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2 clusters · 6 sources · 8 days · First seen · Last updated

Cambrex global manufacturing and R&D expansion

Overview

The contract development and manufacturing organization (CDMO) Cambrex has undertaken several global expansion and regulatory milestones.

In August 2026, Cambrex announced the start of construction on a $30 million research and development facility in Milan, Italy, intended to improve analytical development and process R&D. This project is expected to be finished in the second half of 2027.

Concurrently, Cambrex’s facility in High Point, North Carolina, successfully completed Pre-Approval Inspections (PAIs) 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). These inspections confirm the site’s ability to manufacture approved active pharmaceutical ingredients (APIs) for the United States, Japan, and Australia markets, following a $38 million expansion of the site in 2023.

Entities

Therapeutic Goods Administration · WuXi XDC · Cambrex · Pharmaceuticals and Medical Devices Agency · Cambrex Corp.

Timeline

  1. 30 days ago

    [BUSINESS] 4 sources
    Cambrex completes FDA, PMDA, and TGA inspections in North Carolina

    Cambrex has completed regulatory inspections by the FDA, PMDA, and TGA at its High Point, North Carolina facility, enabling the production of approved APIs for the US, Japanese, and Australian markets.

  2. about 1 month ago

    [BUSINESS] 2 sources
    Cambrex and WuXi XDC expand global CDMO manufacturing and R&D capabilities

    CDMOs Cambrex and WuXi XDC are expanding global operations through a new $30 million R&D facility in Italy and a GMP-released production line in Singapore.

Sources

bioprocessintl.com · chemengonline.com · ltvnews.net · news.cube-soft.jp · vir.com.vn · zdnet.co.kr