FDA changes inspection classification of Somerset facility to Voluntary Action Indicated
Somerset, NJ, Mumbai, July 07, 2022: Global pharma major Lupin Limited (Lupin) today 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).
“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 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 an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. 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 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. Lupin is the third largest pharmaceutical company in the U.S. by prescriptions. The company invested 8.7% of its revenue on research and development in FY22.
Lupin has 15 manufacturing sites, 7 research centres, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.
Please visit www.lupin.com for more information.
For further information or queries please contact –
Vice President & Global Head – Corporate Communications