Lupin Limited announced that the U.S. Food and Drug Administration (FDA) has successfully completed a Pre-Approval Inspection at its oral solid dosage manufacturing facility in Nagpur. The inspection, which took place from November 10 to November 14, 2025, concluded with zero 483 observations. This outcome reflects Lupin’s commitment to maintaining high standards of quality and compliance across its manufacturing facilities.
Inspection Closure at Nagpur Facility
Lupin announced the successful completion of a product-specific Pre-Approval Inspection by the United States Food and Drug Administration (U.S. FDA) at its Unit-1 oral solid dosage manufacturing facility in Nagpur. The inspection concluded on November 14, 2025.
Commitment to Quality
According to Nilesh Gupta, Managing Director, Lupin, the successful inspection outcome demonstrates the company’s dedication to upholding the highest standards of quality, compliance, and safety. Lupin remains committed to improving patient lives globally through its high-quality pharmaceutical products.
Source: BSE