CARBOGEN AMCIS Secures GMP Certification
CARBOGEN AMCIS 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.
CARBOGEN AMCIS has been granted a GMP certificate for the Saint-Beauzire facility, marking a significant milestone in the site's successful start-up. The certificate allows for the manufacture and release of clinical and commercial sterile drug products. The site received authorization from the ANSM to manufacture, test and release drug products from February 2023 and since then has been working under this authorization with the first clinical batch released in January 2024.
CARBOGEN AMCIS
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Country/Region:Switzerland
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On CPHI since:2015
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Certificates:1
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Employees:1000 - 4999
Other Content from CARBOGEN AMCIS (3)
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News CARBOGEN AMCIS Secures GMP Certification After Successful ANSM Inspection for its Aseptic Drug Product Manufacturing Site
CARBOGEN AMCIS 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 January, 20th to January, 24th, 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, France. -
News Swissmedic Inspection Success Highlights Excellence at CARBOGEN AMCIS Vionnaz Site
BUBENDORF, Switzerland (January 13, 2025) — Switzerland-based CARBOGEN AMCIS, a leading pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, is pleased to announce the successful completion of a Swissmedic inspection of its Vionnaz facility, reaffirming the site’s compliance with high regulatory standards.
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