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Biocon has announced that the U.S. Food and Drug Administration (US FDA) has concluded an inspection with two observations at its API facility (Site 6), located at Visakhapatnam, Andhra Pradesh.A GMP surveillance inspection was conducted between 3rd and 7th November, 2025."Two observations were cited at the end of the inspection, which the Company will be addressing within the stipulated time. The Company does not foresee any impact on the business," Biocon stated in a BSE filing.Read also: Biocon Told to Submit Detailed Toxicity, SAE Data on Semaglutide Prefilled Pen After Animal DeathsBiocon Limited, publicly listed in 2004, is a 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.
