USFDA issues EIR for Lupin Somerset facility

Mumbai: Global pharma major Lupin Limited today announced that it has 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, with a Voluntary Action Indicated (VAI) status.

Voluntary action indicated (VAI), which means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

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.

Medical Dialogues team had earlier reported that U.S. FDA had concluded a Pre Approval Inspection with an issuance of a Form-483 with six observations at Lupin’s Somerset, New Jersey manufacturing facility.

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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 the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The Company specializes 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. The company invested 7.8% of its revenue in research and development in FY24. Lupin has 15 manufacturing sites, 7 research centers.

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