Biocon gets EIR with VAI status from USFDA for Bengaluru API facility
Bangalore: In a recent BSE filing, Biocon has informed that the U.S. Food and Drug Administration (US FDA) has issued an Establishment Inspection Report (EIR) with a
Voluntary Action Indicated (VAI) status for the Company’s Bengaluru API
facility.
This is based on a surveillance inspection conducted by the agency between the 23rd to 27th of September,
2024.
“This is to inform you that the Company has received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the U.S. Food and Drug Administration (US FDA), for our API facility (Site 2), located at SEZ Plot no. 2,3,4 and 5 Bommasandra-Jigani Link Road, Bengaluru, Karnataka,” the Company stated.
VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
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.
Read also: USFDA classifies Biocon Biologics Biocon Park Site in Bengaluru as VAI
