Our comprehensive drug substance and API CDMO services bridge clinical drug development and commercialization
Non-GMP Services and Supply
Non-GMP services are essential for developing and optimizing processes towards new drug candidates in research, preclinical studies, and clinical trials.
CARBOGEN AMCIS provides a variety of non-GMP manufacturing services and supplies to meet biopharmaceutical and pharmaceutical industry needs. Our modern facilities can handle many custom development and manufacturing projects. These include modern kilo labs, process development labs, and manufacturing facilities. As a leading active pharmaceutical ingredient manufacturer, we can develop starting materials, intermediates, fine chemicals, cosmetic ingredients, and specialty chemicals.
Clinical API Services & Supply
By combining knowledge, accuracy, and regulatory understanding, CARBOGEN AMCIS sets the benchmark for clinical API development and manufacturing services.
We are able to provide in-house solutions that go beyond basic development to include regulatory consulting, through stability studies, full analytical support including method validation, with a focus on upscaling clinical drug manufacturing processes. Our services are designed to facilitate a seamless transition between the various phases of drug substance development and manufacturing, minimizing risk and maximizing results.
Commercial API Services and Supply
Commercial API manufacturing involves developing, manufacturing, and supplying the compounds used in pharmaceutical products.
Since 1996, CARBOGEN AMCIS has led commercial API manufacturing. The company’s flawless recall-free record shows its quality and safety commitment. With over 30 exclusiveCARBOGEN AMCIS has met the strict requirements and inspections of major markets like the US, EU, Japan, Korea, Australia, and Brazil. CARBOGEN AMCIS is also supplying high-potency commercial products, for oral and parenteral use.
Stability Studies and Reference Standards Services
CARBOGEN AMCIS provides stability studies and reference standard services to meet International Conference on Harmonization (ICH) guidelines.
Contract R&D and analytical chemistry for APIs, including Highly Potent APIs (HPAPIs), are our specialties. We work in close partnership with our customers to gain a thorough understanding of their new chemical entities (NCEs). This synergy allows us to tailor our services to not only meet but exceed expectations, significantly reducing the time, cost, and risk associated with developing innovative pharmaceutical products.
Expertise Areas
To provide our customers with full flexibility, we’ve developed a specialized portfolio of services. Leveraging more than 40 years of experience, we focus on high-potency APIs, custom ADCs, and bioconjugation projects in cGMP-compliant facilities.
Our team provides tailored solutions in chromatography, crystallization and stability studies, complemented by comprehensive analytical services to improve drug development and manufacturing efficiency. We ensure that our products meet global standards for quality, safety, and efficacy. Using techniques such as flow chemistry, we efficiently address scale-up challenges and hazardous reagent management, facilitating rapid and safe market access for novel drug substances.
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