Biocon gets zero UFSDA observations for Hyderabad facility

Written by Ruchika Sharma Published On 2023-05-22T12:12:44+05:30 | Updated On 22 May 2023 12:22 PM IST

Biocon gets zero UFSDA observations for Hyderabad facility

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.

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.

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.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751