The milestone arrives following a $38 million infrastructure investment finalized in 2023. The expansion equipped the plant with chemical development laboratories and specialized manufacturing suites featuring reactors with capacities up to 2,000 liters. These upgrades were specifically engineered to handle low-volume production, targeting the growing niche of orphan drugs and precision medicines that serve smaller patient cohorts.
Cambrex Clears Regulatory Hurdles for High Point Manufacturing Site
The High Point, North Carolina facility has secured green lights from the FDA, Japan’s PMDA, and Australia’s TGA, marking a pivot for the site from clinical testing to full-scale commercial production. This triple regulatory clearance allows Cambrex to supply active pharmaceutical ingredients across three major international markets.
Thomas Loewald, CEO of Cambrex, noted that the site’s design addresses a specific industry shift toward targeted, smaller-scale therapies. By integrating commercial production into the existing High Point ecosystem, the company offers a continuous lifecycle path for its clients, spanning from initial process development through long-term supply. This transition establishes the North Carolina location as a core component of the company’s global manufacturing network, which now leverages 45 years of sector experience to manage complex drug substance requirements.
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