CARBOGEN AMCIS has successfully completed the first inspection by the French regulatory authority, ANSM (Agence nationale de sécurité du médicament et des produits de santé), at its state-of-the-art sterile drug product manufacturing site in Saint-Beauzire, France.

The inspection, conducted from 20-24 January, follows the site’s opening in February 2023. This is the first inspection of a routine process by ANSM to ensure compliance with Good Manufacturing Practices (GMP). 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. 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,” said Angie Stevens, Vice President, Drug Product Business Unit.

Opened in early 2023, the Saint-Beauzire facility represents a major investment by CARBOGEN AMCIS (60 million euros). 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 flexible and versatile setup is unique within Europe and fully compliant with the latest EU GMP Annex 1 standards for sterile medicinal products.

With over 15 years of expertise in developing injectable and liquid pharmaceutical forms, CARBOGEN AMCIS’ Saint-Beauzire site provides tailored solutions for pre-clinical and clinical trials and small-scale commercial manufacturing, employing approximately 130 highly skilled professionals.

“The successful ANSM inspection reaffirms CARBOGEN AMCIS as a reliable partner in the drug product manufacturing market. With our extensive expertise and a state-of-the-art GMP-certified facility, we are well-positioned to support customers’ drug product projects with excellence,” said Helen Caddy-Leach, Head of Business Development, Drug Product.

This new site complements CARBOGEN AMCIS’ existing capabilities as a renowned API manufacturer. “Having a cutting-edge facility dedicated to developing and manufacturing sterile drug products, including to a commercial scale, strengthens our ability to offer comprehensive end-to-end services, from drug substance to drug product. This integrated approach is a significant advantage in today’s competitive pharmaceutical landscape and provides added value for our clients,” said Stephan Fritschi, CEO of CARBOGEN AMCIS.