HIGH POINT, N.C. – Cambrex’s High Point pharmaceutical manufacturing facility can now produce approved active pharmaceutical ingredients for the U.S., Japan and Australia after completing three regulatory pre-approval inspections.
The company said the High Point site completed inspections by the U.S. Food and Drug Administration, Japan’s Pharmaceuticals and Medical Devices Agency and Australia’s Therapeutic Goods Administration. Cambrex said the milestone makes High Point the newest commercial manufacturing site in its global network.
Pre-approval inspections examine a facility’s quality systems, manufacturing processes, data integrity and operational controls before commercial products can be approved for manufacture at the site.
The new capability builds on a $38 million expansion Cambrex completed in High Point in 2023. That project added analytical and chemical development laboratories, clinical manufacturing suites and commercial manufacturing operations with reactors up to 2,000 liters. The $38 million was a prior investment and is not new spending announced this week.
Cambrex said the High Point operation is designed for lower-volume commercial products, including orphan drugs, precision medicines and other specialized therapies for smaller patient populations.
The Aug. 25 announcement did not include a new hiring commitment, capital investment or named commercial product tied to the inspection milestone.