Cambrex, a New Jersey-based contract development and manufacturing organization (CDMO), has completed pre-approval inspections by the U.S. Food and Drug Administration, Japan’s Pharmaceuticals and Medical Devices Agency, and Australia’s Therapeutic Goods Administration at its High Point, North Carolina facility, allowing the site to manufacture approved active pharmaceutical ingredients (APIs) for the three markets.

The inspections evaluated the facility’s quality systems, manufacturing processes, data integrity, and operational controls ahead of commercial manufacturing approvals. According to Cambrex, High Point is now the newest commercial manufacturing site in its global network.

The milestone follows a $38 million expansion completed in 2023 that added analytical and chemical development laboratories, clinical manufacturing suites, and commercial manufacturing operations with reactors up to 2,000 liters. The facility is designed to support lower-volume commercial products, including orphan drugs, precision medicines, and other therapies for smaller patient populations.

The site provides development, clinical manufacturing, and commercial production capabilities within the same facility. Cambrex said the addition of commercial manufacturing expands its ability to support small-molecule programs through multiple stages of the product lifecycle.

In a related development, Cambrex began construction earlier this month on a $30 million research and development facility at its Milan, Italy site. The project will add analytical development and process R&D capabilities and upgrade multiple production facilities, with completion expected in the second half of 2027.

The Milan expansion is part of a broader investment program that also includes a planned $120 million API manufacturing facility at Cambrex’s Charles City, Iowa site. The Iowa project is expected to add 140,000 liters of capacity and support complex chemistry, including controlled substances, highly potent APIs, and commercial-scale liquid-phase peptide manufacturing.