Cambrex completes FDA, PMDA, and TGA inspections in North Carolina

Cambrex, a global contract development and manufacturing organization (CDMO), has successfully completed three Pre-Approval Inspections (PAIs) at its facility in High Point, North Carolina. The inspections were conducted by the U.S. Food and Drug Administration (FDA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and Australia's Therapeutic Goods Administration (TGA).

These regulatory assessments confirm the facility's quality systems, manufacturing processes, and operational controls. The successful completion allows the High Point site to manufacture approved active pharmaceutical ingredients (APIs) for the United States, Japan, and Australia markets.

The milestone follows a $38 million expansion of the High Point facility completed in 2023. The site is specifically designed to support lower-volume commercial products, such as orphan drugs and precision medicines, catering to specialized therapies for smaller patient populations.