- Cambrex has completed three Pre-Approval Inspections at its High Point, North Carolina facility by the FDA, Japan’s PMDA and Australia’s TGA.
- The inspections enable the facility to manufacture approved APIs for the US, Japan and Australia following a $38 million expansion completed in 2023.
Cambrex has completed three Pre-Approval Inspections (PAIs) at its High Point, North Carolina facility, 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). The completion of the inspections enables the facility to manufacture approved active pharmaceutical ingredients (APIs) for the US, Japan and Australia.
The PAIs assessed the site’s quality systems, manufacturing processes, data integrity and operational controls before commercial products can be approved for manufacture at the facility. Cambrex said the milestone establishes High Point as its newest commercial manufacturing site within its global network.
The development follows a $38 million expansion completed in 2023. The investment added analytical and chemical development laboratories, clinical manufacturing suites and commercial manufacturing operations with reactors of up to 2,000 liters.
The High Point site is designed to support lower-volume commercial products, including orphan drugs, precision medicines and other specialized therapies serving smaller patient populations. The facility provides a path from process development and clinical manufacturing through commercial production.
“Successfully completing these inspections demonstrates the strength of our quality systems and the dedication of the High Point team. As more therapies are developed for targeted patient populations, the industry increasingly requires commercial manufacturing capacity at smaller scales.”
Thomas Loewald, CEO of Cambrex
