Lupin Receives USFDA EIR for New Jersey Plant with VAI Classification
Mumbai: Global pharma major Lupin Limited (Lupin) has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its manufacturing facility in Somerset, New Jersey, with a satisfactory Voluntary Action Indicated (VAI) classification.
The inspection was conducted from April 13, 2026, to April 17, 2026.
Nilesh Gupta, Managing Director, Lupin, said, “We are pleased to receive the EIR with a VAI classification from the U.S. FDA for our Somerset facility. This outcome reflects our unwavering commitment to quality, compliance, and operational excellence, and reinforces our dedication to manufacturing highquality medicines that patients around the world can trust.”
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 24,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries - Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
