The EIR was issued with an inspection classification of voluntary action indicated (VAI) post the inspection of the facility from 16 September to 27 September 2024.
Nilesh Gupta, MD, Lupin said, “We are pleased to receive the EIR from the US FDA for our Pithampur Unit-1 facility with a satisfactory VAI classification. This reflects our commitment to the highest standards of quality and compliance.”
Mumbai-based Lupin is an innovation-led transnational pharmaceutical company. It develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
Lupin’s consolidated net profit jumped 74.1% to Rs 852.63 crore on 11.3% increase in sales to Rs 5,497.01 crore in Q2 FY25 over Q2 FY24.
Shares of Lupin rose 0.56% to currently trade at Rs 2,261 on the BSE.