The first update relates to a Good Clinical Practices (GCP) compliance inspection conducted at Syngene’s Semicon Park facility, Bengaluru, from June 9 to June 13, 2025. The inspection concluded with zero observations, and no Form 483 was issued. The inspection was classified as “No Action Indicated” (NAI), signifying full compliance with regulatory expectations.
In a separate development, the USFDA also concluded its review of an earlier inspection held between February 10 and February 20, 2025, at Syngene’s GMP manufacturing facilities in Biocon Park, SEZ, Bengaluru. The company received the Establishment Inspection Report (EIR) on June 11, 2025. The inspection was classified as “Voluntary Action Indicated” (VAI), and the USFDA has accepted Syngene’s responses and Corrective and Preventive Action (CAPA) plans submitted in response to the inspectional findings.
These updates indicate regulatory progress and compliance, which could be seen positively by the market.
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The company has stated that it will continue to provide periodic updates to the USFDA and remains committed to the highest standards of compliance. It also clarified that the inspection outcomes will not have any adverse impact on its financials or operations.
In a separate regulatory filing, the company also confirmed the resignation of Ms. Priyadarshini Mahapatra from the position of Head Legal, Company Secretary & Compliance Officer, effective from the close of business hours on June 9, 2025. Her resignation was previously communicated on April 23, 2025.
Syngene International shares closed 1.6% lower at Rs 652.50 on the BSE.
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