Lupin Bioresearch Center Achieves Zero Observations from U.S. FDA Following Successful Inspection and Assessment

Mumbai, November 8, 2025: Lupin Limited, a leading global pharmaceutical company, announced that the United States Food and Drug Administration (U.S. FDA) has completed an onsite clinical inspection at its Bioresearch Centre in Pune from November 3 to November 6, 2025, concluding with zero Form 483 observations. In addition, a bio-analytical Remote Regulatory Assessment (RRA) conducted between October 30 and November 7, 2025, also ended with no findings.

Nilesh Gupta, Managing Director of Lupin, stated, “The positive outcome of both the onsite clinical inspection and the bio-analytical assessment by the U.S. FDA underscores our unwavering commitment to quality, compliance, and scientific excellence. We continue striving to enhance patient lives across global markets.”

About Lupin Lupin Limited is a globally recognized pharmaceutical organization headquartered in Mumbai, India, serving over 100 markets worldwide. The company offers a wide range of products, including branded and generic formulations, complex generics, biotechnology products, and APIs. With strong market positions in India and the U.S., Lupin caters to therapy areas such as respiratory, cardiovascular, diabetes, anti-infectives, gastrointestinal disorders, CNS, and women’s health. The company operates 15 advanced manufacturing facilities and 7 R&D centers worldwide, supported by more than 24,000 professionals. Through its subsidiaries — Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions — it continues to drive improved global health outcomes.