MARKETS

Syngene International Shares Gain 1% on Zero Observations

The inspection yielded 0 observations, and no Form 483 was issued.
The inspection yielded 0 observations, and no Form 483 was issued.

The share price of Syngene International Ltd rose 1% in early trading on 16 June following zero observations by the United States Food and Drug Administration (USFDA) at the Bengaluru facility.

In its regulatory filing, the company said, “The United States Food and Drug Administration (USFDA) conducted a Good Clinical Practices (GCP) compliance inspection of Syngene International’s facility at Semicon Park, Bengaluru, from 9 June to 13 June 2025.”

The inspection was completed satisfactorily, and the facility was deemed to be in conformity with the applicable rules.

The inspection yielded 0 observations, and no Form 483 was issued. The examination has been designated as No Action Indicated (NAI), it said.

Last week, the business got an Establishment Examination Report (EIR) from the USFDA following a normal current Good Manufacturing Practices (cGMP) examination of GMP manufacturing facilities at Biocon Park, SEZ, Bengaluru, from 10 to 20 February 2025. The EIR determined that the inspection resulted in Voluntary Action Indicated (VAI).

At 1:55 pm, the shares of Syngene International were trading 0.80% higher at Rs 658.35 on NSE.

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