Syngene International Ltd updates on USFDA inspection at Biocon Park, SEZ, Bengaluru

The company has announced pursuant to the inspection conducted by the United States Food & Drug Administration (USFDA) from February 10, 2025, to February 20, 2025, in connection with the routine current Good Manufacturing Practices (cGMP) inspection at Syngene International Ltd's GMP manufacturing facilities located at Biocon Park, SEZ, Bengaluru. The Company has received Establishment Inspection Report (EIR) from 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 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.

Shares of Syngene International Limited was last trading in BSE at Rs. 652.50 as compared to the previous close of Rs. 662.90. The total number of shares traded during the day was 11391 in over 649 trades.

The stock hit an intraday high of Rs. 661.60 and intraday low of 651.05. The net turnover during the day was Rs. 7467496.00.

Source : Equity Bulls

Keywords

SyngeneInternational INE398R01022 Pharmaceuticals USFDA Inspection GMP BioconPark SEZ Bengaluru