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INCOG Manufacturing Facility Receives FDA Approval to Produce Drug Product

The approval comes after a rigorous inspection of INCOG's facility and quality systems.

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By: Charlie Sternberg

Associate Editor

INCOG BioPharma Services’ sterile injectable manufacturing facility has received approval from the U.S. Food and Drug Administration (FDA) to produce a commercially approved drug product.   The FDA approval comes after a rigorous inspection of INCOG’s facility and quality systems, during which INCOG demonstrated compliance with FDA requirements for aseptic manufacturing. Notably, the inspection resulted in zero Form 483 observations, underscoring the company’s commitment to excelle...

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