Global pharma major Lupin 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).

“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,” said Vinita Gupta, CEO, Lupin.

Commenting on the development, 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.”

Lupin, an innovation-led transnational pharmaceutical 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 company enjoys leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women’s health areas. The company has 15 manufacturing sites, 7 research centres, and more than 20,000 professionals working globally.