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Formulation & GMP Production of Aseptic Parenterals

Our wholly-owned French subsidiary, CARBOGEN AMCIS SAS, located in Riom, France, focuses on the development and manufacturing of formulation dosages, aseptic filling, and lyophilization of small-molecule APIs, highly-potent APIs and biologics.

With over 10 years of experience in the fast supply of clinical trials batches, CARBOGEN AMCIS SAS offers comprehensive services in formulation and for aseptic drug products for a wide range of products, including oncology and metabolic disorders therapeutics. Our flagship track record speaks for itself: since 2000, CARBOGEN AMCIS SAS has manufactured over 300 GMP batches of APIs, such as highly potents, cytotoxics, proteins, mAbs, peptides, enzyme inhibitors and antibiotics (non-ß-lactam) and vaccines (non-life).

CARBOGEN AMCIS SAS operates to European Good Manufacturing Practice (GMP) and was successfully inspected by the French Health Agency (Agence Française de Sécurité Sanitaire des Produits de Santé - AFSSAPS) over the past 10 years. Containment within the manufacturing facility is ensured through a "protection cascade" of barrier isolation technology and of flexible and disposable manufacturing equipment. This allows the safe production of injectables of the highest occupational exposure band which includes, for example, cytostatics and cytotoxics.





Events
CPhI Japan 2012

European Complience Academy Event on High Potency


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News
13 February 2012
CARBOGEN AMCIS AG Announces Successful FDA Audit

16 January 2012
CARBOGEN AMCIS Acquires Creapharm Parenterals

19 October 2011
CARBOGEN AMCIS and Polymun Scientifc GmbH Sign Collaboration Agreement


Case Studies

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