Cambrex High Point Site Clears FDA, PMDA, TGA Inspections

Editor’s Take: North Carolina remains a hotbed for pharma investment. Genentech, AbbVie, Johnson & Johnson and more have made investments in facilities there this year.

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

PAIs are conducted by regulatory agencies to assess a facility’s quality systems, manufacturing processes, data integrity, and operational controls before commercial products can be approved for manufacture at the site.

The completion of all three inspections enables High Point to manufacture approved active pharmaceutical ingredients (APIs) for the United States, Japan, and Australia, establishing the facility as the newest commercial manufacturing site within the Cambrex global network. The site is designed to support lower-volume commercial products, including orphan drugs, precision medicines, and other specialized therapies serving smaller patient populations.

“Successfully completing these inspections demonstrates the strength of our quality systems and the dedication of the High Point team,” said Thomas Loewald, CEO, Cambrex. “As more therapies are developed for targeted patient populations, the industry increasingly requires commercial manufacturing capacity at smaller scales. High Point was purpose-built to meet that need, providing customers with an efficient and flexible path from development to long-term commercial supply.”

More Cambrex News

Earlier this year, Cambrex completed the initial engineering studies for its new, large-scale API manufacturing plant in Charles City, Iowa, and started construction on a new R&D facility in Milan.