Lupin gets 2 USFDA observations for Aurangabad facility
Mumbai: Lupin has received two observations from the U.S. Food and Drug Administration (USFDA) at the closure of an inspection at the Company's Chhatrapati Sambhajinagar (Aurangabad) manufacturing facility.
The product-specific Pre-Approval Inspection (PAI) was held from September 01 to September 05, 2025.
"We will address the observations and respond to the U.S. FDA within the stipulated timeframe. We are committed to be compliant with CGMP quality standards across all our facilities," the company stated in a BSE filing.
Read also: Lupin wins USFDA nod for Risperidone for extended-release injectable suspension for schizophrenia
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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