Lupin Limited announced on July 1, 2026, that it has received the Establishment Inspection Report from the United States Food and Drug Administration for its manufacturing facility in Somerset, New Jersey. The U.S. FDA assigned a Voluntary Action Indicated classification, a satisfactory regulatory outcome for the facility.
The U.S. FDA inspection at the Somerset facility took place from April 13, 2026, to April 17, 2026. Nilesh Gupta, Managing Director of Lupin, said the VAI classification affirms Lupin's focus on quality and compliance in manufacturing medicines for patients globally.
Lupin is a global pharmaceutical company headquartered in Mumbai, India. Lupin distributes products in over 100 markets and specializes in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.
Lupin has a strong position in India and the United States across therapy areas including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin operates 15 manufacturing sites and 7 research centers globally. Lupin employs over 24,000 professionals.
Lupin's subsidiaries include Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. Lupin disclosed this information in a press release filed with the National Stock Exchange of India and BSE Limited on July 1, 2026, in compliance with Regulation 30 of the SEBI Listing Obligations and Disclosure Requirements Regulations, 2015.
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