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Generic Pharmaceutical and API Research

Yet again, Lupin's Generic Pharmaceutical Research team has demonstrated a stellar performance with a record number of ANDA filings in US and other advanced markets from its global R&D hub in Pune, India. With the commissioning of the new R&D building at Pune, India, Lupin can now boast of one of the most advanced pharmaceutical product development & pilot plant facilities for oral, ophthalmic, dermatology and inhalation product development. This facility will be leading future innovations aimed at creating a highly differentiated global pipeline of complex generics.

The Company’s generic pipeline is focused on identifying and developing high entry barrier products with complexities linked with delivery system, device compatibility and clinical trial requirement. Simultaneously, we continue to bolster our oral solids pipeline in view of upcoming patent expiration as well as market needs thereby providing a balanced mix to the pipeline.

The formulations research is supported by API Process Research Group. This includes 150 scientists assisted by equal number of analytical chemists who specialize in the development of processes for the manufacturing of APIs including intermediates, key starting material, chemicals and biological (fermentation).

Lupin's process research consists of chemical technologies, including chemical synthesis, semi-synthetic fermentation, enzymatic synthesis and high potent API development. Furthermore, it also champions the advanced research in solid-state particle technology and polymorphism.

Highlights, FY 2017

  • Filed 37 ANDAs & 1 NDA (31 oral, 5 dermatology, 1 ophthalmic & 1 metered dose inhaler), including 3 confirmed FTF and 4 potential FTF products with the US FDA. Lupin received 34 ANDA approvals from US FDA during FY 2017. Cumulative ANDA filings with the US FDA now stand at 368 with 214 approvals received to date. Lupin now has total of 45 FTF ANDAs which includes 23 exclusive FTF opportunities
  • Filed 23 generic products in other advanced markets including EMEA (Europe, South Africa & Russia), APAC (Japan & Australia), Canada, Latin America & Mexico and also received 16 approvals in these markets
  • Filed 15 DMFs, taking the cumulative filings to 187. Additionally, filed 3 PEPFAR DMFs and 2 CEP filings.