Lupin Nagpur injectable facility gets EIR from USFDA
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-12-17 06:00 GMT | Update On 2025-12-17 06:00 GMT
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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 (US FDA) for its injectable facility in Nagpur, India, with a satisfactory Voluntary Action Indicated (VAI) classification.
VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
Nilesh Gupta, Managing Director, Lupin, said, “We are pleased to have received the EIR from the U.S. FDA with a VAI classification for our Nagpur injectable facility. We are committed to upholding the highest standards of quality and compliance across our facilities, with continued focus on enhancements to our quality systems and operational excellence.”
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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