November 09, 2025

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Biocon gets 2 USFDA observations for Visakhapatnam facility

Biocon has announced thatthe 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 surveillanceinspection was conducted between 3rd and 7thNovember, 2025. Biocon 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.

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