Mumbai, November 8, 2025: Lupin Limited, a global pharmaceutical major, reported that the U.S. Food and Drug Administration (U.S. FDA) has concluded an onsite clinical inspection at its Bioresearch Centre in Pune from November 3 to November 6, 2025, with zero 483 observations recorded. The Centre also underwent a bio-analytical Remote Regulatory Assessment from October 30 to November 7, 2025, which closed without any observations.
Nilesh Gupta, Managing Director, Lupin, remarked, “The clean results from both the onsite inspection and the remote assessment highlight the strength of our systems and our continued commitment to world-class quality and compliance. Our efforts remain centered on enhancing patient outcomes globally.”
About Lupin
Based in Mumbai, India, Lupin Limited is a global pharmaceutical company serving over 100 markets. Its product portfolio spans branded and generic formulations, complex generics, biotechnology products, and APIs. Lupin holds leadership positions across India and the U.S. in various therapeutic categories, including respiratory, cardiovascular, diabetes care, anti-infective therapy, gastrointestinal conditions, CNS disorders, and women’s health. The company operates 15 modern manufacturing facilities and 7 research centers globally, supported by a dedicated workforce exceeding 24,000. Its subsidiaries - Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions - continue to strengthen its commitment to better patient health worldwide.
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