Spread across 9 R&D sites in 6 countries, with over 1,700 scientists and more than 3,000 patents filed globally, Lupin is well positioned to cater to the unique requirements of distinct markets. The company’s focus has been to direct R&D spends into areas that reflect the opportunities presented by the markets. The outlay of investments in R&D of Rs 18.5 billion which accounts for 11.9 per cent of net sales during FY2018, is a growth driver to fuel the company’s future. The Company has four R&D Centres namely Research Park, Biotech Centre and BioResearch Centre at Pune and one at Aurangabad.
Key Highlights – FY2018 Filed 36 US ANDAs, received 24 approvals.
Filed 20 generic products in EMEA region (Europe, Middle East and Africa), APAC region (Japan & Australia), Canada and Latin America (Brazil & Mexico) and received 22 approvals; launched 16 new products in these markets.
Submitted 6 US DMFs (Drug Master Files), 2 European DMFs, 3 Japan DMFs.
Completed Phase III Global Clinical Trial of the flagship project Etanercept
Filed the Common Technical Document (CTD) and Application for Marketing Authorization with the Japanese regulatory authority (PMDA),
Received approval for its Biotech’s first Investigational New Drug (IND) in the US for its late phase oncology products.
Biotech division filed 3 new patents in India and
3 Patent Cooperation Treaty (PCT) applications. In addition, 4 patent grants secured, 1 in the US and 3 in South Africa. Novel Drug Discovery & Development (NDDD) team has focused on developing a pipeline of highly differentiated and innovative new chemical entities in the therapeutic areas of Oncology, Immunology and Metabolic disorders.
Successfully secured 63 patents, including 34 Novel Drug Discovery & Development (NDDD) patents. Lupin Bioresearch Centre (LBC) made a rapid progress in new areas of pharmaceutical innovation.