Lupin gets USFDA EIR for Dabhasa facility
Mumbai: Global pharma major Lupin Limited has announced that the Company has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for its manufacturing facility located in Dabhasa, Gujarat.
The EIR was issued post the last inspection of the facility conducted from April 8 to April 12, 2024.
The inspection concluded with no observations and the facility receiving an inspection classification of “No Action Indicated” (NAI).
The facility is a part of Lupin Manufacturing Solutions (LMS), which is engaged in the development, manufacture and sale of Active Pharmaceutical Ingredients and Contract Development and Manufacturing Operations.
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“We are pleased to receive the EIR for Dabhasa from the U.S. FDA,” said Nilesh Gupta, Managing Director, Lupin. “This achievement is in line with our continued focus and commitment to maintaining the highest standards of quality and compliance in all aspects of our operations. This reaffirms our pursuit of delivering high-quality, affordable healthcare solutions to our patients globally.”
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.8% of its revenue in research and development in FY24. Lupin has 15 manufacturing sites, 7 research centers.
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