Lupin Limited

Lupin Limited

Type	Public
Traded as	BSE: 500257 NSE: LUPIN
Industry	Pharmaceuticals
Founded	1968 [1]
Founder	Dr. Desh Bandhu Gupta[2]
Headquarters	Mumbai, Maharashtra[3], India
Key people	Kamal K Sharma, Vice Chairman;[4] Vinita Gupta, Chief Executive Officer, Lupin Limited;[5] Nilesh Gupta, Managing Director;[5] Shakti Chakraborty, Group President - India Region Formulations & CIS;[6] Vinod Dhawan, Group President AAMLA & Business Development;[7] Ramesh Swaminathan, Chief Financial Officer.[8] Dr Rajender Kamboj, President - Novel Drug Discovery & Development [9] Dr Cyrus Karkaria, President - Biotechnology [10] Naresh Gupta, President API & Global TB [11] Divakar Kaza, President- Human resources [12] Alpesh Dalal, Head - Investor Relations [13] Shamsher Gorawara, Head - Corporate Communications [14]
Products	Pharmaceuticals, branded and generic drugs, biotechnology, Advanced Drug Delivery Systems, New Chemical Entity Research, vaccines, Over-the-Counter drugs
Revenue	$1.83 billion USD (2013-2014) [15]
Profit	$304 million USD (2013-2014) [16]
Number of employees	15000+ [17]
Subsidiaries	Lupin Pharmaceuticals, Inc. Kyowa Pharmaceutical Industry Co. Ltd. I’rom Pharmaceutical Co. Ltd. Pharma Dynamics Multicare Pharmaceuticals Generic Health Pte. Ltd. Hormosan Pharma GmbH
Website	www.lupin.com

Lupin Limited is a transnational pharmaceutical company based in Mumbai. It is the seventh-largest ^[18] company by market capitalization;^[19] and the 10th-largest generic pharmaceutical company by revenue ^[20] globally.^[21] Lupin is the fifth-largest generic pharmaceutical company in the US by prescription-led market share ^[22] and 3rd largest Indian pharma company by revenue.^[23] It has the distinction of being the fastest growing generic pharmaceutical player in the two largest pharmaceutical markets of the world – the US^[24] and Japan;^[25] and is the 4th largest and the fastest growing generic pharmaceutical player in South Africa.^[26]

History and evolution

Lupin was founded in 1968 by Dr. Desh Bandhu Gupta,^[27] then an Associate Professor at BITS-Pilani, Rajasthan. Named after the Lupin flower because of its inherent qualities and what it personifies and stands for, the company was created with a vision to fight life-threatening infectious diseases and to manufacture drugs of the highest social priority.

Lupin first gained recognition when it became one of the world’s largest manufacturers of tuberculosis drugs.^[28] The company today has a significant market share in key markets in the cardiovascular (prils and statins), Diabetology, asthma, pediatrics, CNS, GI, anti-infectives and NSAIDs therapy segments. It also has a global leadership position in the anti-TB and Cephalosporin segments. The company’s R&D endeavours have resulted in significant progress in its new chemical entity (NCE) program. Lupin’s foray into advanced drug delivery systems has resulted in the development of platform technologies that are being used to develop value-added generic pharmaceuticals. Its manufacturing facilities, spread across India and Japan, have played a critical role in enabling the company realize its global aspirations. Benchmarked to International standards, these facilities are approved by international regulatory agencies including the US FDA, UK MHRA, Japan’s MHLW, TGA Australia, WHO, and the MCC South Africa.

Research and development

Lupin’s research program covers the entire pharma value chain. The company’s global R&D program is headquartered in the Lupin Research Park located near Pune that houses over 1400 scientists. Lupin’s R&D covers:

• Generics Research

• Process Research
• Pharmaceutical Research

• Advanced Drug Delivery Systems (ADDS) Research
• Intellectual Property Management
• Novel Drug Discovery and Development (NDDD)
• Biotechnology Research

Businesses

Lupin’s businesses encompass the entire pharmaceutical value chain, ranging from branded and generic formulations, APIs, advanced drug delivery systems to biotechnology. The company’s drugs reach 70 countries^[29] with a footprint that covers Advanced Markets such as USA, Europe, Japan,^[30] Australia as well as Emerging Markets including India,^[31] the Philippines and South Africa to name a few.

Key markets and businesses

USA
Headquartered in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. (LPI), the company's US subsidiary is a $803 million enterprise.^[32] LPI has a presence in the branded and generics markets of the US. In the branded business, Lupin operates in the CVS and Pediatric segments. The company is the market leader in 30 products out of the 74 products marketed in the US generics market, of which it is amongst the Top 3 by market share in 57 of these products (IMS Health, September 2014): Suprax (Cefixime), a paediatric antibiotic, is Lupin’s top-selling product here. The company is also the 5th largest and fastest growing generics player in the US (5.3% market share by prescriptions, IMS Health). Lupin's US brands business contributed 10% of total US sales whereas the generics business contributed 90% during FY 2013-14.^[33]

India Region Formulations (IRF)
Lupin’s IRF business focuses on lifestyle and chronic therapy segments. The company has emerged as one of the fastest growing players in therapies like Cardiology, Central Nervous System (CNS), Diabetology, Anti-Asthma, Anti-Infective, Gastro Intestinal and Oncology. The IRF business contributed 22% of the company’s overall revenues for FY 2013-14, growing by 5% and recording revenues of 25141 million (US$400 million) for FY 2013-14 as compared to 23840 million (US$380 million) for FY 2012-13.

There are 10 manufacturing plant and 2 Research pant in India, such as Jammu(J&K),Mandideep & Indore(Madhya pradesh), Ankaleswar & Dabasa (Gujarat), Tarapur, Aurangabad and Nagpur (Maharastra) and Goa; where research centre at Pune and Aurangabad.^[34] Among these the baby plant is Nagpur plant which will the biggest formulation unit for Lupin in coming year.

Europe
Lupin’s focus in the European Union encompasses Anti-Infectives, Cardiovascular, and CNS therapy areas, along with niche opportunities in segments like Oral Contraceptives, Dermatology and Ophthalmics. The company’s presence in France is by way of a trade partnership; in Germany, it operates through its acquired entity Hormosan Pharma GmbH (Hormosan);^[35] while the UK business is a direct-to-market initiative.

Japan
Lupin is the fastest-growing Top 10 generic pharmaceuticals player in Japan (IMS). Lupin operates in Japan through its subsidiary, Kyowa Pharmaceutical Industry Co. Ltd. (Kyowa), a company Lupin acquired in 2007,^[36][37] and I’rom, Pharmaceutical Co. Ltd (IP), acquired in 2011.^[38][39] Kyowa has an active presence in Neurology, Cardiovascular, Gastroenterology and the Respiratory therapy segments. I'rom is a niche injectables company with significant presence in the DPC hospital segment.

In 2014, Lupin entered into a strategic joint venture agreement with Toyama based Japanese pharmaceuticals company, Yoshindo Inc. to create an entity, YL Biologics (YLB).^[40] YLB will be jointly managed by both partners and wil be responsible for conducting clinical development of certain biosimilars including regulatory fillings and obtaining marketing authorization in Japan.

South Africa
Lupin's South African subsidiary, Pharma Dynamics (PD)^[41] is the fastest growing and the 5th largest generic company in the South African market (IMS). The company is a market leader in the Cardiovascular segment and has a growing presence in Neurology, Gastroenterology and the Over the Counter (OTC) segments.

Australia
Lupin entered the Australian market through its subsidiary, Generic Health Pte. Ltd. (GH).^[42] It subsequently acquired the worldwide marketing rights to the over 100 year old Australian brand Goanna,^[43] used for pain management.

Philippines
Lupin's Philippines subsidiary Multicare Pharmaceuticals (Multicare),^[44] is a branded generic company focused on Women's Health, Pediatrics, Gastro-Intestinal and Diabetes care. FY 2012 also marked its foray into the Neurology segment when it entered into a strategic marketing partnership with Sanofi.^[45]

Mexico & Latin America
In 2014, Lupin acquired 100% equity stake in Laboratories Grin, S.A. De C.V. (Grin), Mexico, a specialty pharmaceutical company engaged in the development, manufacturing & commercialization of branded Opthalmic products. This marked their entry into Mexico and the larger Latin American pharmaceuticals market.

API and Global TB

Lupin is one of the most vertically integrated global generic majors and a global leader in Cephalosporins, Cardiovasculars and the anti-TB space. The company is also a strategic supplier of anti-TB products to the Global Drug Facility (GDF), with its formulations being supplied to more than 50 countries through GDF procurement.

Lupin is also a global leader in anti-TB APIs, and is associated with the Revised National TB Program of the Government of India, thereby partnering the Government in its fight against TB in the country. It also supplies to various Government agencies, the Stop TB Partnership and various other international agencies like Pan America Health Organisation (PAHO), Médecins Sans Frontières (MSF) and the Damien Foundation. Ethambutol, Rifampicin and Pyrazinamide are the company’s top selling TB molecules.

Biotechnology research
The Lupin Biotechnology Research Group, based out of Wakad, near Pune is focussed on developing affordable, high quality biopharmaceuticals with an emphasis on biosimilars. As of May 2013, it has a pipeline of 10 biosimilar products under development, and is close to getting marketing authorization for 2 of its oncology products for the Indian market. Lupin has competencies for the complete development and manufacture of recombinant protein therapeutic products from high yielding and proprietary microbial and mammalian cell culture platforms. The Biotech R&D infrastructure offers a range of product development capabilities ranging from clone development, process optimization, analytical method development, bioassay, formulation, stability studies, non-clinical and clinical studies backed by a sound understanding of regulatory and IP aspects. The company’s biotech development programs are in compliance of and follow ICH, EMEA and Indian Regulatory guidelines.

Corporate social responsibility

To further its social responsibility objectives, Lupin established the Lupin Human Welfare & Research Foundation (LHWRF) on 2 October 1988. Its chief objective was to provide an alternative sustainable, replicable and ever evolving model of holistic rural development. LHWRF started with a few small rural development projects covering around 35 villages in Bharatpur District, Rajasthan. Its efforts have touched the lives of over a million people across 3100 villages in the states of Rajasthan, Madhya Pradesh, Maharashtra and Uttarakhand.

References