Lupin's Nagpur facility clears FDA inspection with no observations

Lupin Limited confirmed today that the U.S. Food and Drug Administration (FDA) has concluded a Pre-Approval Inspection at its Unit-1 oral solid dosage manufacturing facility in Nagpur with zero Form 483 observations. The inspection, which focused on a product-specific review, took place from November 10 to November 14, 2025.

Nilesh Gupta, managing director of Lupin, highlighted that this successful outcome underscores the company's unwavering commitment to maintaining the highest standards of quality, compliance, and safety across all its facilities. This positive result is expected to reinforce confidence in Lupin's manufacturing processes.

Lupin is a global pharmaceutical company with products distributed in over 100 markets, specializing in various pharmaceutical products, including branded and generic formulations. The company operates 15 manufacturing sites and 7 research centers globally, supported by a workforce exceeding 24,000 professionals.