Syngene International shares in focus after positive USFDA updates for 2 Bengaluru facilities
Syngene International shares: The company received two important updates from the U.S. Food and Drug Administration (USFDA).
Syngene International shares:The initial update concerns a Good Clinical Practices (GCP) compliance inspection carried out at Syngene's Semicon Park facility in Bengaluru between June 9 and June 13, 2025. The inspection resulted in no findings, and no Form 483 was issued. It was classified as 'No Action Indicated' (NAI), indicating full adherence to regulatory standards.
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Shares of Syngene International are expected to be in focus on Monday, June 16, 2025, after the company received two significant updates from the United States Food and Drug Administration (USFDA) concerning inspections at its facilities in Bengaluru.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.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.: Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of The Economic Times)
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