Lupin Limited announced its Bioresearch Center in Pune received zero observations from the U.S. Food and Drug Administration (FDA) following a clinical inspection from November 3 to November 6, 2025. A bio-analytical Remote Regulatory Assessment from October 30 to November 7, 2025, also concluded with no observations. This outcome highlights Lupin’s commitment to quality and compliance in its research facilities.
FDA Inspection Outcome
Lupin Limited (Lupin) announced that the United States Food and Drug Administration (U.S. FDA) has completed an onsite clinical inspection at its Bioresearch Centre in Pune. The inspection, conducted from November 3 to November 6, 2025, concluded with zero 483 observations.
Bio-analytical Assessment
Prior to the onsite inspection, a bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025. This assessment similarly concluded with no observations.
Management Commentary
Nilesh Gupta, Managing Director, Lupin, stated, “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.”
About Lupin
Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with products distributed in over 100 markets. The company specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 24,000 professionals.
Source: BSE
