CARBOGEN AMCIS Secures GMP Certification After Successful ANSM Inspection for its Aseptic Drug Product Manufacturing Site

/EIN News/ -- BUBENDORF, Switzerland, March 24, 2025 (GLOBE NEWSWIRE) -- Switzerland-based CARBOGEN AMCIS, a leading pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, is pleased to announce the successful completion of 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,” 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.”

A State-of-the-Art Facility
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,” said Helen Caddy-Leach, Head of Business Development, Drug Product. “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.”

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,” said Stephan Fritschi, CEO of CARBOGEN AMCIS. “This integrated approach is a significant advantage in today’s competitive pharmaceutical landscape and provides added value for our clients.”

CARBOGEN AMCIS Secures GMP Certification

CARBOGEN AMCIS (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources. CARBOGEN AMCIS is a wholly owned subsidiary of Dishman Carbogen Amcis Limited., Ahmedabad, India.

For further information contact:
Denise Neufeld +41 79 213 06 60
Denise.Neufeld@carbogen-amcis.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/e6dcee43-4dad-4d7c-a808-d12f232019de