Lupin's Nagpur Injectable Facility Receives Satisfactory EIR from US FDA
Lupin Limited has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its injectable facility located in Nagpur, India. The facility has...
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Why is Lupin Limited in the news today?
Lupin Limited (LUPIN) is in the news due to the company received a satisfactory eir from the us fda, indicating compliance with regulatory standards, which is a positive development for its injectable facility.
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Lupin's Nagpur Injectable Facility Receives Satisfactory EIR from US FDA
December 16, 2025, 03:28 PM
Lupin Limited has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its injectable facility located in Nagpur, India. The facility has been classified with a satisfactory Voluntary Action Indicated (VAI) status.
The inspection by the US FDA took place from September 8 to September 16, 2025, and the EIR was subsequently issued. Nilesh Gupta, Managing Director of Lupin, expressed satisfaction with the outcome, stating, "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 operations in over 100 markets. The company focuses on pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.
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