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OVERVIEW

WE ARE LIVING IN AN ERA OF UNPARALLELED SCIENTIFIC PROGRESS AND TECHNOLOGY ADVANCES. THE GLOBAL PHARMACEUTICAL INDUSTRY IS ON THE CUSP OF AN ERA OF SIGNIFICANT TRANSFORMATION. NO LONGER IS IT BEING SHAPED BY JUST AGING POPULATIONS, SPIRALING HEALTHCARE COSTS, INCREASE IN CHRONIC DISEASES OR CHANGE IN DISEASE PATTERNS, BUT ALSO BY DISCOVERIES, INVENTIONS IN TECHNOLOGY, COMMUNICATIONS, SYSTEMS AND SOFTWARE.

The world of life sciences is converging like never before and the convergence of pharmaceutical, biotechnology and medical technology would improve outcomes that could dramatically alter drug development and delivery.

Today, over 1700 Lupin scientists spread across research hubs in India, US, Japan and Europe are working to make Lupin a key part of this evolving journey of Innovation. We are excited about the possibilities of what can be; pushing boundaries to broaden our understanding to create quality products that improve and simplify delivery and access. That is why Lupin is stepping on the gas and investing ahead of the curve. FY 2016 was a remarkable transformational year for our Research and Development, where the Company upped the ante by investing Rs. 17,318 million in Research & Development (R&D) programs.

We have had 10 years of sustained growth built on our investments in research. We have mined our experiences, learning from our failures as much as from our successes in our quest to bring relevant products and technologies to our markets globally. That is Lupin’s Alchemy for Growth.

Key Highlights , FY 2016

  • Global Phase III comparative clinical trial for Etanercept on track across geographies such as Japan and multiple countries within the European Union
  • Completed Phase-I PK/PD trial for 2 products and pre-clinical studies for 2 products in India
  • Scale-up and technology transfer for 5 products successfully mediated from research to commercial
  • Successful commercialization of its first two Oncology biosimilars in India - Lupifil® (Filgrastim) and Lupifil-P® (Peg-Filgrastim) in India
  • Received milestone payments of USD 3 million for 2 of its products that are being jointly developed with Medicis Pharmaceuticals Corporation, now Valeant.
  • Filed 36 ANDAs (20 oral, 10 dermatology, 2 ophthalmic, 1 inhalation and 3 other products), including 2 First-to-File (FTF) products with the US FDA. The Company received 39 approvals in FY 2016.
  • Filed 16 US DMFs. Additionally filed 3 EDMF, 2 CEP and 2 Japan DMFs
  • Successfully launched the generic versions of Glumetza®, Intermezzo®, Loestrin® 24 Fe, Phoslo Gelcaps®, Generess®, Mircette®, Lofibra®, Ortho Tri-Cyclen Lo® to name a few.
  • Lupin’s state-of-the-art R&D facility in Coral Springs, Florida was inaugurated in August, 2015.