Global pharmaceutical major Lupin Limited announced that the U.S. Food and Drug Administration (US FDA) has successfully completed an onsite clinical inspection at its Bioresearch Centre in Pune, with zero 483 observations. The inspection was conducted from November 3 to November 6, 2025, and marks another strong compliance milestone for the company.
In addition to the onsite inspection, a bio-analytical Remote Regulatory Assessment was carried out by the US FDA between October 30 and November 7, 2025, which also concluded with no observations, underscoring Lupin’s high standards of quality and operational excellence.
Commenting on the achievement, Nilesh Gupta, Managing Director of Lupin, said, “The successful outcome of the onsite clinical inspection and bio-analytical assessment by the U.S. FDA at our Bioresearch Centre is testament to our ongoing commitment to quality and compliance. We remain focused on improving the lives of our patients globally.”
