Cambrex completed three Pre-Approval Inspections (PAIs) at its High Point, North Carolina, facility on Aug. 25, 2026, conducted by the FDA (U.S. drug regulator), Japan's PMDA (Japan’s medicines regulator) and Australia's TGA (Australia’s medicines regulator). The inspections enable the site to manufacture approved active pharmaceutical ingredients (APIs) for the United States, Japan and Australia, making High Point the newest commercial manufacturing site in Cambrex's global network. The milestone follows a $38 million expansion completed in 2023 that added analytical and chemical development laboratories, clinical manufacturing suites and commercial operations with reactors of up to 2,000 liters. Designed for lower-volume commercial products such as orphan drugs, precision medicines and other specialized therapies, the site is intended to support smaller patient populations and provide a path from development and clinical manufacturing to long-term commercial supply.