The United States Food and Drug Administration (USFDA) has conducted a pre-approval and cGMP inspection covering commercial manufacturing activities for the US market at Syngene International’s Bengaluru facilities. The inspection conducted from February 10, 2025 to February 20, 2025. On conclusion of the inspection, the USFDA issued Form 483 with 5 observations. The Company will work closely with USFDA and remains committed to addressing these observations comprehensively within the stipulated time.
Syngene International is engaged in providing contract research and manufacturing services from lead generation to clinical supplies to pharmaceutical and biotechnology companies worldwide.
