Lupin announced that the United States Food and Drug Administration (U.S. FDA) has completed a product specific Pre Approval Inspection at its Unit-1 oral solid dosage manufacturing facility in Nagpur. The inspection was carried out from 10 November to 14 November 2025, and concluded with zero 483 observations.

Nilesh Gupta, Managing Director, Lupin said, “The successful outcome of the U.S. FDA inspection at our Nagpur Unit-1 facility exemplifies our commitment to uphold and maintain the highest standards of quality, compliance, and safety across our facilities. We remain dedicated to improving the lives of our patients globally.”