United States Food and Drug Administration (USFDA) has conducted a Good Clinical Practices (GCP) compliance inspection of Syngene International’s facility at Semicon Park, Bengaluru, from June 09, 2025 to June 13, 2025.
The inspection concluded successfully, with the facility found to be in compliance with the required regulations. The inspection resulted in zero observations and no Form 483 was issued. The inspection has been classified as No Action Indicated (NAI). The company remains commitment to high operating standards and rigorous compliance with global regulatory requirements across all its operations.
Syngene International is engaged in providing contract research and manufacturing services from lead generation to clinical supplies to pharmaceutical and biotechnology companies worldwide.