Lupin’s Nagpur facility gets zero observations from USFDA after pre-approval inspection

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

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.