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PHARMA EXPORT EXCELLENCE HANDBOOK Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury Chief of Product Harit Mohanty BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja, Swati Rana New Delhi Prathiba Raju DESIGN
National Design Editor Bivash Barua Asst. Art Director Pravin Temble Chief Designer Prasad Tate Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar Senior Artist Rakesh Sharma Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East Marketing Team Rajesh Bhatkal Ambuj Kumar E Mujahid Ajanta Sengupta Nirav Mistry PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia Scheduling & Coordination Santosh Lokare
FOREWORD
TAKING WINGS
T
he India Pharma Inc growth story is buoyed up exports, which has been a very significant growth driver. Indeed, it has earned India the title of 'Pharmacy of the World'. In October this year, PHARMEXCIL forecast that generic exports were now growing at around 22 per cent per year, with India accounting for around 20-22 per cent of the world’s production, covering more than 60,000 brands and 60 therapeutic classes. This wide spread of therapeutic classes is one of the strategies that has paid out and many pharma companies from India are now reaping the rewards. But they cannot be complacent. Headwinds, political, economic and regulatory, in key export destinations are already impacting margins. Key global regulators have combined forces to enforce current Good Manufacturing Practices (cGMPs). Singed by defaults on the cGMP front, many pharma companies in India are revamping their manufacturing processes. There are simultaneous moves to secure the supply chain through efforts to implement serialization and track and trace protocols. The US Drug Supply Chain Security Act (DSCSA) and the Falsified Medicines Directive (FMD) of the European Union (EU), cover the two main export destinations of pharma exports from India, but each country has its own directive. Indian companies are at various stages of designing and implementing their serialisation strategies but there is no doubt that like the GMP challenge, TnT will have to be seen as an investment rather than a cost. In spite of these challenges, India Pharma Inc continues to expand and deepen its geographical footprint. Each company has tweaked its export strategy to suit its means and key strength areas. Whether it is the dexterous balancing of regulated, semi-regulated and emerging markets, choosing the therapeutic areas, or choosing entry strategies, there are many companies which are making their mark. To celebrate and highlight these success stories, Express Pharma presents the Pharma Export Excellence Handbook 2017 featuring 17 companies and their leaders, which are at the forefront of finished formulation exports. It is our tribute to the grit and ingenuity of the founders and members of these companies who have built Brand India Pharma across the world.
CIRCULATION Circulation Team Mohan Varadkar
VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com
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CONTENT
Pharma Export Excellence Handbook
08
Glenmark Pharmaceuticals
28
Panacea Biotec
48
Alembic Pharmaceuticals
12
Sanofi India
32
Fourrts
52
Marksans Pharma
16
Micro Labs
36
Rusan Pharma
56
20
Eisai, India
40
Shilpa Medicare
60
24
Indoco Remedies
44
ZIM Laboratories
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Bliss GVS Pharma
OPTEL Group
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GLENMARK PHARMACEUTICALS In a short span of 17 years, it has evolved into a successful global branded generics organisation; and built a reputation of being an innovationdriven organisation in a space dominated by global pharma giants
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G
lenmark Pharmaceuticals is a research-driven, global, integrated pharma company. It has a diverse pipeline with several compounds in various stages of clinical development primarily focussed in the therapeutic areas of oncology, respiratory, and dermatology. Headquartered in Mumbai, India, with US headquarters in Mahwah, NJ, Glenmark has improved the lives of millions of patients by offering safe, affordable medications since nearly 40 years. The company has a significant presence in branded generics across emerging economies including India. It also has a fast growing and robust US generics business. Glenmark employs over 13,000 people and has operations in over 80 countries. It has 16 manufacturing facilities across five countries and five R&D centres. Glenmark is currently ranked among the World’s Top 75 Pharma & Biotech companies (SCRIP 100 – 2017 Rankings). Among several prestigious awards and accolades, it has also received the Gold Patent Award 2011 in the categories of API formulations and export of bulk drugs (non-biologicals) by Pharmexcil.
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As a leading researchdriven, global and integrated pharma organisation, it is committed to making a difference in patients’ lives. Since its entry into the pharma industry in 1977, the company have emerged as a leading player in the discovery of novel molecules, both new chemical entity ( NCEs) and new biological entity (NBEs), and differentiated generic formulations. There are several molecules in various stages of
the threshold of an exciting phase - one that holds great promise. In a short span of 17 years, it has evolved into a successful global branded generics organisation; and built a reputation of being an innovation-driven organisation in a space dominated by global pharma giants. Over the years, the company has expanded its manufacturing footprint to 16 facilities across the world and augmented its international operations to build a strong
‘‘
ISince its entry into the pharma industry in 1977, the company have emerged as a leading player in the discovery of novel molecules, both NCEs and new NBEs, and differentiated generic formulations
pre-clinical and clinical development and are primarily focussed in areas of oncology, respiratory and dermatology. The company has improved the lives of millions of patients by offering safe and affordable medications for nearly 40 years. Strategic research and development form the basis of all our offerings and we have more than 13,000 employees from 60 nationalities dedicated to the goal of enriching lives across the globe. EXPANDING EXPORTS
Glenmark believes that it is on
overseas presence. Glenmark recruited the best talent who shared its vision of achieving new heights of success. Over the next decade, the company intends to unlock many new opportunities that will help it transform into a leading innovative global pharma company. STRATEGY FOR SUCCESS
The company plans to earn 30 per cent of its revenues from specialty and innovative products by 2025. Their innovation programme has begun to deliver results with
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new molecules, currently in different stages of development, in the three focus areas of oncology, respiratory and dermatology. In parallel, the company has grow in size and reach, expanding our manufacturing footprint and providing differentiated products to customers globally. While for much of the last decade or more, the company has built a robust base business in key markets such as India and the US, it is also busy creating a roadmap to navigate a more challenging future. The result is a strategy that allows us to open up multiple, profitable and sustainable revenue streams to take us to a new orbit over the next decade, and is robust enough to withstand market and regulatory turbulence. In future, Glenmark informs that its business will stand on three pillars: Global generics, Speciality, Innovative products. Global generics are already the mainstay of its business and will be so for the foreseeable future. Speciality will help the company move up the value chain to brand-name products in highly-regulated markets, a lucrative opportunity that will unlock a new, sustainable revenue stream for the company and build a defense against price erosion in
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generics. Innovative products show promise to not only act as game-changers from a business perspective but also improve the lives of countless patients battling life- threatening ailments such as cancer. Given how vast each of these verticals are, Glenmark has chosen to sharpen focus on three therapy areas: Oncology, Respiratory and Dermatology. In these therapy areas, Glenmark wants to straddle the entire value chain whether it is bulk drugs, formulations, vanilla and complex generics, their delivery systems, or novel
drugs and devices. What is common to each of these therapy areas is their substantial market potential and pockets of unmet need for solutions that are more economical, safer, more effective or more convenient. Their research and development skills, manufacturing and commercial capabilities, market-leading position and deep organisational experience in these therapies in multiple markets makes Glenmark wellpositioned to deliver on these focus areas.
EXPORTS PORTFOLIO Major export destinations: US, Rest of the World, Europe, Africa & Asia, Europe, Germany, UK, Czech Republic, Latin America Key export products: Mupirocin Cream, Gabapentin, Calcipotriene, Pravastatin, Atovaquone Proguanil, Ascoril, Candid Exports turnover in 2016-17: 5108.3 crores
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NURTURING INNOVATION
Glenn Saldanha is the Chairman & Managing Director of Glenmark Pharmaceuticals. He joined in 1998 as the Director and took over as the Managing Director & CEO in 2001. Saldanha oversees all operations of the organisation. During his tenure, he transformed Glenmark into a truly global organisation with revenue in excess of ` 9000 crores ($1.4 billion) and offices in more than 40 countries worldwide. Under his leadership, Glenmark has evolved from an Indian branded generics business, into a research-driven and innovation-led organisation. Saldanha’s vision is to discover, develop and take to market India’s first innovative drug for the entire world. Saldanha holds a bachelor’s degree in pharmacy from Mumbai University and is an MBA from the Leonard Stern School of Business at New York University. Prior to Glenmark, he has worked with Eli Lily, US and PriceWater House Coopers, US.
Glenn Saldanha Chairman & MD, Glenmark Pharmaceuticals
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SANOFI INDIA Since 1956, Sanofi has dedicated itself to making India a ‘healthier’ nation, by building expertise, capability and capacity
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S
anofi is a global healthcare company committed to improving access to healthcare and supporting the people we serve throughout their health journey. From prevention to treatment, Sanofi offers healthcare solutions in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions, consumer healthcare, established prescription products and generics. Sanofi employs more than 100,000
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people and enjoys a presence in over 100 countries, including India. EXPANDING EXPORTS
Sanofi has a strong industrial presence in India: two pharma manufacturing sites and two vaccine manufacturing sites; development centres for formulations and chemicals and
biotechnology; a chemistry site and 38 contract manufacturing organisations (CMOs). Incorporating the latest designs and processes in manufacturing, the sites (in Ankleshwar, Goa and Shantha in Hyderabad) are global sourcing units and managed by highly trained, experienced and committed teams. High quality compliance
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Sanofi now holds the status of a trading house and is proud to be one of the largest pharma exporters in India, and a leader amongst MNCs
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and cost competitiveness have made Sanofi’s Indian sites an important part of the global company’s industrial strategy. In India, the company commenced export operations with active pharmaceutical ingredients (APIs ) and finished formulations in the late 60s. Initially, the company’s exports of finished formulations were concentrated in fewer markets. However, in more recent years, Sanofi has built significant sales through exports to nearly 60 countries across the globe, including highly regulated markets like Australia, Germany and the UK. The export operations has received several performance awards, the most significant being the Niryat Shree from Federation of Indian Export Organisations (FIEO) and the Outstanding Export Performance awards from Pharmexcil. The AllStar insulin pen is an indigenous re-usable insulin delivery device which is exported by Sanofi India. Since 2013 the exports of AllStar has grown to 20 countries. The AllStar pen won international acclaim with the coveted GOOD DESIGN award for 2013, conferred by the Chicago Athenaeum: Museum of Architecture & Design and the European Centre for Architecture Art Design &
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Urban Studies. Sanofi now holds the status of a Trading House (Three Star Export House) and is proud to be one of the largest pharma exporters in India, and a leader amongst MNCs. STRATEGY FOR SUCCESS
The company has made
significant investments in capacity as well as compliance in recent years to meet the rising demand for quality products from within India and international markets. This augurs well for Sanofi’s aspiration to grow the export business in the years ahead.
EXPORTS PORTFOLIO Major export destinations: Germany, United Kingdom, Australia, Russia and Czech Republic Key export products: Paracetamol + codeine tablets, Metformin tablets, Festal dragees, Pentoxifylline (API), Articaine Hcl and Ramipril tablets Exports revenue in 2016-17:Rs 5816 mio
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SPEARHEADING SUCCESS
Dr Shailesh Ayyangar spearheads Sanofi’s presence in India and South Asia. His patientcentric approach, combined with an astute business acumen and farsightedness, has helped Sanofi transform from a modest pharma company in the country in early 2002, to a major diversified healthcare company serving the patients of South Asia. Dr Ayyangar joined Sanofi in 2002, and has been instrumental in growing the business organically as well as through various acquisitions. Prior to joining Sanofi, Dr Ayyangar held senior positions in SmithKline Beecham Pharmaceuticals and GlaxoSmithKline (GSK), in India and in Great Britain. In November 2016, for his outstanding achievements in business, and commitment to French-Indian relations, Dr Ayyangar was conferred with one of the highest civilian honours officier de l’Ordre national du Merite (Officer in the National Order of Merit) - on behalf of the Honourable President of France by H.E. Alexandre Ziegler – Ambassador of France to India. He has also received several awards and accolades from various other leading institutions. He was unanimously elected as the President of OPPI for four consecutive years from 2013-17.
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Dr Shailesh Ayyangar MD India and VP - South Asia, Sanofi
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MICRO LABS With a turnover of `2,500 crores that includes 40 per cent turnover from exports, Micro Labs is poised to achieve unparalleled status in the global pharma industry in the times to come
Sikkim Plant
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E
stablished in 1973, Micro Labs is a fully integrated pharma company, present across the entire pharma value chain from research and development, active pharma ingredients, finished formulations to marketing and distribution in India and overseas. All this, robustly backed by state-of-the-art manufacturing facilities and R&D centres that are at par with international standards, has placed the company amongst India’s fast growing transnational healthcare organisations. The company has a strong manufacturing base with 13 state-of-the-art manufacturing plants built to comply with the international requirements across all parts of India and manufactures over 80 per cent of the products in-house. It has three world-class R&D centres for development of generic and innovative products. In the Indian Pharmaceutical Market, Micro Labs is ranked 14th among prescriptions (as per SMSRC June 16) and 19th in sales (as per AWACS MAT July 16). Micro Labs has PAN India sales presence with over 5800 experienced field force covering over 250,000 doctors and 180,000 pharmacies. The company has strong focus in India and also is present in over
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40 countries with 3300 product registrations at various stages. With a turnover of ` 2,500 crores that includes 40 per cent turnover from exports, Micro Labs is poised to achieve unparalleled status in the global pharma industry in the times to come. The organisation’s most
important component, however, remains its 9200 dedicated employees. With state-of-the-art facilities and R&D centres designed to international standards, Micro Labs is poised to become a respected global brand in the pharma field. The company today, has 20 marketing divisions catering to
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With state-of-the-art facilities and R&D centres designed to international standards, Micro Labs is poised to become a respected global brand in the pharma field
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leading therapeutic segments such as cardiology, diabetology, pain management, dermatology, veterinary, neurology, etc. EXPANDING EXPORTS
Micro is well poised to achieve in the medium term a status of a big generic company in the global pharma space. The group has presence in over 40 countries including developed markets such as Europe, Australia, South Africa, Canada and the US, with ground level operations in 15 countries, exporting all major dosages in every therapeutic segment with 3,300 product registrations at various stages. Micro Labs has been in a continuous stage of growth ever since it’s founding years and continues to chart its course as a leader in the pharma vertical. The company has presence in over 30 countries with ground level operations in 15 countries, exporting all major dosages on most of the therapeutic segments. We are poised to have a quantum leap in our global operations, with implementation of our growth strategies. The company currently operates in various countries of Asia, Europe, America and Africa. Micro Labs has already established a strong presence in the US, UK, Russia, Ukraine, Nigeria, French West Africa, East Africa, Myanmar, Philippines, Vietnam, Thailand,
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Sri Lanka, etc. Latin America, North America, East Europe, Australia, New Zealand and North Africa are locations where the company is raising its flag. The company also has plans to spread its wings in countries like Canada, South Africa, UAE, etc. STRATEGY FOR SUCCESS
To complement its vision for global operations, the company has established wholly owned subsidiaries in the US, UK,
Germany, Australia and Nigeria. The company has representative offices in many other parts of the world . Micro Labs is engaged in developing top of the line pharma products, while adhering to highest quality standards by a world class research team. Today its state-of-the-art manufacturing facilities and infrastructure facilitate the company's organic growth in the regulated markets.
EXPORTS PORTFOLIO Major export destinations: US, UK, Russia, Ukraine, Africa, Myanmar, Philippines, Vietnam, Thailand, Sri Lanka, Latin America, North America, East Europe, Australia, New Zealand
Key export areas: Cardiology, Diabetology, Pain management, Dermatology, Veterinary, Neurology Exports turnover: ` 920 crores
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A DYNAMIC LEADER
Dilip G Surana currently serves as the Chairman and MD of Micro Labs. He has over 20 years of varied experience in the pharma industry. He took over the reigns from of his father, Late GC Surana in 1983. His younger brother Anand Surana joined him in the year 1993, and he currently holds the Director’s position in the company. The growth of Micro Labs has a lot to do with the vision and passion of these two brothers. The duo brought in fresh ideas and Micro Labs became one of the few companies in the mid-1980s to have separate strategic business units that focused on areas such as cardiology, neurology, dermatology and nephrology. Under Surana’s leadership, the company has introduced various molecules for first time in India. He also established world class state-of-the-art research and manufacturing facilities covering APIs and finished dosage forms as well as infrastructure for new drug discovery. Dilip Surana has been instrumental in setting up 14 state-of-the-art facilities for Micro Labs. Dilip Surana has been honoured time and again with prestigious awards. Business Leader presented by White Page International’.
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Dilip G Surana Chairman and MD, Micro Labs
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EISAI, INDIA Eisai India has set up a benchmark in the Indian pharma industry in exporting both drug substance and drug products to the stringent Japanese market. It has been exporting around 1.4 billion tablets and 20 tonnes of drug substance to Japan every year since 2012
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isai Co Ltd was the first Japanese company to have a 100 per cent subsidiary in Indian pharma market. Eisai Pharmaceuticals India (Eisai India) was incorporated in October 2004, with a registered office at Mumbai. It has an integrated facility at Vizag, set up to meet the pharma product needs of Japanese market and to improve Access to Medicine (ATM). Eisai India’s product portfolio includes prescription medicines in several therapeutic areas such as the central nervous system disorders, metastatic breast cancer, benign prostrate hyperplasia , muscle spasm, vertigo, gastrointestinal disorders, diabetes and peripheral neuropathy. Eisai India’s R&D team is collaborating globally with other R&D teams in US, Europe and Japan to develop and launch innovative new chemical entities (NCEs) to support unmet medical needs.
EXPANDING EXPORTS
Eisai India’s products are exported to the US, Europe, and Japan for clinical trials conducted across Eisai’s global locations. The company has been exporting the products manufactured at this facility for the past seven years and has
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since then set up a benchmark in the Indian pharma industry in exporting both drug substance and drug products to the stringent Japanese market. Eisai India has been exporting around 1.4 billion tablets and 20 tonnes of drug substance to Japan every year since 2012. These include products in the therapeutic areas of gastroenterology, CNS etc.
medicine in 107 low- to middleincome countries. Eisai is ranked 11th on the ATM Index. Eisai India’s Vizag facility manufactures drug substances (APIs), drug products (oral solid dosage forms-tablets) and carries out developmental research of active pharma ingredients (APIs). This facility is registered as a
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Eisai India has been a primary contributor to the progress of Eisai on the Access to Medicine (ATM) Index. The ATM Index is an independent initiative that ranks the world's 20 largest research-based pharma companies according to their efforts to improve access to medicine in 107 low- to middle-income countries. Eisai is ranked 11th on the ATM Index
The Pharmaceuticals Export Promotion Council of India (Pharmexcil) appreciated and honoured Eisai for their contribution and collaboration in strengthening mutual cooperation between India and Japan in the pharma sector in 2016. Eisai India has been a primary contributor to the progress of Eisai on the Access to Medicine (ATM) Index. The ATM Index is an independent initiative that ranks the world's 20 largest research-based pharma companies according to their efforts to improve access to
pharma manufacturer at regulatory agencies viz USFDA, PMDA, MHRA and WHO. The facility has also received the following certifications: ISO 14001:2004 for Environment management system (EMS), ISO 18001 (OHSAS) and ISO 27001 (Information security management system) from TUV SUD. Eisai India’s integrated facility is at the top of its performance through efficient plant utilisation for drug substance and finished products. The facility is on the verge of completion of site expansion to facilitate manufacturing and
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supplying of more products for exports. The research and manufacturing facility at Vizag has been at the centre stage of Eisai’s commitment to World Health Organization (WHO) for the free supply of DEC tablets for eliminating lymphatic filariasis. From 2013 till date, Eisai India has supplied 1.3 billion DEC tablets to 27 countries. The facility was also acknowledged by the Guinness Book of World Records for being part of the pharma partners for most medications done in 24 hours towards the elimination of neglected tropical diseases (NTDs). Eisai products are launched simultaneously both in India and abroad at the same time so that patients have earliest access to
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the medicine. STRATEGY FOR SUCCESS
Eisai India is currently undergoing expansion to manufacture innovative products to Eisai and also for other companies thus supporting the expansion of the public healthcare programme in Japan. Eisai India as a patient-centric organisation has the strategy to manufacture high quality
pharma products at affordable cost and supply them worldwide. This strategy is aligned with the prestigious 'Make in India' campaign launched by the Government of India. Eisai has invested around $20 million in the last two years to augment research as well as API manufacturing and also enhanced the warehousing capacity to support Make in India programme.
EXPORTS PORTFOLIO Major export destinations: US, Europe and Japan Key export products: DEC tablets, products in gastroenterology and CNS Exports turnover in 2016-17: `182.54 crores
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AN ASTUTE LEADER
Dr Sanjit Lamba, Eisai India’s Managing Director, is an astute business executive with cross functional experience of over 28 years in the pharma industry. Eisai’s integrated global manufacturing and research facility at Vizag, India, under the leadership of Dr Lamba, won the Facility of the Year Award (FOYA) from ISPE, US in 2012. His strong leadership with the ability to initiate change accomplished the greenfield project in Vizag’s Pharma City SEZ. Dr Lamba has been named three times to the list of '100 of the Most Inspiring People' in the lifescience industry by PharmaVOICE magazine, US. He has worked with companies like Lupin, Pfizer, Merck Sharp and Dohme etc. He has handled various functions including manufacturing, projects, commissioning/ qualification, drug regulatory affairs, quality assurance and supply chain management, etc. He is associated with Indian Pharmaceutical Association, International Society for Pharmaceutical Engineers (ISPE) and serves as President – India Chapter for Parental Drug Association (PDA). Dr Lamba also serves on the judging panel of ISPE headquarters, US.
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Dr Sanjit Lamba MD Eisai India
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INDOCO REMEDIES With one foot firmly entrenched in the fast growing Indian pharma market and the other in the vast international market, Indoco is poised to achieve greater heights
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ndoco Remedies, headquartered in Mumbai, is a fully integrated, researchoriented pharma company with presence in 55 countries. Indoco, a $165 million company, employs over 6000 people including over 300 skilled scientists. The company has nine manufacturing facilities, six for finished dosages and three for APIs, supported by a state-of-theart R&D centre at Rabale, Navi Mumbai and a CRO facility in Hyderabad. The facilities have been approved by various regulatory authorities such as, USFDA, UK-MHRA, SUKLCzech Republic, Cofepris – Mexico, TGA-Australia, JAZMPSlovenia, MCC-South Africa, NDA-Uganda, TFDA-Tanzania, SBD-Yemen, MOH-Ukraine, PPBKenya and FDB-Ghana. The company recently acquired an oral solid dosage (OSD) manufacturing facility located at Baddi from Micro Labs , Bangalore. The facility is spread over an area of 18,000 sq m. It produces 4.3 billion tablets and 50 million capsules p.a. Indoco develops, manufactures and distributes a wide range of pharma products for the Indian and international markets. It generates more than 70 million prescriptions annually from over 3,10,000 doctors in India. Indoco’s nine domestic marketing divisions
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cater to different therapeutic segments, including respiratory, anti-infectives, dental care, pain management, gastroenterology, opthalmic, cardiovascular, antidiabetics, anti-obesity, etc. Indoco exports a number of generic products in the regulated and emerging markets. Its branded formulations are promoted in
emerging Markets of South East Asia, Africa, Latin America and CIS countries. Indoco has major tie-ups with big generic companies and works in close coordination with its customers for leveraging core competencies. EXPANDING EXPORTS
Indoco commenced export
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The company’s export business has been growing steadily and accounts for almost 45 per cent of Indoco’s total revenues
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business in 2003, when it received its first UK MHRA approval for a solid dosage facility in Goa. This paved way for the company to export to the regulated markets. The company received its first contract for dossier development with the European company in the same year. All facilities have been approved by regulatory bodies like the USFDA, UK-MHRA, TGA-Australia, MCC-South Africa, etc. The company’s export business has been growing steadily and accounts for almost 45 per cent of Indoco’s total revenues. The company has alliances with major generic companies in the US and have a large pipeline of products under approval in the niche ophthal segment. At Indoco, the regulated market product pipeline is selected very carefully and the company has started preparing for product registrations in the injectable category for the next growth wave. STRATEGY FOR SUCCESS
Indoco aspires to increase the share of its international business to over 50 per cent of its total sales. The business is spread across a number of countries, thus de-risking the company from exchange fluctuations or political risk from a particular country/region. Going forward, the
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company's international business is expected to grow speedily as ANDAs would be commercialised at regular intervals. EU approval of newly acquired solid dosages
competitors in the international business. The company has nine products in the US market and 42 ANDAs are pending for approval. With a target of filing
EXPORTS PORTFOLIO Major export destinations: The UK, US, Germany, South Africa, Canada, Kenya, Myanmar, Ireland, Tanzania, Ukraine, Uganda, Sri Lanka etc. Key export products: Paracetamol, Allopurinol, Latanoprost Dorzo-Timo Maleate, Metformin, Ciprofloxacin, Cetirizine Metex-Xr, Dorzolamide, Indo-Metformin
Exports revenue in 2016-17: ` 41439 lakhs manufacturing facility at Baddi and expected marketing authorisations (MAs), against EU CTD dossiers filed, will also pave the way for higher growth in the European market. Products developed at their R&D centre are applied for registration not only in US, but also in Europe, South Africa, New Zealand, Australia, etc. Indoco is also consolidating its position in the emerging markets through active brand promotion in Africa, Asia and a few Latin American countries. A robust pipeline in multiple dosage forms, including niche ophthalmic products, is expected to enable the company to have an upper edge over its
10 ANDAs every year in niche segments, including injectables, the company intends to register an impressive growth in the US market, year after year. As a next wave of growth, the company has commenced filing of ANDAs for injectables, a few slow releases and First to File (FTFs) solid Dosages. Alliances on profit sharing basis with big generic players in US, gives the company a secure market share. Expertise in R&D backward integration in API in select molecules, own CRO set-up, excellence in finished dosages manufacturing and a strong customer base is expected to drive consistent growth in the company’s international business across all continents.
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AN ALL ROUNDER
Aditi Kare Panandikar is the MD at Indoco Remedies, a fully integrated, research-oriented Indian pharma company with presence in 55 countries. Indoco, a $165 million company, employs over 6000 people, including over 300 skilled scientists. Kare Panandikar is a third generation entrepreneur with sharp business acumen and techno-commercial skills. She is a graduate in Pharmacy, holds a Masters Degree in Pharmaceutical Administration from the Ohio State University, US. Patent law and practices is another area in which she has pursued an in-depth study. Prior to her elevation as the MD, she has handled various functions like, Domestic Marketing - Formulations, API Business, HR, Technical (R&D & QA) and Business Development (International) at Indoco. Kare Panandikar received the ‘Leader of the Year’ award at the at the UBM India Pharma Awards in 2016, ‘Business Woman Of The Year’ award at the Business Goa Awards for Corporate Excellence 2016 and ‘Jack L. Beal Post-baccalaureate Alumni’ award from the Ohio State University for her outstanding contribution to the pharma industry in May 201.5.
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Aditi Kare Panandikar Managing Director Indoco Remedies
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PANACEA BIOTEC Panacea Biotec exports to over 60 countries all over the world including regulated, semi-regulated and developing countries
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anacea Biotec is a leading biotechnology company involved in research and development, production and marketing of pharma products, vaccines and biopharma products. The company employs an experienced, seasoned and dedicated workforce of 2,500 highly-trained and skilled individuals who oversee, manage and facilitate its daily operations. It has four R&D centres employing over 90 scientists and invest close to 7 per cent of its revenue in R&D. Presently, the
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company generates an annual revenue of over $101.5 million (` 672.46 crore). EXPANDING EXPORTS
The erstwhile parent company of Panacea Biotec, Radicura Pharma and Panacea Drugs, set up in 1984, started exporting drugs and vaccines in the year
1992 to Afghanistan, Sri Lanka and Zaire. After the amalgamation of two companies and formation of Panacea Biotec in the year 1995, the company started expanding exports market consistently from the year 1995 when it was exporting to about seven countries including Russia, Ukraine,
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The company’s strategy is to increase its focus on developing, registering and marketing product portfolios catering to chronic therapies in private markets in overseas countries
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Germany and Kenya. Panacea started exporting vaccines to UNICEF, GAVI and many national governments of various African and Asian countries from 1995. Today, Panacea Biotec exports to over 60 countries all over the world including regulated, semi-regulated and developing countries. Major products/brands exported are pentavalent vaccines, oral polio vaccines and drugs like Nimulids, Tacrolimus, Cyclosporin, Mycophenolate, Glizid, Sitcom, PacliALL, Livoluk etc. STRATEGY FOR SUCCESS
The company’s current strategy is to reduce its dependence on tender business and increasing its focus on developing, registering and marketing product portfolios catering to
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chronic therapies in private markets in overseas countries. The company has 25 products under various stages of development to be registered in over 26 countries and plans to file the registration dossiers for the same in the next 12-15 months. Panacea Biotec has signed two strategic alliances with Canada's largest pharma company, Apotex Inc, marketing and distribution of its drug delivery-based generic
products in the US, Canada, Australia and New Zealand markets and with US- based Rising Pharmaceuticals Inc. The company has registered its vaccines in around 16 countries with further registrations in around nine countries expected in the near future. The company targets to enter emerging markets with sizeable birth cohort (3-5 million) to expand business.
EXPORTS PORTFOLIO Major export destinations: Africa, Asia, Europe, the US, CIS Key export products: Nimulids, Tacrolimus, Cyclosporin, Mycophenolate, Glizid, Sitcom, PacliALL, Livoluk Exports revenue in 2016-17: `183 crores
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A STRATEGIC LEADER
Dr Rajesh Jain is the Joint MD for Panacea Biotec. He is responsible for innovation and business development and is a member of prestigious organisations and committees such as Vaccines and Immunosera for Human Use of Indian Pharmacopeia (IP) in the year 2017, Research Council of CSIR – Central Drug Research Institute (CSIR-CDRI), Lucknow for the year 2017-18, Startup India: Board Member for Innovation and Incubation Foundation (DIIF) - Delhi Pharmaceuticals Sciences and Research University (DPSRU) for the year 2017. Dr Jain’s commitment and actions towards making affordable vaccines for mass population across the globe were well appreciated and valued by The Global Alliance for Vaccines and Immunisations (GAVI) and Bill & Melinda Gates Foundation at pledge conference in London on June 2011 and again in GAVI Replenishment Pledging Conference in January, 2015.As Chairman of CII National Committee on Biotechnology for two consecutive years (2011-12 & 2012-13), Dr Rajesh Jain has been driving numerous initiatives for providing better business and regulated environment for nurturing biotechnology industry in India.
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Dr Rajesh Jain Joint MD, Panacea Biotec
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FOURRTS A company with over 40 years' standing, it has presence in both, domestic and export markets and is ranked amongst top 50 fast growing Indian companies
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ourrts is one of the leading pharma formulation manufacturers and exporters from India with a standing of 40 years. Fourrts has presence in both, domestic and export markets. Ranked amongst top 50 fast growing Indian companies, it is credited with many first launches of pharma and nutraceutical formulations in India, with presence in gastro enterology, respiratory, diabetic and urology/infertility segments. They are now looking for ethical and liked minded associates for both in-licensing and out-licensing activity.
EXPANDING EXPORTS
In 1993-94, Fourrts ventured into exports with Africa. Now, it has presence in over 37 countries and intends to expand brand marketing in ROW markets. In 2001-2002, with increased focus on exports, a full-fledged team was setup by recruiting experienced personnel for business development, regulatory and commercial activity. Dossiers were filed in various countries and that year registered a turnover of ` 5.75 crores from six countries, including presence in Latin America.
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In 2005-06, it achieved a turnover of ` 17.20 crores with presence in approximately 15 countries. In 2010-11, the company reached ` 41.32 crores with presence in around 20 countries. In 2011-12, Fourrts achieved a milestone with its state-ofthe-art MHRA approved facility. It acquired marketing appovals for seven molecules from UK and was ready to set foot in SRA markets to be
WORLD-CLASS FACILITIES
Fourrts’ Plant I is a WHO-GMP approved, ISO 9001:2015 certified facility for tablets, capsules, liquids orals, creams, ointments and medicated toothpaste. Its R&D centre is approved by DST, Government of India. This unit is audited and approved by Ministry of Health of more than 20 ROW countries. The company also supplies medicated toothpaste to Canada.
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The company has plans to add new countries from ROW markets in the next three years with increased brand promotion in each existing market. In the next five years, Fourrts plans to attain a turnover of more than ` 400 crores in exports
counted amongst big league players. In the regulated markets, currently it exports generics to the UK and is opening up exports to Europe, Australia, Canada and the US. In 2015-16, Fourrts achieved an export turnover of ` 101.60 crores from ROW and regulated markets, thereby crossing the first landmark of `100 crores. The company claims that ‘Delighted customers across the globe are the soul strength of Fourrts’.
Plant II is a UK MHRA approved, ISO 9001:2015 certified facility for tablets and capsules. Fourrts is associated with several Indian and multinationals for formulation development and manufacturing from the MHRA facility. It boasts of a state-of-the-art FR&D setup with annual production capacities of tablets at 32 billion per year and capsules at 350 million per year. STRATEGY FOR SUCCESS
The company has plans to add
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new countries from ROW markets in the next three years with increased brand promotion in each existing market. It is in the process of implementing a strategy for deeper penetration in various regions in the countries with existing presence. The company also intends to focus on getting into Latin American markets through SRA approved facility as contract manufacturer and marketing our own brands. Another strategy is entering the PIC’s countries through products manufactured in the MHRA approved facility by developing 10 formulations during the
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next three years. Participate in global tenders from UNICEF and World Bank. Work is in progress on triggering the US FDA audit for Plant II initially as contract
manufacturer and after two years, filing own ANDAs. In the next five years, Fourrts plans to attain a turnover of more than ` 400 crores in exports.
EXPORTS PORTFOLIO Key export products – Fourrts offers products in Gastrointestinal, Respiratory, Cardiovascular, Anti-diabetic, Anti-inflammatory, Anti-bacterial, Anti-depressant & Nutraceuticals. Exports revenue in 2016-17: `106.43 crores Major export destinations: UK and Australia for Regulated Markets and Africa, South East Asia, Latin America, etc in ROW Markets
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A PASSIONATE LEADER
SV Veerramani is the CMD of Fourrts. He began his career with Dey’s Medicals, Kolkata, as a medical representative and worked for seven years before starting his own venture. He is a first generation entrepreneur hailing from a family of highly placed government officials.He started Fourts, along with three other directors, in the year 1977. His positive attitude gave him the strength to tide over those turbulent years as an young entrepreneur. Finally, during the year 1991, he became the CMD after the departure of other directors and the company name got changed as Fourrts. Radha Veerramani joined him in 1991 and played an anchoring role in the organisation by taking care of finance, production and materials. This enabled Veerramani to concentrate on his passion i.e. marketing and ensure growth. From 1991 there has been no looking back for Fourrts. It has grown year after year by introducing unique and innovative brands, some of which were launched for the first time in the Indian market. Veeramani has held various positions that became a way of life amongst which the biggest achievement was to be elected unanimously as the National President of IDMA for three consecutive years from 2014-2016.
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S V VEERRAMANI Chairman and MD, Fourrts
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RUSAN PHARMA With the company’s thrust on technology from the very beginning, Rusan had been committed since its inception in bringing forward niche and value added products for the global and Indian market
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usan Pharma is a fully integrated global pharma company started in 1994 by its current Chairman, Dr Navin Saxena. Rusan offers a one-stopsolution for treating various forms of addictions such as drugs, alcohol and tobacco. Since 1994, Rusan has been at the fore-front of making Opioid Substitution Treatment (OST) an acceptable form of treatment in India. The company is one of the reputed and largest suppliers of life saving drugs (de-addiction, pain management and anti-TB drugs) to various organisations/ministries like NACO, UNODC, UNOPS, Global Fund, Ministry of Health, Ministry of Justice of countries like India, Europe, UK, Russia, CIS, South Africa, Mauritius, Nepal, Myanmar. Rusan markets its products mainly in the UK, Europe, Russia, Ukraine, Uzbekistan, Kazakhstan, South Africa, South East Asia, and soon intends to expand into the US and Canada. Apart from a head office in Mumbai, India, internationally, they have offices in Moscow, Kiev, Tashkent, India, and Sharjah. Rusan’s manufacturing facilities include one API manufacturing facility and three finished dosage facilities in India and one API manufacturing facility and one finished dosage facility in Europe.
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EXPANDING EXPORTS
Rusan Pharma started with a R&D and formulation development centre (Approved by Department of Science & Technology, Government of India) in Mumbai. With the company’s thrust on technology from the very beginning, Rusan had been committed since its inception in bringing forward niche and value added products for the global and Indian market. To take this dream forward, in the year 2000 the company acquired a formulation unit from Novarits India, located at Kandla Special Economic Zone, Gujarat
to meet the requirements of WHO GMP and many others. Further to get a competitive edge, Rusan extended its activities by establishing an API manufacturing facility at Ankleshwar, Gujarat. It has received state GMP Approval and EDQM Approval which helped enable backward integration and complete control over quality. With these facilities in place Rusan was able to expand its exports business and reach their products to many countries globally. In the year 2008, another formulation unit to explore the domestic and international
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Rusan Pharma has taken over the social challenge to treat addiction in all forms and have developed all the required medications in advanced drug delivery systems leading to high percentage of success rate
for manufacturing its range of products covering major therapeutic groups and life saving drugs in the form of injectables, capsules, coated and uncoated tablets etc. This facility is spread over an area of 300,000 sq.ft. with constructed area being 100,000 sq. ft. and 50 per cent of the area being green area. The manufacturing facilities for tablets, injectables and beta lactum are each housed in separate and independent buildings and have been upgraded
market was established in Selaqui Dehradun. It has been designed to manufacture oral solid dosage (OSD) forms-tablets and hard gelatin capsules, oral liquids, parenteral preparation (ampoules, vials, pre-filled syringes and lyophilised products) and transdermal patches. STRATEGY FOR SUCCESS
Addiction from drugs, alcohol or tobacco is a rising epidemic of our decade which also lies at the base of various diseases such as HIV,
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Hepatitis-C, various cancers ,depression leading to a serious economic burden for India and globally. Other factors such as family violence, theft and crime are a major issue for the health of our society. Rusan Pharma has taken over the social challenge to treat addiction in all forms and have developed all the required medications in advanced drug delivery systems leading to high percentage of success rate. Since most of the medications are opioid derivatives, Rusan Pharma has painstakingly in the last 20 years developed patented technologies for the synthesis and the high technology formulations such as the transdermal patches/implants and the nasal sprays. The governments of various countries are now accepting addiction as a disease and thus being more proactive in bringing treatment to the forefront and working on preventive models which will also help to ease the heath economic burden. Rusan is a front-runner in this sphere and is approached by various MoH across the African, South-East Asia, Latin American continent to name a few. This will give a boost to exports as the market is expected to reach $27.91 billion by 2025, expanding at a CAGR of 8.7 per cent from 2017 to 2025. Rusan has also been a pioneer
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in pain management and palliative care. All the opioids synthesised by Rusan are in the most advanced delivery systems such as the transdermal patches. The transdermal market is set to cross more than $40 billion by 2020. Rusan is ready with most of the medications through the transdermal route and the highest capacity in India. On a whole, the global pain management therapeutics market is expected to
expand at a 3.7 per cent CAGR over the period between 2016 and 2024. At this pace, the market is expected to rise from a valuation of $60.2 billion in 2015 to $83.0 billion by 2024. Rusan expects to achieve high growth and contribute towards working in its niche area of addiction and pain management thus fulfilling its corporate social responsibility of building a healthy society.
EXPORTS PORTFOLIO Major export destinations: UK, Europe, Russia, Ukraine, Uzbekistan, Kazakhstan, South Africa, South East Asia, and soon intends to expand into the US and Canada Key export products: Methadone Oral Syrup, Buprenophine + Naloxone, Acetaminophen, Pheniramine Maleate, Phenylephrine HCl Granules, MDR-TB – Para SK IV, Nalbuphine Injections, Metmoformin Exports turnover in 2016-17: `79 crores
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HELMING PROGRESS
Dr Navin Saxena is the Founder & Chairman of Rusan Pharma. He earned his Post Doctorate in ‘Synthetic Organic Chemistry’ from the Moscow Friendship University, Russia. Dr Saxena started his career with Unichem Laboratories India in 1981 as a Research Officer and completed his tenure as Vice President & Head of Research, Unichem. At Unichem Laboratories, Dr Saxena successfully developed the bulk drug technologies of various latest life saving drugs for the first time India. After his tenure with Unichem, Dr Saxena founded Rusan Pharma in 1994. In 1996, he established Research Centre for Rusan in Mumbai. Continued his expansion for Rusan by setting up the API manufacturing facility in Ankleshwar in 1999. To cater to the growing export business, in 2000, he quickly set up the formulation manufacturing unit, in Kandla SEZ, and in 2009 he built a formulation-manufacturing unit in Dehradun, Uttarakhand. Dr Navin Saxena is a visionary and through his commitment towards developing treatment for difficult diseases such as addiction and pain management with high technology delivery formats. Rusan is taking the same vision forward to treat all those in need and help bring them to a new lease of life.
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Dr Navin Saxena Founder & Chairman Rusan Pharma
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SHILPA MEDICARE With diverse, regulatory-recognised manufacturing set-ups and excellent scientific manpower, Shilpa has been on a consistent growth path
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hilpa Medicare started its operations as an active pharmaceutical ingredients (API) manufacturer in 1987 at Raichur, Karnataka, India. Later, it became a public limited company and got listed at Bombay Stock Exchange in 1995 and the National Stock Exchange (NSE) in 2009. The company manufactures high-quality APIs, intermediates, formulations, new drug delivery systems, peptides/biotech products and speciality chemicals etc., utilising sophisticated technology to comply with international standards/ specifications. Shilpa Medicare’s facilities have received key regulatory approvals for its facilities as well as for its products from the US FDA, EDQM, TGA, PMDA and KFDA etc. With diverse, regulatory-recognised manufacturing set-ups and excellent scientific manpower, Shilpa has been on a consistent growth path. Its formulation research centre is concentrated on developing generic equivalents to reference listed drugs for global markets like the US, Europe and ROW for injectable and oral formulations used for treatment of cancer and other indications like multiple
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sclerosis, liver diseases, HIV etc. The research centre also concentrates on the development of new formulations, leading to reduced costing and enhanced stability of the drug products. The R&D centre also works on converting the existing lyophilised products to ready-
Greece, Cyprus, Italy, the UK etc., the company also caters to South American countries like Mexico, Brazil, and Columbia etc.; African countries like Kenya, Nigeria and West Indies etc. and Asian Countries like Singapore, Taiwan, China, Malaysia, Thailand, etc. Their formulation site has
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Shilpa Medicare has been manufacturing for both exports and domestic markets since 1992. Its skilled team and certified manufacturing capabilities have proved to be a significant differentiator among discerning buyers in the highly regulated markets of US and Europe
to-use liquid and on development of ready-to-fill powders for injectable administrations.
been approved by US FDA, WHO GMP, Cofepris-Mexico, EUGMP and Anvisa-Brazil. STRATEGY FOR SUCCESS
EXPANDING EXPORTS
Shilpa Medicare has been manufacturing for both exports and domestic markets since 1992. Its skilled team and certified manufacturing capabilities have proved to be a significant differentiator among discerning buyers in the highly regulated markets of the US and Europe. Besides exporting to the US, Canada, Australia, Japan and European countries viz.,Germany, Switzerland, Netherlands, Belgium, Spain,
Shilpa Medicare’s future business strategy includes expansion of the formulation business in new portfolios like ODF, transdermal patches, biologics etc. It is focussed on the development of innovative formulations using nano and micro technology. It also has plans to undertake contract manufacturing activities for APIs and formulations for local and international clients. It intends to continue its focus on the entry into regulated and
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ROW market through strong marketing associations. There are plans to expand to new geographical territories – Brazil, Canada, China and Singapore etc, alongwith continuous and strong interaction between countries for marketing, new launch management, pricing and business support.
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EXPORTS PORTFOLIO Major export destinations: The EU, Japan, the US and Asian countries Key export products: Oncology and non-oncology APIs and formulations Exports revenue in 2016-17: `46,857 lakhs
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A MULTI-FACETED LEADER
Vishnukant Bhutada has been the Founder & MD, Shilpa Medicare Group since its inception. He has vast and diverse experience of APIs and formulations business and presently leads the core business and functional teams at Shilpa Medicare Group of Companies as a key decision maker. His untiring efforts have led the company to a leadership position in the Indian pharma domain. He has several awards and accolades to his credit including the Best Entrepreneur Award by Late Dr Shankar Dayal Sharma President of India in 1995. He has also received various state honours such as Best Entrepreneur from Karnataka State Government in 1996; Excellence in Exports from Vishweshwarayya Industrial Trade Centre, Bangalore from 1996-2017; and Export Excellence Award by FKCCI, Bangalore from 1996-2017. Recently, his efforts for environment sustainability enabled the company to win the Best National Energy Conservation Award in Drugs & Pharmaceutical Sector for 2012 from the erstwhile President of India, Dr Pranab Mukherjee. Bhutada also received Pharmexcil’s Patent Award in recognition of commendable contribution in pharma patents.
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Vishnukant Bhutada Founder & MD, Shilpa Medicare Group
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ZIM LABORATORIES The company, known for its innovative products manufactured using innovative process technologies, derives 70 per cent of its total business through its export markets
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Z
im Laboratories was founded in 1989, with its first manufacturing facility set-up in the industrial area of Nagpur city in Central India. Even during its days as a small scale pharma company, the intention was to provide new drug delivery systems, which over time became the company’s true strength. Today, ZIM is known for its innovative products manufactured using innovative process technologies. The fact that these products are manufactured using customised processes make them affordable. Presently, ZIM can produce any aspect of drug delivery solutions in oral solid forms encompassing tablets, pellets, directly compressible granules, taste masked powders/granules, dry suspensions, fast dissolving thin films, etc. The company believes that innovation and implementation of technology is the only way forward as a perquisite to being able to provide pharma solutions. This led to the development of their own proprietary technologies of pellet formulations, tastemasked products and the recent, orally disintegrating strips (ODS), at their R&D centre, which is approved by the Department of Scientific and Industrial Research (DSIR),
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Government of India. The company has also filed many patents for protecting and safeguarding their research. With the thrust on innovation and high-throughput, technology-based niche products, characterised by technical complexity and market differentiation, ZIM is now placed among an exclusive list of technology-based companies, with an expertise in solubility enhancement, tastemasking, physical transformation and modified release. Their manufacturing unit is
different ROW and emerging markets worldwide. There are plans to include many more in the near future. EXPANDING EXPORTS
Zim started out as a domestic manufacturer, providing institutional supplies and catering to Indian domestic market. In the year 2000, with a conscious effort to expand its market share as well as markets, Zim Laboratories ventured into the export market. Initiating the business through Middle East and North Africa markets, it steadily moved into CIS and
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ZIM has been able to expand its presence in high growth markets, both functionally as well as geographically, with presence in almost 40 countries across different ROW and emerging markets worldwide
an EU-GMP, WHO-GMP and ISO 9001:2008 accredited facility with dedicated blocks for orally disintegrating strips (ODS), cephalosporin and general manufacturing. Based on these facilities and an efficient quality management system, ZIM has been able to expand its presence in high growth markets, both functionally as well as geographically, with presence in almost 40 countries across
South East Asian countries. Zim’s earliest markets include countries from SAARC and Middle East region. After consolidating its presence in the aforementioned regions, the company then started working in Latin America, African continent, CIS and South East Asia as well, and now have been developing its product range for entry in the regulated markets. Company sources reveal that the initial struggle to
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establishing Zim as a worthy candidate to provide quality products at an affordable price, and convincing the customers was a very challenging, at the same time, a great learning experience for the team. Language and technology barriers were overcome by discussions and meetings with the customers. Today, the company caters to the customised needs of their overseas clients and manufactures products of high quality that meet the standards set by countries’ Ministry of Health, as is evident by Zim’s certifications. Currently, with exports to almost 40 countries, Zim’s product list has a vast range covering most of the therapeutic areas like infectious diseases, central nervous system, cardiovascular system, gastroenterology, urology, gynaecology, and endocrinology, to name a few. Approximately, 70 per cent of Zim’s total business comes through its export markets. The sheer numbers in terms of volume of business that is generated through these exports is an indication of the success of Zim as a pharma exporter with a reputation to bank on as a reliable business partner. This image of Zim in foreign countries and among foreign partners has
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in course of time helped it gain valuable customer base in the existing markets and newly developing markets as well. During the course of this journey, Zim has had many achievements to its credit. As a member of Pharmaceuticals Export Promotion Council of India, it is enlisted in the category of large scale manufacturers. Zim also has a
complex generics using innovative process technologies to ensure patient convenience and adherence. Moreover, the company also informs that it utilises only non-infringing and proprietary process technologies. The company’s manufacturing plants are EUGMP approved and products for regulated market are under development. So, in this way
EXPORTS PORTFOLIO Major export destinations: SAARC Countries, MENA region, Africa, Latin America, South East Asia, Russia & CIS Key export products: Pellets: Release modified multiparticulates, Directly Compressible Granules, Taste Masked Granules and Powders, Dry Syrups for re-constitution, Oral Thin Films Exports revenue in 2016-17: `235 million/$ 36 million 3-Star Export House status from the Government of India, and is currently the largest pharma exporter by air across Central India. STRATEGY FOR SUCCESS
With ever increasing competition, being ahead of your competitors is the need of the hour. The company’s strategy is to develop more number of conventionalproducts into
there will be addition of regulated market to the existing territories. Providing complex generics as per client and market needs, and application of technologies developed, Zimis now geared to confidently expand its footprint to newer countries and markets. Zim is also prepared to increase its share in the Indian pharma export market, both in terms of sales volumes and differentiated quality products.
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AN ABLE LEADER
Zim Laboratories’ current position as a successful pharma company, offering differentiated and niche products worldwide, is largely due to the sincere efforts of Dr Anwar S Daud, who serves as the MD and Chairman of the company. He started off his career at IPCA Laboratories after completion of his postgraduation. However, his wish to be a part of an initiative that would help in the overall development of his native place and its people made him return to Nagpur and get involved with Zim Laboratories. An avid reader and ardent learner, he is always in touch with the latest developments in the fields of pharma research and technology. He has about 20 patents and several research papers to his credit. He has served on the Board of Studies for Nagpur and Amravati Universities. He has also been nominated as an industry member of All India Board of Pharmaceutical Education, constituted by AICTE and as a member of the Ayurvedic Drugs Standardization Committee (FDA), Maharashtra. He has been felicitated time and again, by various organisations for his contributions towards industry and society.
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Dr Anwar S Daud MD Zim Laboratories
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ALEMBIC PHARMACEUTICALS Alembic Pharma manufactures and markets generic pharma products across the globe and is one of the leading players in the industry to have invested about 14 per cent of its turnover in R&D
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lembic Group is an Indian conglomerate with significant presence in various industries such as pharma, glass, chemicals, real estate, engineering, education and healthcare. Alembic Pharmaceuticals, the flagship company of the Alembic Group, is one of the leading pharma companies in India.Its legacy dates back to over 110 years. The journey began on July 31, 1907 as the knowledge of chemistry met business acumen and was guided by able leadership. Alembic is the brainchild of Prof TK Gajjar – the first renowned chemist in Western India, Prof Kotibhaskar – a Gold Medalist in Technological Chemistry, and Rajmitra BD Amin. The organisation was conceived under the guidance and support of his Highness Maharaja Sayajirao Gaekwad. Today, it is a publicly listed entity that manufactures and markets generic pharma products across the globe and has grown by leaps and bounds over the last century. The company has also established a state-of-the-art research facility – Alembic Research Centre (ARC)including formulation research, and 150-bed bioequivalence facility at Vadodara, Gujarat.
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Additionally, Alembic has recently invested in ultramodern R&D center at Hyderabad. Alembic is one of the leading players in the industry to have invested about 14 per cent of its turnover in R&D. EXPANDING EXPORTS
Alembic has transformed itself into a vertically integrated, full fledged pharma giant with major focus on exports. It has presence across 80 countries worldwide and front end presence in the US. In FY 201617, export contributed 58 per
markets like Europe, Australia and Canada and that is ever expanding. The company cleared USFDA and EU audits for its API, formulations and R&D units, thereby showcasing the institutionalisation of globally-best systems and processes. >90 per cent of the R&D resources are allocated towards developing products for the US markets which, in turn, can be leveraged for strengthening its presence in other regulated markets. The company has >43 ANDAs pending approval, of
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Alembic has transformed itself into a vertically integrated, full fledged pharma giant with major focus on exports. It has presence across 80 countries worldwide and front end presence in the US
cent in its total sales turnover of $467 million. More importantly, export has been growing at CAGR 28.6 per cent for last five years vis-à-vis organisation’s growth of CAGR 15.6 per cent. Alembic has established a visible presence in the world’s largest and highly competitive pharma market i.e. the US, thereby gaining respect in the global pharma space. Other than its US operations, the company enjoys a meaningful presence in other regulated
which 40 per cent comprise complex and challenging developments as well as >36 filings in other regulated markets at various stages of approval. With intent to foray into high entry barrier segments like oncology, dermatology and ophthalmic, Alembic has already invested in creation of infrastructure. STRATEGY FOR SUCCESS
As a growth strategy, the company has aggressively
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started investing in the international generics market with successful ANDA and DMF filings. Alembic Pharma has also filings across Canada, Europe, Australia, South Africa and Brazil. The company caters to the rest of the world markets through branded formulation sales. The company aims to explore opportunities in the therapeutic areas such as dermatology, oncology, and injectable formulations. Alembic Pharma has also co-promoted a company focused on discovery and
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development of innovative, small molecule drugs that target signal transduction networks and ion channels for
the treatment of cancer, inflammation, autoimmune diseases and metabolic disorders.
EXPORTS PORTFOLIO Major export destinations: US, Canada, Europe, Australia, South Africa and Brazil
Key export products: Psychiatry, Cardio vascular, Antibiotics, Pain Management, Neurology Role of exports in 2016-17 : 58 per cent of total sales turnover of $467 million
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THE DYNAMIC DUO CHAIRMAN & CEO
Chirayu Amin, the Chairman and CEO of the Alembic group, has played a pivotal role in the growth of the organisation. He has successfully managed the critical process of business reorientation and restructured the organiaation to realign the company towards its new objectives. Being an MBA from the US, Chirayu Amin has well adapted to the changing needs of modern day business while keeping intact the legacy of more than 100 years. Along with being the chairman of all Alembic group businesses, he also holds the trusteeship in the hospital and schools that fall under the aegis of Alembic Group. MANAGING DIRECTOR
Pranav Amin is the MD of Alembic Pharma and heads the international business unit of the organisation. He joined the organisation in 2007 as a Director and was elevated to the position of Joint MD in 2015. In April 2016, he took charge as a MD. A graduate in Economics/Industrial Management from the Carnegie Mellon University in Pittsburgh, USA and MBA in International Management from Thunderbird, Arizona State, USA, he is a great people leader and leads his enterprise through involvement, empowerment, and autonomy.
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Pranav Amin MD, Alembic Pharma
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MARKSANS PHARMA After establishing its presence in developed markets, Marksans is now expanding its focus towards emerging markets where it has received over 350+ approved products and 200+ products pending approvals
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arksans Pharma, headquartered at Mumbai (India) is a global pharma company. It is actively engaged in R&D and offer CRAMS to global pharma companies. Its key focus areas lie in the OTC and prescription drugs that have wide-ranging applications across fields like oncology, gastroenterology, antidiabetic, antibiotics, cardiovascular, pain management, gynaecology, among others. It has established world-class manufacturing facilities by leveraging state-of-the-art technology, incorporating best practices and adhering to stringent regulatory compliances. Its plants are approved by prestigious US FDA, UK MHRA, Australian TGA and other foreign health authorities. Its R&D capabilities include dossier development, chemical synthesis, process optimisation, formulation development, analytical development and conducting stability studies. It has a team of over 50 experienced scientists specialising in formulation development and analytical development. The company possesses endto-end capabilities – from lab scale development to pilot scale up and from commercialising the
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product for large scale manufacturing to marketing globally. The company has achieved global recognition within a very short span of time and has major global expansion plans for the near future. EXPANDING EXPORTS
The company has a special focus towards exports markets like US, Canada, Europe, and Australia. Through ongoing research and product development, it has been able to grow from strength-tostrength in these markets. After establishing its presence in these
from esteemed organisations such as US FDA, UK MHRA, Australian TGA. The company also has a WHO GMP certificate. This factory has the largest soft gel manufacturing facility in India. This is a 100 per cent export-oriented unit (EOU). To strengthen its global efforts, a full-fledged R&D centre has been set up along with the manufacturing facility at Verna, Goa. As far as inorganic growth is concerned, Marksans intends to gain a foothold in the Australasia region. It has acquired Nova Pharmaceuticals Australasia Pty
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The company has a special focus towards exports markets like US, Canada, Europe, and Australia.Through ongoing research and product development, it has been able to grow from strength-to-strength in these markets.
markets, Marksans is now expanding its focus towards emerging markets where it has received over 350+ approved products and 200+ products pending approvals. Its formulation manufacturing plant at Verna, Goa, has state-of-the-art facilities and is specially designed to meet the global statutory requirements. This plant is US FDA approved and has approvals
Ltd., in Europe, and Bell, Sons & Co (Druggists) Ltd. a UK MHRA approved formulation manufacturing and marketing company exporting liquid, ointment and powder to 50 countries globally. Further, in order to build capabilities across the entire value chain, it has acquired Relonchem Ltd., which markets and distributes high-end prescription products in UK. These acquisitions have given
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an opportunity to leverage the low cost manufacturing base in India and further enhance the profitability by supplying to global markets. STRATEGY FOR SUCCESS
Marksans aspires to become one of the most respected, profitable and integrated global pharma company that delivers international standards on all counts. In order to achieve this objective, it also has a special focus towards anticipating trends in the emerging markets, as well as reviewing the demands of the developed markets. Along with these focus markets, it is also trying to tap the Russian and CIS markets. In the past few years, the company has achieved remarkable growth across markets. Starting with exports to emerging markets, the company has successfully penetrated into the regulated markets. With the approval from the prestigious UK MHRA and US FDA, Marksans has actively started exporting formulation to UK and US. It has tied up with renowned players in these markets to aid distribution of OTC as well as prescription products. Marksans has initiated dossier filling in the Russian and CIS markets. They are also
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registering its own dossiers, developing products going off patent and applying for registration of drugs that are shortly going off patent in the global markets. Through contract manufacturing and active
product registrations, Marksans is expanding its business across the rest of the European markets. They are focused towards formulation development and have a strong back up in terms of R&D and aggressive marketing plans.
EXPORTS PORTFOLIO Major export destinations: US, Canada, Europe, and Australia, Middle East, South East Asia, Russia-CIS Key export products: Products in analgesics, expectorants, anti-diabetic, cardiovascular, central nervous system, gastrointestinal and oncologic drugs, antibiotics and antiallergic medications.
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A MULTI-FACETED LEADER
Dr Vinay Gopal Nayak is the Executive Director of Marksans Pharma. He is a pharma professional with a technical background. He is specialised in the areas of manufacturing, quality, R&D, compliance and regulatory affairs both for API and finished dosage form manufacturing. In a career span of 30 years, he has provided leadership to renowned organisations to become global leaders in their specialised segments. Dr Nayak has successfully handled USFDA and other international regulatory inspections with good leadership and sound technical knowledge. In the past 10 years, he has worked in senior positions at Watson, Alembic and Emcure. His strength/expertise involves selecting good teams, grooming them and meeting organisational expectations all these years. The other area of expertise has been useful is to outsource key products in situations for capacity release in existing plants to make space for new approved products. He has also handled expansion projects involving designing GMP plants for finished dosage form as well as API. Dr Nayak is a member of Indian Pharmacopoeia, Examiner of Mumbai University for Masters and Ph.D students. He is a winner of many awards and recognitions.
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DR VINAY GOPAL NAYAK Executive Director, Marksans
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BLISS GVS PHARMA In three decades, Bliss GVS standalone has emerged as a ` 400-crore niche player in suppositories and pessaries
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liss GVS Pharma was incorporated on December 11, 1984 as a public limited company. It is a fast growing company with a proven track record for developing, manufacturing and marketing high quality pharma formulations at affordable prices for the global and Indian markets. It is also a leading organisation in India for contract development and manufacturing for suppositories and pessaries for regulated markets. It is listed on India’s National Stock Exchange and Bombay Stock Exchange with more than three decades of industry expertise. In the year 1984, Bliss GVS was incorporated as Bliss Chemicals and Pharmaceuticals India, driven by four stakeholders. In 1986, the company launched its flagship product ‘Today’ – a vaginal contraceptive which became their blockbuster drug. Later in 2004, SN Kamath, the present-day Managing Director of the company, along with Gautam Ashra, Promoter, took over Bliss Chemicals. They both were convinced with the company’s potential and its products’ capabilities. In 2007, the company commissioned its
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manufacturing unit for tablets, dry syrups at Palghar in Maharashtra. This facility provided a boost to the company’s growth and in 2010 it opened a new state-of-theart manufacturing facility for suppositories and pessaries in the same premises at Palghar. After coming up with the facility, the company applied for EU-GMP approval and received it in 2011. Since its inception, Bliss GVS has always followed an organic approach for its growth. In 2012, the company acquired 70 per cent stake in
cater to the growing demand, the company has recently enhanced its production capacity and is now the world’s largest manufacturer of suppositories dosage form by volume. This manufacturing capability is complemented by a state-of- the-art R&D centre located in Mumbai focussing on developing suppositories and pessaries. Thus, the company sees a lot of potential in the suppositories segment and has been concentrating its efforts to leverage the growth opportunities. It feels that
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Bliss has a very strong focus on international markets, almost 95 per cent of the revenues come from exports. Africa dominates Bliss’s global footprint
Kremoint Pharma to strengthen its presence in the dermatology segment. In 2013, the company expanded its R&D Centre and received DSIR approval. In addition to this, the company launched the strategic marketing unit for front –end integration. Bliss GVS leads the suppository market in India by marketing its own brands and contract manufacturing for major pharma companies. To
suppositories can be used to deliver drugs in a wide range of therapeutic categories like anti-fungal, contraceptive, laxative, anti-haemorrhoidal, anti-spasmodic, antipyretic, analgesic, anti-malarial etc. It believes that there is a positive growth across all these categories in the Indian market and hence this drug delivery form can be a rewarding asset for Indian pharma companies with good marketing infrastructure.
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EXPANDING EXPORTS
Bliss has a very strong focus on international markets, almost 95 per cent of the revenues come from exports. Africa dominates Bliss’s global footprint. Currently, export to major African countries include Kenya, Nigeria, Francophone countries (like Ivory coast, Senegal, Mali etc.), Ghana, Uganda, Zambia, Burundi, Malawi etc. The company also has a substantial presence in other Asian countries. It informs that the demand for its products in each of the markets is growing at an increasing pace. Bliss is committed towards quality and consistent performance, which has given Bliss the confidence to explore new markets in Europe and the US. With new state-of-the-art EU GMP certified plant for suppositories ready, Bliss wants to establish itself in these demanding markets very soon. However, catering to customer in diverse countries has its fair share of challenges. Therefore, Bliss’ business development team is strategically located across the globe to provide specific and targeted market intelligence, which is then channeled through the product
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and regulatory teams as well as business associates to arrive at appropriate product portfolio. An experienced regulatory compliance team ensures that the company’s products meet stringent regulatory guidelines for each market. The company informs that it has already received multiple approvals for its
STRATEGY FOR SUCCESS
During the fiscal year 2016-17, the company’s consolidated revenue increased 44 per cent y-o-y basis to `825.32 crores and PBT was up by 20 per cent to `179.17 crores. It is aiming to achieve a growth of 10 per cent for the current fiscal year. The company’s pharma business delivered stable
EXPORTS PORTFOLIO Major export destinations: Kenya, Nigeria, France, Ghana, Malawi Key export products: Lonart, Funbact, Lofnac, P Alaxin, Cofantrine, healthcare services, Ointments etc Exports revenue in 2016-17: ` 69775.50 lakhs
formulations in suppositories and pessaries dosage form in regulated markets. Bliss’ product registration dossiers have been submitted in various regulated markets and it anticipates more registration in the next fiscal. It also has plans to have products which are a strategic fit in the regulated markets while in semi-regulated markets, hence the company has increased its pace of dossier submissions for registrations in South East Asia, CIS, Africa.
results despite a challenging macroeconomic environment in some of the markets. The plan has always been to identify, develop and market niche products and would like to continue with it. Now the company is planning to have strategic tie-ups with Indian and European companies for in-licensing and out-licensing of products. Thus, Bliss GVS has really come a long way and intends to scale greater heights in the coming years.
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A VISIONARY
SN Kamath, Promoter-cum-MD, Bliss GVS Pharma, is the force behind the success and growth of the company. A strong proponent of self-learning and learning by doing, these concepts have motivated him to ensure that Bliss GVS has a clear focus to develop indigenous products to reduce dependency on imports. Hailing from a village in Karnataka, he shifted his base to Mumbai during the early days of his career. Relying on his entrepreneurial skills and hunger to learn, he started his company and despite some bitter experiences, Kamath decided to remain rooted in the export business. His hard work ensured the success of his venture GVS Labs. He led the successful merger of GVS Labs and Bliss Chemicals and Pharmaceuticals, leading to the formation of the Bliss GVS Pharma. Under his aegis, for the past few years, Bliss GVS has been focussing on developing new suppositories formulations. It has a dedicated R&D department to develop alternatives to imported suppositories and newer formulations of well-known molecules, including some all new combination products. This, in turn, helps to make effective medicines available at a much lower cost to people in India, the Middle East and the not so affluent markets of Africa.
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SN Kamath MD Bliss GVS Pharma
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OPTEL GROUP OPTEL is a Canadian multinational, global leader for track and trace solutions practising responsible human capitalism
OPTEL Group’s corporate headquarters – Quebec City, Canada
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ecognised for its agility to design customercentric solutions, OPTEL’s growth has been driven by the mission of using its technologies to create a better world. Since its inception in 1989, its activities have focused on refining a portfolio of track and trace solutions developed to protect medical products across the global supply chain. The OPTEL GROUP is a Canadian company with the mission of using its expertise and innovative capacity to solve problems for the benefit of society as a whole. With over 27 years’ of recognised expertise in pharma, a multitude of
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OPTELaims to be a role model in corporate behaviors and lead the way to sustainable corporate responsibility through our involvement in civil society and through our humanoriented technologies. We ensure health,safety and environment protection while supporting children, education and justice around the world
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Louis Roy President OPTEL Group
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successful installations, an extensive worldwide team (1000+), four international locations, and eight out of 10 global generic pharma companies relying on the company for their serialization needs, OPTEL is the leading player in its field with an overall market share of 25.7 per cent. Their multidisciplinary team of first-rate professionals makes for an innovation-based engineering company that provides superior value and service to customers across the globe. The growth of the company is a testament to their success, service and financial stability. The company offers proven inspection and serialization know-how, start-to-finish project assistance, and personalised technical services— regardless of the customer’s location. With the experience gained through the integration of 2,000+ serialization projects around the
world, understanding the processes involved is second nature to the company. OPTEL IN INDIA
OPTEL became the first North American company to set up manufacturing base in Goa. They started their manufacturing operations in 2016. This facility was set up primarily to expand local operations and better serve customers. The company has been operating in India since 2012 and is already ranked No.1 in India in terms of value. From a corporate OPTEL GROUP AT A GLANCE
◗ Three decades of experience ◗ 3500 + installtions worldwide ◗ 45 global corporate accounts ◗ 4 locations ◆ Canada ◆ Ireland ◆ India ◆ Brazil ◗ 24/7 technical support
standpoint, this 42,000 sq. ft. facility serves as a manufacturing hub for the Asia Pacific region. “We chose to expand to India for two reasons: First, because it represents 20 per cent of the world’s generic drug market and, second, because the country has a large number of qualified engineers. Establishing a permanent site in India allows us to be closer to our customers while encouraging local production,” mentions Louis Roy, President, Optel Group. Currently, the company has almost 100 employees and this number is expected to increase to meet the demand. The Goa facility focuses on manufacturing and assembly operations, as well as provides demo and technical training to customers. In fact, they developed a different business model for the Indian market and put together a highly specialised customer service team, specifically for this market.
OPTEL Group Asia manufacturing facility - Goa, India
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SOCIALLY RESPONSIBLE
OPTEL Group is socially involved in India, helping local communities via SOS Children’s Villages, a Canadian charitable organisation. Every employee of OPTEL Group across the world works with OPTEL for a larger mission: To master the complex technologies and provide solutions to create a better world with responsible capitalism. As a Certified B Corporation and a champion leader of corporate social responsibility, OPTEL is expanding across various sectors by harnessing the power of global traceability to reduce waste and optimise processes at all levels of a product’s life, from cradle to grave. Sustainability through traceability is the way ahead for the company.
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We are committed to deliver Indian market specific,affordable ‘track and trace’solutions with global qualitystandards, empowering the pharma industryto meet global compliance.This enables the companies to protect their business,increase supplychain efficiency and fight against counterfeiting
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Shaunak J Dave CEO & MD, OPTEL Group, India & VP (Asia), OPTEL Group
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