Syngene International Limited has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its GMP manufacturing facilities located at Biocon Park, SEZ, Bengaluru. This follows the routine current Good Manufacturing Practices (cGMP) inspection conducted between February 10 and February 20, 2025.
As per the EIR dated June 11, 2025, the inspection has been classified as Voluntary Action Indicated (VAI). The USFDA has reviewed and accepted Syngene’s responses along with the Corrective and Preventive Action (CAPA) plans submitted in response to the inspectional observations.
The company will continue to provide periodic updates to the USFDA on the implementation status of the corrective actions. Syngene reiterates its commitment to maintaining the highest standards of regulatory compliance.
This inspection outcome is not expected to have any adverse impact on the Company’s financial performance or operations.
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