Syngene's Bengaluru unit passes US FDA test but with VAI classification

Leading contract research and manufacturing organisation, Syngene Ltd, on Friday (June 13) said it has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) following a routine inspection of its GMP manufacturing facilities at Biocon Park, SEZ, Bengaluru.

"We hereby inform you that the company has received the Establishment Inspection Report (EIR) from the USFDA vide its communication dated June 11, 2025. The EIR concluded the inspectional outcome as Voluntary Action Indicated (VAI). The US FDA has reviewed and accepted Syngene’s responses and Corrective and Preventive Action (CAPA) plans submitted in response to the inspectional findings," Syngene said in a regulatory filing.

The inspection, which took place between February 10-20, concluded with a classification of voluntary action indicated (VAI). The company said the FDA has reviewed and accepted its responses, along with the Corrective and Preventive Action (CAPA) plans submitted after the inspection.

Also Read: Syngene Q4 Results: Profit beats estimates, revenue misses Street

The company confirmed that it will continue to provide the agency with periodic updates on the progress of its corrective actions. It also clarified that the outcome of the inspection will not affect its financials or day-to-day operations.

"Syngene will continue to provide periodic updates to the USFDA on the progress of corrective actions submitted to the agency. We remain committed to maintaining the highest standards of regulatory compliance and this outcome will not have any adverse impact on the Company’s financials or operations," it added.

What is voluntary action indicated (VAI)?

VAI licks in when violations are found, but the problems do not justify further regulatory action. Improving GMP compliance is voluntary in this case. The facility can continue selling approved drugs and will also receive approvals for new filings.

Also Read: Syngene Q3 Results | Net profit rises 18% to ₹131 crore, revenue up 11% to ₹944 crore

Shares of Syngene Ltd ended at ₹652.45, down by ₹10.45, or 1.58%, on the BSE.