Biocon gets 3 USFDA observations for Hyderabad facility
New Delhi: Pharma major, Biocon has recently announced that the US Food and Drug Administration (USFDA) has concluded a pre-approval inspection with 3 observations at the company's facility situated in Hyderabad.
"US FDA concluded a pre-approval inspection for Site 3, Biocon Limited, located at Hyderabad, Telangana on 20 July 2022. Three observations were cited at the end of the Inspection, which we will be addressing within the stipulated time," the company stated in a BSE filing.
"Biocon stands committed to the Quality, Safety & Efficacy of its products," the company further stated.
Read also: Biocon Biologics gets EU GMP certificate for new Bengaluru facility
Biocon Limited is an innovation-led global biopharmaceuticals company headquartered in Bangalore. 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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