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Cambrex High Point Achieves Key Regulatory Milestone

Cambrex, a leading global contract development and manufacturing organization (CDMO), has announced a significant enhancement to its operational capabilities at its High Point facility in North Carolina. The completion of inspections by three major regulatory agencies—the United States Food and Drug Administration (FDA), the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, and the Therapeutic Goods Administration (TGA) of Australia—marks a critical step forward for Cambrex.

On August 25, 2026, Cambrex revealed that its High Point campus has successfully passed all necessary pre-approval inspections, allowing for the manufacturing of active pharmaceutical ingredients (APIs) that have been approved for use in the United States, Japan, and Australia. This achievement positions the High Point facility as the newest commercial manufacturing site in Cambrex's expansive global network.

Importance of Pre-Approval Inspections

Pre-approval inspections (PAIs) are conducted by regulatory bodies to assess various critical aspects of a manufacturing plant. These include quality systems, manufacturing processes, data integrity, and operational controls to ensure that the site meets all necessary safety and efficacy standards before commercial production can commence. The successful completion of these inspections underscores Cambrex's commitment to maintaining high standards of quality in its manufacturing practices.

Expansion of High Point Facility

The recent successful inspections come on the heels of a significant expansion project at the Cambrex High Point facility, which was completed in early 2023. This project required an investment of $38 million and involved the establishment of state-of-the-art analytical and chemical development laboratories, as well as dedicated spaces for clinical and commercial manufacturing operations equipped with reactors up to 2,000 liters. The newly designed center is particularly tailored to support lower-volume commercial products, such as orphan drugs, precision medicines, and specialized therapies aimed at smaller patient populations.

Thomas Loewald, CEO of Cambrex, highlighted the importance of this milestone, stating, “Overcoming these inspections demonstrates the robustness of our quality systems and the dedication of the High Point team. As more therapies are developed for specific patient populations, the industry increasingly needs commercial manufacturing capabilities on a smaller scale. High Point is designed to meet this need, providing customers with an efficient and flexible pathway from development to long-term commercial supply.”

A Comprehensive Network for Development and Manufacturing

The High Point facility is integral to Cambrex’s global development and manufacturing network, facilitating a comprehensive route for clients from process development and clinical manufacturing through to commercial production. With the addition of commercial manufacturing capabilities in North Carolina, Cambrex can further enhance its support for customers throughout their product lifecycle, helping to streamline processes and deliver high-quality solutions.

Cambrex’s reputation as a world leader in CDMO stems from its extensive expertise gleaned over more than 45 years in the industry. The company boasts a team of 2,000 skilled professionals who serve clients across North America and Europe, offering a wide array of specialized capabilities in pharmaceutical substances. These include continuous flow technology, controlled substances, peptide synthesis, solid-state science, biocatalysis, material characterization, complex syntheses, and high-potency APIs.

In conclusion, Cambrex High Point’s successful completion of the FDA, PMDA, and TGA inspections is not just a testament to the facility’s readiness for commercial manufacturing, but also demonstrates the growing demand for efficient and scalable manufacturing solutions in the evolving landscape of global healthcare. This strategic enhancement reinforces Cambrex’s commitment to supporting innovative therapies and therapies that cater to unique patient needs.