Mumbai: Lupin has announced that the company has received one observation from the U.S. Food and Drug Administration (USFDA) after a Pre-Approval Inspection at its manufacturing facility located in Somerset, New Jersey, U.S.A.
10, 2025.
committed to be compliant with CGMP standards across all our facilities,” the company stated in a BSE filing.
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.
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