News about "Office of Manufacturing Quality"

US FDA Classifies Biocon Biologics' Bengaluru Drug Substance Facility as VAI

US FDA Classifies Biocon Biologics' Bengaluru Drug Substance Facility as VAI

The US FDA has classified Biocon Biologics’ Bengaluru drug substance facility as Voluntary Action Indicated (VAI) following an inspection in August–September 2025. The review covers the site’s production of rh-Insulin and biosimilar Pegfilgrastim for the US market.

Office Of Manufacturing Quality | 29/11/2025 | By Dineshwori 111


 

 

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