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USFDA completes cGMP inspection at manufacturing facility of Marksans Pharma’s arm

28 Apr 2025 Evaluate

United States Food and Drug Administration (USFDA) has completed a current Good Manufacturing Practices (cGMP) inspection at the manufacturing facility of Marksans Pharma’s wholly owned subsidiary Time-Cap Laboratories, Inc. located at 7, Michael Avenue, Farmingdale, New York, USA (the Subsidiary) from April 16 2025 to April 24, 2025.

On conclusion of the inspection, the Subsidiary has received 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.

Marksans Pharma is engaged in Research, Manufacturing & Marketing of generic pharmaceutical formulation in the global markets.


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