Mumbai: Global pharma major Lupin Limited has announced that the
United States Food and Drug Administration (U.S. FDA) has completed a product specific PreApproval 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.
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.”
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.”
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. The company has 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.
markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics,
biotechnology products, and active pharmaceutical ingredients. The company has 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.
