SECTOR
Lupin’s Bioresearch Center gets zero observations from USFDA after successful inspection
Nov-08-2025

The United States Food and Drug Administration (USFDA) has completed an onsite clinical inspection from November 3, 2025 to November 6, 2025, at Lupin’s Bioresearch Centre in Pune that concluded with zero 483 observations. A bio-analytical Remote Regulatory Assessment was also conducted from October 30, 2025 to November 7, 2025, and concluded with no observations.

The successful outcome of the onsite clinical inspection and bio-analytical assessment by the USFDA at its Bioresearch Centre is testament to the company’s ongoing commitment to quality and compliance. The company remains focused on improving the lives of its patients globally. 

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.


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