EAST RUTHERFORD, New Jersey — August 25, 2026
Cambrex announced the successful completion of 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). The regulatory milestone strengthens the facility’s readiness for commercial API manufacturing for the United States, Japan and Australia and establishes High Point as the newest commercial manufacturing site within Cambrex’s global network. The inspections evaluated the facility’s quality systems, manufacturing processes, data integrity and operational controls, providing an important regulatory step toward supporting approved products at commercial scale.
High Point Expands Commercial API Manufacturing Capacity
Completion of the three regulatory inspections significantly expands the role of the High Point facility within Cambrex’s manufacturing network. The site was expanded through a $38 million investment completed in 2023, adding analytical and chemical development laboratories, clinical manufacturing suites and commercial manufacturing capabilities with reactors of up to 2,000 liters. The facility is specifically designed to support lower-volume commercial products, including orphan drugs, precision medicines and other specialized therapies serving smaller patient populations. For cGxP.wire, the key manufacturing development is the transition of High Point from development and clinical manufacturing capabilities toward commercial API production for multiple regulated international markets.
Multi-Agency Inspections Strengthen Global Supply Capabilities
The completion of PAIs by the FDA, PMDA and TGA demonstrates the facility’s readiness to meet regulatory expectations across three major pharmaceutical markets. Pre-Approval Inspections are an important part of the regulatory process because agencies assess whether a manufacturing site can consistently operate according to required quality and compliance standards before commercial products can be manufactured there. High Point’s successful completion of inspections therefore enhances Cambrex’s ability to provide customers with a more integrated path from process development and clinical manufacturing to commercial supply. The facility also complements the company’s broader network across North America and Europe, supporting pharmaceutical programs throughout their development and commercial lifecycle.
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Cambrex Targets Specialized and Lower-Volume Therapies
The High Point expansion addresses a growing manufacturing requirement created by the increasing development of targeted therapies, orphan drugs and precision medicines. These products often require commercial manufacturing capacity at smaller scales rather than the very large production volumes associated with traditional medicines. Cambrex said the High Point facility was purpose-built to provide customers with flexible and efficient commercial manufacturing capacity for these specialized products. With more than 45 years of experience and approximately 2,000 employees, Cambrex provides drug substance development, manufacturing and analytical services across the pharmaceutical lifecycle. Its capabilities include continuous flow, peptide synthesis, biocatalysis, solid-state science, complex synthetics and highly potent APIs, positioning the High Point site as an additional component of the company’s global CDMO infrastructure.
Source:Cambrex ,press relese
