Lupins Somerset facility gets EIR from USFDA

7 Jul 2022 , 09:34 AM

The inspection was conducted in March 2022. The United States Food and Drug Administration (USFDA) has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI). Vinita Gupta, CEO of Lupin, said, ?We are very happy to have received the EIR from US FDA with satisfactory VAI classification for our Somerset facility. This is a significant milestone for our Somerset site, and an important step in our journey to build back our reputation as best in class in Quality and Compliance. We are committed to manufacture and supply products of the highest quality for the patients we serve,? Commenting on the development, Nilesh Gupta, managing director of Lupin said, ?We remain committed to meet and exceed global standards of quality and compliance at all our manufacturing sites. We are very happy to have received the EIR for our Somerset facility with Voluntary Action Indicated status from US FDA. With this positive development, we now look forward towards building a sustainable business from our Somerset facility, and carry this momentum to positive outcomes for our other sites.? Lupin is a transnational pharmaceutical company. The company 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 Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions. The pharma giant reported a consolidated net loss of Rs 518 crore in Q4 FY22 as against a net profit of Rs 460.4 crore in Q4 FY21. Income from operations rose by 2.8% year on year to Rs 3,864.5 crore during the quarter. Shares of Lupin were up 0.14% at Rs 631 on the BSE. Powered by Capital Market – Live News