Lupin Bioresearch Center gets zero USFDA observation after successful inspection, assessment
Mumbai: Lupin Limited, a Global pharma major, has announced that the United States Food and Drug Administration (U.S. FDA) has completed an onsite clinical inspection from November 3 to November 6, 2025, at its Bioresearch Centre in Pune that concluded with zero 483 observations.
A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations.
Nilesh Gupta, Managing Director, 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.”
Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company has a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally.
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