By Dr. Kamal Kant Kohli,Ruchika Sharma
Copyright medicaldialogues
Mumbai: Lupin has announced that the U.S. Food and Drugs Administration (USFDA) has closed the inspection with six observations at the company’s Nagpur Injectable facility.The inspection was held from September 8 to September 16, 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 Manufacturing Solutions: Empagliflozin API gets CADIFA approval from ANVISA, BrazilLupin 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 gets 2 USFDA observations for Aurangabad facility
