Lupin’s Somerset Manufacturing Plant Receives EIR from US FDA

#Lupin #Pharmaceuticals #USFDA

Source: Lupin

“We are very happy to have received the EIR from US FDA with satisfactory VAI classification for our Somerset facility.” - Vinita Gupta, CEO, Lupin

July 2022 : Global pharma major Lupin Limited (Lupin) recently announced that it has received the Establishment Inspection Report (EIR) from United States Food and Drug Administration (US FDA) for its Somerset, NJ manufacturing facility, after the inspection of the facility in March 2022. The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).

Vinita Gupta, CEO, 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 progress, Nilesh Gupta, Managing Director, 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 the 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.”