Lupin Bioresearch Center Receives Zero Observations from U.S. FDA After Successful Inspection and Assessment

Mumbai, November 8, 2025: Global pharma major Lupin Limited (Lupin) today 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.”

About Lupin  
Lupin Limited is a global pharmaceutical leader 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. Trusted by healthcare professionals and consumers globally, the company enjoys 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, along with a dedicated workforce of over 24,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries - Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. 
To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin

For further information or queries please contact –
Rajalakshmi Azariah 
Vice President & Global Head – Corporate Communications, Lupin  
rajalakshmiazariah@lupin.com