The inspection was conducted over a two-week period, from 29 September to 10 October 2025, and concluded with one observation.
Lupin confirmed that it will address the FDA’s observation promptly and submit a comprehensive response within the stipulated regulatory timeframe.
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 an 11.78% increase in income from operations to Rs 6,163.75 crore in Q1 FY26 over Q1 FY25.
Shares of Lupin rose 0.11% to end at Rs 1,959.70 on Friday, 10 October 2025.