The EIR was issued following an inspection of the facility from 08 September 2025 to 16 September 2025.

Nilesh Gupta, managing director, Lupin, said: “We are pleased to have received the EIR from the U.S. FDA with a VAI classification for our Nagpur injectable facility.

We are committed to upholding the highest standards of quality and compliance across our facilities, with continued focus on enhancements to our quality systems and operational excellence.”

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 had reported a 73.33% surge in consolidated net profit to Rs 1,477.92 crore in Q2 FY26 as against Rs 852.63 crore posted in Q2 FY25. Revenue from operations jumped 24.27% year-on-year to Rs 6,831.43 crore in the quarter ended 30 September 2025.

The counter rose 0.84% to currently trade at Rs 2107.20 on the BSE.