# Cambrex High Point Completes FDA, PMDA and TGA Pre-Approval Inspections, Advancing Commercial Manufacturing Capabilities

- Link: https://www.thailand-business-news.com/pr-news/cambrex-high-point-completes-fda-pmda-and-tga-pre-approval-inspections-advancing-commercial-manufacturing-capabilities
- Published: 2026-08-25T17:00:00+07:00
- Author: PR Newswire

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EAST RUTHERFORD, N.J., Aug. 25, 2026 /PRNewswire/ — Cambrex, a leading global contract
development and manufacturing organization (CDMO), today announced the successful
completion of three 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 completion of all three inspections enables High Point to manufacture 
approved active pharmaceutical ingredients (APIs) for the United States, Japan, 
and Australia, establishing the facility as the newest commercial manufacturing 
site within the Cambrex global network.

PAIs are conducted by regulatory agencies to assess a facility’s quality systems,
manufacturing processes, data integrity, and operational controls before commercial
products can be approved for manufacture at the site.

The milestone follows Cambrex’s $38 million expansion of the High Point facility
completed in 2023, which added analytical and chemical development laboratories,
clinical manufacturing suites, and commercial manufacturing operations with reactors
up to 2,000 liters. The site is designed to support lower-volume commercial products,
including orphan drugs, precision medicines, and other specialized therapies serving
smaller patient populations.

"Successfully completing these inspections demonstrates the strength of our quality
systems and the dedication of the High Point team," said Thomas Loewald, Chief Executive
Officer, Cambrex. "As more therapies are developed for targeted patient populations,
the industry increasingly requires commercial manufacturing capacity at smaller 
scales. High Point was purpose-built to meet that need, providing customers with
an efficient and flexible path from development to long-term commercial supply."

High Point complements Cambrex’s global development and manufacturing network by
providing customers with a seamless path from process development and clinical manufacturing
through commercial production. The addition of commercial manufacturing capabilities
in North Carolina further expands the company’s ability to support customer programs
throughout the product lifecycle.

**About Cambrex**
Cambrex is a leading global contract development and manufacturing
organization (CDMO) that provides drug substance development and manufacturing across
the entire drug lifecycle, as well as comprehensive analytical services.

With over 45 years of experience and a team of 2,000 experts servicing global clients
from North America and Europe, Cambrex offers a range of specialized drug substance
technologies and capabilities, including continuous flow, controlled substances,
peptide synthesis, solid-state science, biocatalysis, material characterization,
complex synthetics, and highly potent APIs.

 

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