Biocon gets USFDA EIR for Visakhapatnam API facility
Bangalore: Biocon has announced that the Company has received an Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) from the U.S. Food and Drug Administration (USFDA), for API facility (Site 5), located at Visakhapatnam, Andhra Pradesh.
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
This is based on a GMP inspection conducted by the agency between the 17th and 21st of June, 2024.
"Biocon remains committed to Quality, Safety & Efficacy of the products manufactured," the Company stated in a BSE filing.
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Biocon Limited, publicly listed in 2004, is an innovation-led, global biopharmaceutical company. It has developed and commercialized novel biologics, biosimilars and complex small molecule APIs in India and several key global markets, as well as generic formulations in the US and Europe.
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