Mumbai, November 12, 2025: Lupin Limited (Lupin), a global pharmaceutical major, announced today that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for its Chhatrapati Sambhajinagar (Aurangabad) facility. The EIR was issued following a product-specific Pre-Approval Inspection carried out from September 1 to September 5, 2025.
Nilesh Gupta, Managing Director, Lupin, stated, “We are pleased with the receipt of the EIR from the U.S. FDA for our Aurangabad facility. This achievement reflects our ongoing commitment to quality, compliance, and delivering trusted healthcare solutions to patients across the globe.”
About Lupin
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with its products marketed in over 100 countries. The company specializes in a wide range of pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers worldwide, Lupin has a strong presence in India and the U.S. across multiple therapy areas such as respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. The company operates 15 state-of-the-art manufacturing facilities and 7 research centers globally, supported by a workforce of more than 24,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries—Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
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