Biocon Biologics Bengaluru facility classified as VAI by USFDA

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-11-27 06:03 GMT   |   Update On 2025-11-27 06:03 GMT
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Bengaluru: Biocon has announced that the U.S. Food and Drug Administration (FDA) CDER-OC, Office of Manufacturing Quality, has classified Biocon Biologics’ Drug Substance Facility at Biocon Campus, located in Bengaluru, Karnataka, as Voluntary Action Indicated (VAI).

VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. 

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This relates to the inspection conducted by the agency between August 26 to September 3, 2025, and pertains to the manufacture and supply of Human Recombinant Insulin (rh- Insulin) and Biosimilar Pegfilgrastim Drug Substance to the United States. 

Read also: Biocon Pharma gets USFDA nod for arthritis drug Tofacitinib ER

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.

Read also: Biocon expects 50 percent drop in costs for developing complex biosimilars: Top executive

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