The United States Food and Drug Administration (USFDA) conducted a pre-approval and cGMP inspection at Syngene International’s Bengaluru facility, covering commercial manufacturing activities for the US market. The inspection took place from February 10, 2025, to February 20, 2025.

Following the inspection, the USFDA issued Form 483 with five observations. Syngene International has stated that it will work closely with the USFDA and is committed to addressing these observations comprehensively within the stipulated time.

Syngene International provides contract research and manufacturing services, ranging from lead generation to clinical supplies, for pharmaceutical and biotechnology companies worldwide.