Cambrex has completed pre-approval inspections by the U.S. FDA, Japan’s Pharmaceuticals and Medical Devices Agency and Australia’s Therapeutic Goods Administration at its High Point, North Carolina facility, enabling the site to manufacture approved active pharmaceutical ingredients for the three markets.
The inspections establish High Point as the newest commercial manufacturing site in Cambrex’s global contract development and manufacturing network. The company said the facility can now support commercial API manufacturing for the United States, Japan and Australia.
Pre-approval inspections are conducted by regulatory authorities before commercial products can be approved for manufacturing at a facility. The inspections assess quality systems, manufacturing processes, data integrity and operational controls.
The milestone follows a $38 million expansion of the High Point site completed in 2023. The project added analytical and chemical development laboratories, clinical manufacturing suites and commercial manufacturing operations with reactors of up to 2,000 liters.
Cambrex said the facility was designed for lower-volume commercial products, including orphan drugs, precision medicines and other specialized therapies intended for smaller patient populations. The company said these types of programs require commercial manufacturing capacity at smaller scales as development increasingly focuses on targeted patient groups.
Thomas Loewald, Cambrex’s chief executive officer, said completion of the three inspections reflects the facility’s quality systems and the work of the High Point team.
“As more therapies are developed for targeted patient populations, the industry increasingly requires commercial manufacturing capacity at smaller scales,” Loewald said. He said the site was built to provide customers with an efficient and flexible route from development through long-term commercial supply.
High Point will complement Cambrex’s wider development and manufacturing network, providing customers with a path from process development and clinical manufacturing to commercial production. The new commercial capabilities in North Carolina expand Cambrex’s capacity to support customer programs across the product life cycle.