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Generic Pharmaceutical and API Research

For Lupin's Generic Pharmaceutical Research team at its Global R&D hub in Pune, India, FY2018 has been another year of strong performance in terms of the number of ANDA filings in US and other advanced markets. The year also marked a successful foray into the injectable space with the filing of our first injectable ANDAs in the US in addition to ANDA filings in the Oral, Ophthalmic, Dermatology and Inhalation space.

The Company’s generic pipeline in the Oral Space holds key focus on developing complex products in view of upcoming patent expirations or market needs. This is complemented by a comprehensive pipeline of high entry barrier products with complexities linked with a delivery system, device design and clinical trial requirements in the inhalation and injectable space. Our constant quest is to design a balanced pipeline of products to establish Lupin as a meaningful Complex Generics player while continuing to hold its leadership generic position in markets like the US.

Process Research, the Company is developing APIs for Complex Generics and is preparing for development of peptides and Hormonal APIs in the coming year. The Company is vigorously pursuing its initiative in Biocatalysis and Fermentation based processes for APIs.

The Company’s Analytical Research facility is fully automated and equipped with state-of-the-art technology. Apart from the newly established Extractable & Leachable laboratory, the facility is equipped with latest equipments ranging from Differential Scanning Calorimetry, Dynamic Vapor Absorption System, Scanning Electron Microscope, Raman Spectroscopy System and Automated preparative HPLCs to name a few.

Key Highlights – FY2018

Filed 36 ANDAs (26 Orals, 4 Injectables, 2 Dermatology, 2 Ophthalmic and 2 Inhalation), including 2 confirmed exclusive First-to-file (FTF), 6 shared FTFs and 2 First-to-market (FTM) opportunities with US FDA. During the year, Lupin received 24 ANDA approvals from the US FDA

Filed 20 generic products in other advanced markets including the EMEA region (Europe, Middle East and Africa), APAC region (Japan & Australia), Canada and Latin America (Brazil & Mexico) and received 22 approvals in these geographies. In FY2018, the Company launched 16 new products in these markets

Submission of 6 US DMFs, 2 EDMFs, 3 Japan DMFs. Also completed exhibit batches for 1 filing each in Japan and GIB as well as the first Oncology DMF