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This demonstrates the company’s ability to meet cGMP and aseptic drug-product manufacturing standards.
October 28, 2025
By: Rachel Klemovitch
Assistant Editor
Kemwell Biopharma (Kemwell), a global biologics Contract Development and Manufacturing Organization (CDMO), announced that its drug-product manufacturing facility in Bengaluru has completed a U.S. Food and Drug Administration (FDA) pre-approval inspection (PAI) and is now cleared for the commercial manufacturing and testing of injectable products destined for the U.S. market. The inspection was conducted as part of a Pre-Approval Inspection (PAI) following the transfer of product technology f...
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