USFDA concludes inspection at Biocon Bengaluru API facility
Bangalore: Biocon has announced that the U.S. Food and Drug Administration (US FDA) has concluded a surveillance inspection at the Company's API facility (Site 1), located at Bengaluru, Karnataka.
The inspection was conducted between the 16th to 20th September 2024.
"Three 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 arm gets USFDA nod for chronic heart failure drug Sacubitril/Valsartan
Medical Dialogues team had earlier reported that the USFDA had concluded a combined cGMP inspection and PreLicensing Inspection (PLI) at Biocon Biologics' facilities at Biocon Park, Bengaluru, India.
Read also: USFDA concludes inspection at Biocon Biologics Bengaluru facilities
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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