Generics – (API and Finished Products)
Lupin’s generic R&D pipeline is aimed at developing a comprehensive portfolio of high entry barrier products that address unmet patient needs. Our track record of successful ANDA filings and approvals has garnered us leadership in several chronic therapy areas such respiratory, diabetes and cardiovascular in India, and hypertension and calcium blockers in the US.
Formulations research is supported by the API process research group, which includes 150 scientists supported by an equal number of analytical chemists. The team specialises in the development of processes for the manufacturing of APIs, including intermediates (the key starting material), chemicals and biological (fermentation).
Our Generic Pharmaceutical Research Team has recorded a stellar performance with a record number of ANDA filings in the US and other advanced markets. The company filed 21 ANDAs for FY20, comprising oral, injectable, ophthalmic, inhalation and dermatology dosage forms, and two NDAs. The US FDA has approved 14 ANDAs, and 18 of our products have been launched in the US market. Lupin also filed 11 generic products in other advanced markets such as EMEA (Europe, South Africa, Russia), APAC (Japan and Australia), LATAM (Mexico and Brazil) and Canada. Ten filings have been approved in these markets.