Biocon gets 4 USFDA observations for Bengaluru facility
Bangalore: Biocon has announced that the U.S Food and Drug Administration (US FDA) has concluded a surveillance inspection with four observations at the Company's API facility (Site 2), located at Bengaluru, Karnataka.
The inspection was held between the 23rd to 27th September 2024.
Read also: USFDA concludes inspection at Biocon Biologics Malaysia Insulins facility
Medical Dialogues team had earlier reported that the Company had received three observations at the end of the inspection at the Company's API facility (Site 1), located at Bengaluru, Karnataka.
Read also: USFDA concludes inspection at Biocon Bengaluru API facility
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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