Lupin Bioresearch Centre completes fifth successful US-FDA inspection

Mumbai: Pharma major, Lupin Limited has announced the successful completion of the United States Food and Drug Administration (US-FDA) inspection at its Lupin Bioresearch Centre (LBC) without any observations. This is the fifth successive inspection without any 483 observations, indicating superior quality compliance maintained at this global bioresearch facility.

Lupin Bioresearch Centre (LBC) conducts the in-vivo and in-vitro bioequivalence studies for Lupin in Pune. This inspection also included a review of studies done at the center’s new site at Lupin Research Park, Pune.

Commenting on the successful inspection, Mr Nilesh Gupta, Managing Director, Lupin expressed satisfaction about the quality management system maintained in LBC and said: “Such a high level of compliance reiterates Lupin’s commitment to high-quality standards across its world-class research centers.”

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products, and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds a global leadership position in the Anti-TB segment.