Biocon gets zero UFSDA observations for Hyderabad facility

Published On 2023-05-22 06:42 GMT   |   Update On 2023-05-22 06:52 GMT
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Bangalore: Biocon has announced that the US Food and Drug Administration (USFDA) has completed a pre-approval inspection at the Company's Hyderabad facility with no observations.

“This is to inform you that the US FDA concluded a pre-approval inspection for Site 3, Biocon Limited, located at Hyderabad, Telangana, on 19 May 2023, with no observations,” the company informed in a BSE filing.
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Medical Dialogues team had earlier reported that the USFDA had concluded a pre-approval inspection with 3 observations at the company's facility situated in Hyderabad.

Read also: Biocon gets 3 USFDA observations for Hyderabad facility

Biocon Limited is an Indian biopharmaceutical company headquartered in Bangalore. It was founded by Kiran Mazumdar-Shaw in 1978. 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 U.S. and Europe. It also has a pipeline of novel assets in immunotherapy under development. Biocon’s biosimilars business is through its subsidiary, Biocon Biologics Ltd.

Read also: Biocon Biologics Bengaluru facility gets EU GMP certification for Bevacizumab





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