Sterile Drug Product services

The complete integration of analytical sciences into the process of API development is fundamentally understood at CARBOGEN AMCIS. Our scientists, technique ranges, systems (including a fully validated LIMS) and procedures facilitate a full understanding of the unique characteristics of the complex molecul...

CARBOGEN AMCIS has a DNA in API development, stretching back over 30 years. Our API development teams are selected for their passion for science and experience in the application of phase-appropriate efforts to solve challenging chemistry issues. From taking a promising molecule from our clients' medicinal...

CARBOGEN AMCIS has a track record, extending over 25 years, helping our customers transition their molecules from process development through validation and ultimately into commercial status. A range of services backed up with fully integrated support functions has been developed to facilitate and smooth t...

CARBOGEN AMCIS has developed a comprehensive range of services for the formulation of New Molecular Entities (NMEs) and the reformulation of existing drugs. With a specialization in developing sterile and pyrogen-free parenteral formulations for preclinical and clinical trials (phases I, II and III), CARBO...

CARBOGEN AMCIS has state of the art facilities and controls to handle both drug substance and drug product of the highest potency and toxicity, under cGMP. Our dedicated containment facilities use a containment methodology, utilizing barrier isolation technology and Rapid Transfer Ports (RTPs), combined wi...

CARBOGEN AMCIS provides comprehensive Drug Substance services, offering expertise in process development, scale-up, and manufacturing of active pharmaceutical ingredients (APIs). With state-of-the-art facilities, the company specializes in high-potency compounds, including cytotoxics, and delivers solu...

Specialty manufacturing and services provided by CDMOs address the diverse needs of customers in various therapeutic, nutraceutical and dietary supplement areas, as well as in the pharma, personal care, and cosmetics industries.

With over 70 years of experience, CARBOGEN AMCIS Veenendaal...

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.

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.

Switzerland-based CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) and drug products manufacturing company, announced today new expansion plans in Switzerland and France.

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Drug development to Commercialization services for pharmaceutical and biopharmaceutical industries at all stages of drug development

Your CDMO from Drug Substance to Drug Product