Lupin gets USFDA EIR for Pithampur Unit 3 facility

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-11-06 05:30 GMT | Update On 2025-11-06 06:10 GMT

Mumbai: Global pharma major Lupin Limited has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for its Pithampur Unit-3 facility, following an inspection from July 7 to July 17, 2025.

The facility manufactures metered dose inhalers, dry powder inhalers, topical formulations, and nasal solutions.

Nilesh Gupta, Managing Director,

Lupin said, “We are pleased to have received the EIR from the U.S. FDA for our Pithampur Unit-3 facility. This demonstrates our commitment to maintaining the highest standards of compliance and quality, as we aim to deliver high-quality, affordable medicines from world-class factories for patients worldwide.”

Lupin Limited is a global pharmaceutical company 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. The company has 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.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Lupin gets USFDA EIR for Pithampur Unit 3 facility

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