Lupin’s stock gained over 2% in Monday’s trade after the company announced that the U.S. Food and Drug Administration (US FDA) successfully completed an onsite clinical inspection at its Bioresearch Centre in Pune with zero Form 483 observations. As of 9:57 AM, the shares were trading 2.28% higher at Rs 2,016.80.
The inspection, conducted between November 3 and November 6, 2025, marks yet another major compliance milestone for the pharmaceutical company, reinforcing its strong regulatory track record.
In addition to the onsite visit, the US FDA also carried out a bio-analytical Remote Regulatory Assessment from October 30 to November 7, 2025, which concluded with no observations. This outcome highlights Lupin’s consistent focus on maintaining the highest standards of quality, compliance, and operational excellence.
Commenting on the development, Nilesh Gupta, Managing Director of Lupin, said, “The successful outcome of the onsite clinical inspection and bio-analytical assessment by the U.S. FDA at our Bioresearch Centre is testament to our ongoing commitment to quality and compliance. We remain focused on improving the lives of our patients globally.”
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