USFDA Inspects Syngene's GCP Compliance in Bengaluru Facility

• USFDA completed GCP inspection at Syngene's Semicon Park with zero observations
• Biocon Park facility's earlier GMP inspection concluded with a VAI classification
• Company confirms no financial or operational impact from the inspection results

Syngene International shares are expected to be in focus after two major regulatory statements by the United States Food and Drug Administration (USFDA) on inspections at the company's Bengaluru-based facilities.

One such inspection, in Good Clinical Practices (GCP) at Syngene's Semicon Park facility between June 9-13, was concluded without any observations. The USFDA did not issue any Form 483 and rated the inspection No Action Indicated (NAI), a top industry compliance rating implying total compliance with regulatory norms.

In another notification, USFDA has also finished reviewing a prior GMP inspection done for the manufacturing facilities from February 10 to 20, 2025, at Syngene's Biocon Park, SEZ facility. Syngene received the Final Establishment Inspection Report (EIR) dated June 11, which classified the result as Voluntary Action Indicated (VAI). The agency also has accepted the company's submitted Corrective and Preventive Action (CAPA) plans, closing the cycle of inspection without escalation or fines.

Also Read: India's Pharma Sector Faces Heightened FDA Scrutiny on Quality

Syngene stressed that these outcomes will not produce any adverse financial or operating impacts and reiterated its history of high compliance and quality levels.

Independently, in a regulatory filing, Syngene has stated that Ms. Priyadarshini Mahapatra, Head Legal, Company Secretary & Compliance Officer, had resigned on June 9, 2025, after giving notice of resignation on April 23.

The stock of Syngene closed lower by 1.6 percent at Rs. 652.50 on the BSE after Friday's trading ended.