Carbogen Amcis, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, has completed the first inspection by the French regulatory authority, ANSM, at its sterile drug product manufacturing site in Saint-Beauzire, France.

As a result, Carbogen Amcis has been granted a GMP certificate for the Saint-Beauzire facility, marking a significant milestone in the site’s successful start-up.

“This achievement reflects our team’s dedication and hard work,” said Angie Stevens, Vice President, Drug Product Business Unit. “I am incredibly proud of the commitment and motivation every Saint-Beauzire employee shows. With this certification, we look forward to actively supporting our customers in bringing new drugs to market and shaping a bright future together.”

About the Facility

Opened in early 2023, the Saint-Beauzire facility represents a $65 million investment by Carbogen Amcis. The 9,500m² site features two fully automated production lines for liquid and lyophilized drug products, supporting a wide range of therapeutic areas, including highly potent compounds and advanced therapies such as antibody-drug conjugates. The setup is unique within Europe and fully compliant with the latest EU GMP Annex 1 standards for sterile medicinal products.

This new site complements Carbogen Amcis’ existing capabilities as a renowned API manufacturer. This news follows the announcement in February that current CEO, Pascal Villemagne will depart at the end of March.