Mumbai, November 15, 2025: Global pharma major Lupin Limited (Lupin) today announced that the United States Food and Drug Administration (U.S. FDA) has completed a product specific Pre-Approval Inspection at its Unit-1 oral solid dosage manufacturing facility in Nagpur. The inspection was carried out from November 10 to November 14, 2025, and concluded with zero 483 observations.

Nilesh Gupta, Managing Director, Lupin said, “The successful outcome of the U.S. FDA inspection at our Nagpur Unit-1 facility exemplifies our commitment to uphold and maintain the highest standards of quality, compliance, and safety across our facilities. We remain dedicated to 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