Global pharmaceutical company Lupin Limited announced that it has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its Pithampur Unit-3 manufacturing facility. The report follows a successful inspection conducted in July 2025.
The Pithampur Unit-3 facility manufactures a range of products, including metered dose inhalers, dry powder inhalers, topical formulations, and nasal solutions.
Expressing his views, Nilesh Gupta, Managing Director of Lupin, said, “We are delighted to receive the EIR from the U.S. FDA for our Pithampur Unit-3 facility. This recognition reinforces our dedication to maintaining world-class quality and compliance standards, ensuring that we continue to provide affordable, high-quality medicines to patients globally.”
Headquartered in Mumbai, India, Lupin Limited is a leading global pharmaceutical company with a presence in over 100 markets. The company develops and manufactures a wide range of generic and branded formulations as well as active pharmaceutical ingredients (APIs). Lupin holds strong market positions in India and the United States across key therapeutic segments, including respiratory, cardiovascular, diabetes, anti-infective, gastrointestinal, central nervous system, and women’s health. The company operates 15 advanced manufacturing facilities and 7 research centres worldwide.