Carbogen AMCIS obtains GMP certification for its sterile drug manufacturing site in Saint-Beauzire.

Carbogen AMCIS, a leading company in the development and manufacturing of active pharmaceutical ingredients and pharmaceutical products, has announced the successful completion of the first inspection by the French National Agency for Medicines and Health Products Safety (ANSM) at its sterile drug manufacturing site in Saint-Beauzire.

This inspection, conducted in January 2025, follows the site’s opening authorization granted in February 2023. As a result, Carbogen AMCIS has been awarded a GMP certificate for its Saint-Beauzire site, marking a significant milestone in the facility’s ramp-up phases. This certificate covers the manufacturing, analysis, and release of clinical and commercial sterile drugs.

Thanks to the opening authorization obtained in February 2023, the site began its activities in 2023 and released its first batch in January 2024.

A State-of-the-Art Facility

Inaugurated in early 2023, the Saint-Beauzire site represents a major investment by Carbogen AMCIS (60 million euros), highlighting the company’s commitment to strengthening its sterile drug manufacturing capabilities. The 9,500 m² 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 (ADCs). Its flexible and versatile configuration is unique in 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, the Saint-Beauzire facility offers customized solutions for preclinical trials, clinical trials, and small to medium-scale commercial manufacturing. The site also creates significant employment opportunities, with approximately 130 highly skilled professionals.