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Lupin's Aurangabad-based facility gets two observations from US FDA

Lupin said that the U.S. FDA has conducted a product-specific Pre-Approval Inspection (PAI) at the company's Chhatrapati Sambhajinagar (Aurangabad) manufacturing facility from 01 September 2025 to 05 September 2025.

The company further stated that the said inspection closed with two observations.

We will address the observations and respond to the United States Food and Drug Administration (U.S. FDA) within the stipulated timeframe. We are committed to be compliant with CGMP quality standards across all our facilities, Lupin said in a statement.

Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

The company's consolidated net profit jumped 52.13% to Rs 1,219.03 crore on 11.78% increase in income from operations to Rs 6,163.75 crore in Q1 FY26 over Q1 FY25.

The scrip had gained 0.27% to end at Rs 1944.65 on the BSE on Friday.