to enter the world’s largest pharmaceutical market by
establishing its subsidiary in the United States in 2003. Since its first product launch in
January 2005, the Company has emerged as one of the leading generic organizations in the
country. The business has grown at a consistent rate with a robust portfolio of products that
has doubled almost every year.
A focused presence in niche segments including dermatology, hormones, controlled
substances, and modified release products has helped ensure a sustainable market
opportunity and continued profitability. Glenmark’s approach to pipeline development has
always included a combination of filing opportunities. A key driver for the business is the
paragraph IV strategies which have resulted in successful outcomes such as first to file
status, market exclusivity and partnership opportunities within the pharmaceutical market.
GGI continues to rely on its strong foundation and makes use of research and marketing
initiatives to strengthen its presence in focused therapeutic segments.
Highlights include:
Among the Top 25 Generics organizations in the US*
The largest contributor to the revenue of Glenmark Generics Ltd.
A marketing portfolio of over 60 products currently sold in the market
Over 50 products filed with US FDA for approval
Strategic partnerships for controlled substances, dermatology and oral solid products
®Sole First to File opportunities : Zetia , Tarka , Cutivate Malarone & Locoid Lipocream ® ® ® ®
Business - FDF
The operations in Europe are built on three
revenue streams – sales through own front
ends, dossier licensing income and third party
commercial supplies.
Glenmark Generics (Europe) Ltd (GGEL) is the European subsidiary of GGL engaged
in marketing, licensing and distribution of generic products throughout Europe.
GGEL operates through its own sales infrastructure in the UK, Germany and the
Netherlands and through licensing and distribution arrangements in other European
Markets. The operations in Europe are built on three revenue streams - sales
through own front ends, dossier licensing income and third party commercial
supplies.
GGEL has an exciting portfolio of 48 approved Marketing Authorizations (based on 11
product formulations) across EU markets and 83 Marketing Authorizations
Applications (based on a further 10 finished product dossiers) under review by
various EU regulatory authorities. (As of 16th November 2010).
GGEL aspires to be recognized as an emerging pharmaceutical company in Europe
offering high quality and differentiated generic products. The product portfolio
reflects a healthy mix of solid orals and semi-solid products enabling access to niche
segments and opportunities in high volume products through vertically integrated
projects.
A UK based business development, regulatory and project management team is
supported by the intellectual property group, product development and
manufacturing infrastructure in India for key components of the development,
submission and support strategy in Europe.
7
ONCOLOGY BUSINESS:
Our oncology business, based in Buenos Aires, Argentina, serves as the hub for
generic research, manufacture and distribution of oncology products for the entire
organization. The process began with Glenmark’s acquisition of an Argentine oncology
company, Servycal S.A in 2005. This was followed by investing in a state-of-the-art
oncology manufacturing facility which was commissioned in 2009.
Our facility, along with our team of qualified professionals, pharmacists and physicians
has positioned the business as an important player in oncology in the Latin and Central
America region. Today, we have a presence in the oncology segment in several
countries, and plans to initiate oncology filings in regulated markets.
Highlights include:
Presence in oncology in over 20 countries
Caters to about 75% of cancer therapy products
Presence in cytotoxics, anti-hormonals and supportive therapies
Glenmark's API business spans over 80 countries including regulated markets such as
the US and Europe. Our vision is to be a preferred partner with leading global generic
companies by supporting partnerships through advanced process chemistry skills and
innovative Intellectual Property.
Glenmark Generics has established a direct presence of sales teams in key markets of
US, UK, Brazil and India supporting our corporate focus and commitment to global
regulated markets.
Glenmark is the market leader in many API products in semi-regulated markets and in
just a short period, has established leadership position in regulated markets in several
products. GGL has enjoyed a compounded average growth of 25% over the last three
years and is poised for higher growth as a number of key product patents expire in the
next few years.
Highlights include:
Over 50% of revenue is from exports with several supplies to regulated market
customers for first to file ANDAs
Contributes 20% to overall sales of Glenmark Generics Limited
Market Leader in regulated markets viz. Perindopril, Lercanidipine & Topiramate
Leadership in semi-regulated markets in Bupropion & Cilostazol
Filed over 164 process patents, 41 DMFs in the USA, 22 DMFs & 13 CEPs in Europe
and 13 DMFs in Canada
9
Business - API
API BUSINESS:
Manufacturing Facilities
11
Crucibles of
excellence
Our unmatchable manufacturing capabilities
Our commitment to uncompromising, world-class quality standards is reflected in our
state-of-the-art manufacturing facilities located across the globe. A snapshot of the
facilities-
Goa, India:
Three facilities for the manufacturing of Oral Solids, Semi Solids & Hormones
Over 110 products are manufactured at these facilities
The only hormone manufacturing facility in India approved by the US-FDA
Caters to the requirements of North America & Europe regions
Gujarat & Maharashtra, India:
3 API manufacturing facilities in Ankleshwar, Kurkumbh & Mohol
Over 90 APIs are manufactured at these facilities
Ankleshwar also services the requirements of regulated markets
Approvals from US-FDA, MHRA, KFDA and WHO for the Ankleshwar facility
Buenos Aires, Argentina:
The new oncological manufacturing facility spread across 30,000 sq ft is the company's
global hub for the manufacture of Lyophilized & Liquid Injectibles used in oncology
therapies. It caters to the requirements of at least 20 countries.
Indore, India
A state-of-the-art manufacturing facility at Pithampur, Indore is in the process of being
commercialized in CY 2011 to cater to the requirements of North America & Europe
regions. Currently, it is manufacturing exhibit batches for ANDA approvals. The initial
capacity of this facility is planned at 1 mn capsules/tablets per annum.
Our facilities are approved by various regulatory
bodies such as the US-FDA, UK-MHRA, WHO-GMP,
Canadian TPD, South African MCC & ANVISA of Brazil.
We have initiated the process for receiving the ISO
14001: 2004 certification, the internationally
recognized standard for environmental management,
for our Goa & Ankleshwar plants.
Research & Development
Our R&D Team: An enviable mix of priceless talent and unflinching commitment
13
Searching for Tomorrow’s
breakthroughs
We have spared no effort in setting up
cutting-edge facilities and employing the
sharpest brains in the business.
GGL has always appreciated the role of R&D in an industry such as ours. Consequently,
we have spared no effort in setting up cutting-edge facilities and employing the
sharpest brains in the business. Our R&D team is committed to delivering a
comprehensive catalog of prospects for filing of ANDAs & Drug Master Files as well as
registration dossiers & CEP for the European Market. And no doubt, they have
delivered amazing results!
Here are some highlights of our R&D facilities:
State-of-the-art integrated R&D Centre in Taloja (India) spanning 170,000 sq ft for
developing Active Pharmaceutical Ingredients and Formulated products
Clinical Research Unit spread over 15,000 sq ft in Navi Mumbai, India to separately
conduct Clinical Research activities, including Bioequivalence & Bioavailability
activities
R&D team of 300 scientists focused on process research development,
formulations development, analytical and clinical research
People
15
The secret to oursuccess story
The endless zeal and dedication of our people
Over 300 scientists, more than 450 employees
in API operations, over 650 in Formulations
operations and nearly 200 in support functions.
The employee base has grown... from just a few
hundred to over 1600 employees in the last few
years.
To achieve a turnover of USD 200 million in just a few years is indeed a tremendous
achievement. We owe this success to our employees for operating in a unified manner
focusing on the interests of the organization which has led to extraordinary results.
Our employees have authored our success story and will be most influential for our
growth in future. With over 300 scientists, more than 450 employees in API operations,
over 650 in Formulation operations and nearly 200 in support functions, Glenmark
Generics Limited has people from over six nationalities. Transcending all cultural
barriers, our people are at the heart of the organization, ensuring that we operate in
an integrated manner, focusing first on the interests of the organization.
For us, quality and compliance are non negotiable. In fact, it is our unwavering
commitment to quality and a refusal to compromise that forms the backbone of our
company. We have built a remarkable reputation with our customers and regulatory
agencies around the globe and will continue to do so in our bid to stay ahead.
Operating in highly quality-conscious markets, we have been relentless in stepping up
our quality systems across all our research and manufacturing facilities ensuring that
our products, processes, and infrastructure all measure up to international
expectations.
Regular training programmes for our people guarantee that they will implement higher
standards by the day.
In all the countries where we market our products, we work ceaselessly not only to
meet the stringent regulations but also to set new benchmarks.
17
Compliance, Quality & IP
Intellectual Property Registration (IPR) is a testament to the kind of work we are
doing. We have made tremendous progress which has led to a commendable number
of IPRs for the organization.
Glenmark Generics has a total of 166 patent applications and 9 granted patents in its
patent portfolio, which covers its innovations in the field of API & NDDS.
Glenmark’s granted patents cover the innovative and cost-effective processes of
manufacturing active ingredients like Rosuvastatin, Tazarotene, Oxacarbazepine,
Aprepitant, Lercanidipine HCl and their Novel polymorphic forms.
Intellectual Property: Leading through discovery
Building a Future
based on Trust
Compliance & Quality: Driven by commitment
Glenmark Pharmaceuticals Ltd
19
Charting a New Way
for a New WorldGlenmark Generics Limited is a subsidiary of Glenmark Pharmaceuticals Limited. GPL
is a research driven, global, integrated pharmaceutical company.
A leading player in the discovery of new molecules - both NCEs (New Chemical Entity)
& NBEs (New Biological Entity), Glenmark Pharmaceuticals Limited holds the
distinction of having 8 molecules in various stages of clinical development. The
company has a significant presence in branded generics markets across emerging
economies including India.
All Molecules in clinical development are 'First in Class' or 'Best in Class'
Three R&D centres exclusively for drug discovery
Branded generic business spans across 50 countries
An enviable number of 12 manufacturing facilities in 4 countries along with 5 R&D
centres and offices in over 30 countries
The innovation led parent company
Awards & Recognition
BEST PHARMA COMPANY IN THE WORLD-SME - 2008
BEST COMPANY IN EMERGING MARKETS - 2008
'BEST UNDER A BILLION' COMPANIES IN ASIA - PACIFIC REGION 2008
'EMERGING COMPANY OF THE YEAR' THE ECONOMIC TIMES AWARD
WINNER WINNER
21
A Testimonial to the kind of work
we do
Awarded the ‘Best Pharma Company in the
World - SME - 2008’ and ‘Best Company in
Emerging Markets - 2008’ by SCRIP - The world’s
leading Pharmaceutical Magazine.
Honoured and humbled by awards and recognitions
The passion for achievement, the quest for knowledge sets us apart. Here are a few
accolades we have received which acknowledge our success:
‘Thomson Reuters Innovation Award'
India's most innovative SME in Life Sciences, 2009
SCRIP, the world's leading pharmaceutical magazine crowned Glenmark the
'Best Pharma Company in the World-SME' and the 'Best Company in Emerging
Markets - 2008' at the SCRIP Awards 2008 in London.
Glenmark was chosen by Forbes, a leading business publication in the world, as
among the 'Best Under a Billion' Companies in Asia 2008.
‘Emerging Company of the Year'
The Economic Times Awards for Corporate Excellence, 2007