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) classification, signifying a satisfactory inspection outcome.
According to the company, the US FDA inspected the facility from April 13 to April 17, 2026.
Commenting on the development, Nilesh Gupta, Managing Director, Lupin, said, “We are pleased to receive the EIR with a VAI classification from the US FDA for our Somerset facility. This outcome reflects our unwavering commitment to quality, compliance, and operational excellence and reinforces our dedication to manufacturing high-quality medicines that patients around the world can trust.”
Headquartered in Mumbai, India, Lupin is a global pharmaceutical company that specialises in branded and generic formulations, complex generics, biotechnology products and active pharmaceutical ingredients. The company has a strong presence in India and the United States across multiple therapeutic areas, including respiratory, cardiovascular, diabetes, anti-infectives, gastrointestinal, central nervous system, and women’s health.
Lupin operates 15 manufacturing facilities and seven research centres worldwide, supported by a workforce of more than 24,000 employees. It also offers healthcare services through its subsidiaries, Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
In the United States, Lupin Pharmaceuticals Inc., established in 2003 in Baltimore, Maryland, has expanded its footprint through manufacturing, research and development, and commercial divisions for generics, complex generics, biosimilars, and branded pharmaceuticals. The company established its Center of Excellence for Inhalation Research in Coral Springs, Florida, in 2015 and, following the acquisition of Novel Laboratories, launched Lupin Somerset, its first US manufacturing facility, during 2017–18.
