According to a regulatory filing, the inspection was carried out from 8 September to 16 September 2025.
The company stated that it will address the observations and respond to the U.S. FDA within the stipulated timeframe. It is committed to complying with CGMP quality standards across all its facilities.
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.