USFDA issues EIR for Lupin Nagpur Unit-1 manufacturing facility
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 Nagpur Unit-1 manufacturing facility that manufactures oral solid dosage forms. The EIR was issued post the last inspection of the facility conducted in July 2023. The U.S. FDA has determined that...
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 Nagpur Unit-1 manufacturing facility that manufactures oral solid dosage forms. The EIR was issued post the last inspection of the facility conducted in July 2023. The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).
Voluntary action indicated (VAI), means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
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“We are pleased to receive the EIR with a VAI status from the U.S. FDA for the recent inspection of our Nagpur Unit-1 facility. This achievement underscores our commitment to quality and compliance and also mirrors our core values, reaffirming our commitment to providing high-quality healthcare solutions to our patients around the world,” said Nilesh Gupta, Managing Director, Lupin.
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 7.9% of its revenue in research and development in FY23.
Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.
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