Lupin gets 4 USFDA observations for Pune Biotech facility
Mumbai: Lupin has announced that the company has received four observations from the U.S. Food and Drug Administration (USFDA) after an inspection at the Company’s Pune Biotech facility.
The product-specific Pre-Approval Inspection was conducted from September 08 to September 19, 2025.
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.
Read also: Lupin Secures CDSCO Panel Nod for Phase IV Trial of Budesonide-Based COPD Inhaler
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