Generic Research – (Active Pharmaceutical Ingredient and Finished Product)
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 U.S.
Our approach is to invest ahead of the curve to advance Lupin’s global generic R&D pipeline through significant investments in the complex generic platform technologies. With the commissioning of the new global R&D hub in Pune, India, Lupin hosts one of the most advanced pharmaceutical product development and pilot plant facilities for oral, ophthalmic, dermatology and inhalation product development.
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).
Formulations research is supported by the API process research group, which comprises 150 scientists and 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).
- New R&D hub in Pune, India
- 300+ scientists and chemists
- Focus on high entry barrier products
Our Generic Pharmaceutical Research Team has recorded a stellar performance with a record number of ANDA filings in the U.S. and other advanced markets. The company filed 21 ANDAs for FY20, comprising oral, injectable, ophthalmic, inhalation and dermatology dosage forms and 2 NDAs. The U.S. FDA has approved 14 ANDAs and 18 products have been launched in the U.S. market. Lupin also filed 11 generic products in other advanced markets like EMEA (Europe, South Africa, Russia), APAC (Japan and Australia), LATAM (Mexico and Brazil) and Canada. Ten filings have been approved in these markets.