Lupin has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its manufacturing facility in Somerset, New Jersey, with a Voluntary Action Indicated (VAI) status.

The facility was inspected from May 7 to May 17, 2024.

“We are very pleased to have received the EIR with a satisfactory VAI status for our Somerset facility. This is a significant milestone in building our reputation of being best-in-class in Quality and Compliance,” said Nilesh Gupta, Managing Director, Lupin.

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 US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a 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 US by prescriptions. The company invested 7.8 percent of its revenue in research and development in FY24.