Lupin Receives EIR With VAI Status From U.S. FDA For Somerset Facility

Global pharmaceutical major Lupin  (Lupin) received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for its manufacturing facility in Somerset, New Jersey. 

In a press statement on Monday, the company informed that the facility has been granted a Voluntary Action Indicated (VAI) status following an inspection that took place from May 7 to May 17, 2024.

Nilesh Gupta, Managing Director of Lupin, expressed his satisfaction with the outcome, “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.”

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The company develops and commercialises a wide range of branded and generic formulations, biotechnology products, and APIs across over 100 markets, including the U.S., India, South Africa, Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East. 

Lupin holds a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastrointestinal (GI), central nervous system (CNS), and women’s health areas. It is the third-largest pharmaceutical company in the U.S. by prescriptions. In FY24, the company invested 7.8 per cent of its revenue in research and development.