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(28 Apr 2025, 12:58)

USFDA concludes inspection of Time-Cap Laboratories' manufacturing facility in New York


Marksans Pharma announced that a current Good Manufacturing Practices (cGMP) inspection was conducted by the USFDA at the manufacturing facility of the Company's wholly owned subsidiary Time-Cap Laboratories, Inc. located at 7, Michael Avenue, Farmingdale, New York, USA (“the Subsidiary”) from 16 April 2025 to 24 April 2025.

On conclusion of the inspection, the Subsidiary has received One (1) inspectional observation in Form 483. There is no data integrity observation. The Subsidiary will work closely with the USFDA and is committed to address the observation comprehensively within the stipulated time.

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