#USA #FDA #Cambrex #High Point #TGA

Cambrex High Point Successfully Completes Regulatory Inspections

In a significant achievement, Cambrex, a prominent global contract development and manufacturing organization (CDMO), has successfully passed three key Pre-Approval Inspections (PAIs) at its High Point facility located in North Carolina. These inspections were conducted by the U.S. Food and Drug Administration (FDA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and Australia's Therapeutic Goods Administration (TGA). This accomplishment positions High Point to manufacture approved active pharmaceutical ingredients (APIs) for markets in the U.S., Japan, and Australia, thereby establishing the site as a new commercial manufacturing hub within Cambrex's expansive global network.

The PAIs are critical assessments carried out by regulatory authorities to evaluate a facility's quality systems, manufacturing processes, data integrity, and operational controls, all of which are essential before allowing the manufacturing of commercial products.

This milestone follows an impressive $38 million investment in the High Point facility, completed in 2023. This upgrade included the addition of advanced analytical and chemical development laboratories, clinical manufacturing suites, and commercial manufacturing operations equipped with reactors capable of accommodating up to 2,000 liters. The facility is particularly tailored to support lower-volume commercial products, notably orphan drugs and precision medicines designed for specialized therapies targeting smaller patient populations.

Thomas Loewald, CEO of Cambrex, emphasized the significance of this accomplishment, stating, "Successfully completing these inspections demonstrates the strength of our quality systems and the dedication of the High Point team. As the industry increasingly develops therapies for targeted patient populations, the demand for commercial manufacturing capacity at smaller scales is on the rise. High Point was purpose-built to meet this need, providing our customers with an efficient and flexible pathway from development to long-term commercial supply."

The High Point site enhances Cambrex's global development and manufacturing network, offering clients a seamless transition from process development and clinical manufacturing to commercial production. The addition of these manufacturing capabilities in North Carolina broadens the company's reach and strengthens its ability to support customer programs throughout the entire product lifecycle.

Cambrex boasts over 45 years of experience in the pharmaceutical sector, employing a dedicated team of 2,000 experts who support clients across North America and Europe. The organization is committed to providing a range of specialized drug substance technologies and capabilities, including continuous flow production, controlled substances, peptide synthesis, solid-state science, biocatalysis, material characterization, complex synthetics, and the development of highly potent APIs.

This remarkable achievement not only underscores Cambrex's dedication to quality and client service but also reinforces its position as a leader in the contract manufacturing landscape, poised to tackle the evolving demands of the global pharmaceutical industry.

As high-demand medicines continue to emerge, Cambrex High Point is set to play a crucial role in advancing the commercial manufacturing landscape, ensuring that vital therapies reach patients who need them the most.