Lupin announces closure of inspection by U.S. FDA at its Nagpur facility with no observations
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Global pharma major Lupin Limited, in an exchange filing 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 November 10 to November 14, 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.”
This development comes after the pharma company announced on November 13 that it has achieved an S&P Global ESG Score of 91 for 2025, well above the pharmaceutical industry average of 28. Lupin is part of an exclusive group of companies worldwide that have surpassed the 90-point mark.
"This remarkable increase from 17 in 2021 ranks among the fastest for pharmaceutical companies, establishing Lupin as a leader in sustainable growth," the statement read.
Lupin posted its Q2 results for the current financial year, with gross profit at ₹5006.6 crore compared to ₹3807.1 Mn in Q2 FY2025, with a gross margin of 73.3%. Personnel cost was 16.2% of sales at ₹1105.6 crore compared to ₹1007.5 crore in Q2 FY2025.
November 2025
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Manufacturing and other expenses were 29.0% of sales at ₹1979.6 crore compared to ₹1667 crore in Q2 FY2025. PBT stood at ₹2007 crore at 29.4%, up 90.3% YoY from ₹1054.9 crore in Q2 FY2025. Investment in R&D for the quarter was ₹509.1 crore (7.5% of sales).