USFDA conducts product specific pre-approval inspection at Lupin’s Aurangabad facility

Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe

The USFDA has conducted a product-specific Pre-Approval Inspection (PAI) at Lupin Ltd's Chhatrapati Sambhajinagar (Aurangabad) manufacturing facility from September 01 to September 05, 2025. The inspection closed with two observations.

Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe. The company is committed to be compliant with CGMP quality standards across all our facilities.