Profile
We have extensive experience in supporting pharma and biotech companies in the successful development, manufacturing, and market launch of innovative drugs.
As a Dishman Carbogen Amcis Group member, we have a global presence with eight sites located in Switzerland, UK, France, the Netherlands, and China, employing over 1100 people worldwide.
Drug Substance CDMO
We excel in Drug Substance development, offering comprehensive support throughout the entire drug development lifecycle. Our capabilities include process development, optimization, and scalable manufacturing of Highly Potent (HiPo) active pharmaceutical ingredients (APIs). By prioritizing quality, safety, and efficiency, we help our clients streamline drug substance development, accelerating the path to market approval.
Our end-to-end drug substance CDMO services bridge the gap between clinical drug development and commercialization.
We offer a wide range of services including non-GMP supply, Clinical API supply, Commercial API supply, Stability studies and Reference standards. Our areas of expertise encompass HiPo APIs, ADCs and bioconjugation, chromatography, crystallization, integrated analytical services, flow chemistry, process criticality assessment and stability studies.
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Key Facts
- Over 40 years of experience in clinical API contract manufacturing
- Capabilities ranging from gram-scale production to several thousand kilograms
- Supporting projects from early clinical trials to commercial supply at scales up to 6,300 liters
- Six dedicated sites worldwide specializing in drug substance development and manufacturing
Customer Journey at CARBOGEN AMCIS – Episode 1: From Bench to Market
Drug Product CDMO
Our expertise in Drug Product development encompasses a wide range of pharmaceutical services. From formulation design to commercial-scale manufacturing, we specialize in efficiently bringing your Drug Product to market while ensuring full compliance with regulatory standards. Our highly skilled team at our state-of-the-art facility in Saint-Beauzire, France, ensures that your Drug Product is manufactured with precision and meets the highest quality standards.
At CARBOGEN AMCIS, we have the specialized skills and extensive experience required to develop and manufacture sterile drug products. Our expertise spans pharmaceutical sciences, microbiology, engineering, and process development, enabling us to deliver exceptional results.
We excel in drug formulation, sterilization methods, and aseptic pharmaceutical manufacturing. With a deep understanding of regulatory standards, we ensure the safe development and production of sterile Drug Products in full compliance with Good Manufacturing Practices (GMP) and other applicable guidelines.
We offer Drug Product development services, Industrial transfer, Clinical and commercial drug product manufacturing, Release testing and stability studies as well as QP services and regulatory support.
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Key Facts
- Over 20 years of expertise as a Drug Product CDMO
- Specializing in the development and manufacturing of sterile Drug Products
- Providing both liquid and lyophilized Drug Product solutions
- State-of-the-art facility designed for clinical and commercial supply, compliant with Annex 1 regulations
- Expertise in handling complex compounds, challenging formulations, and high-potency compounds
Customer Journey at CARBOGEN AMCIS – Episode 2: Advancing ADC and Drug Product Solutions
Cholesterol and Vitamin D Manufacturing
CARBOGEN AMCIS has a strong presence in the manufacturing, marketing, and distribution of Vitamin D analogs, Vitamin D2, cholesterol, and lanolin derivatives. These products are utilized across a wide range of industries, including pharmaceuticals, cosmetics, animal feed, food, shrimp farming, and industrial applications.
With over 70 years of experience, we have established ourselves as a trusted partner in the development, production, and global supply of these ingredients. Our production site in Veenendaal operates under a cGMP regime, holds EU GMP certification, and is classified as acceptable by the US FDA for API manufacturing.
Our comprehensive services include the production of Vitamin D analogs and Vitamin D2 products, cholesterol and lanolin derivatives, and Cosmetic GMP manufacturing.
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Key Facts
- Over 70 years of experience in Vitamin D and cholesterol manufacturing
- EU GMP-certified, cGMP-compliant, and US FDA-approved production site in Veenendaal
- Serving diverse industries, including pharmaceuticals, cosmetics, and food production
- Expertise in high-quality cholesterol, Vitamin D analogs, and lanolin derivatives
At CARBOGEN AMCIS, our flexible approach allows customers to benefit from tailored work packages that balance speed, cost, and quality. We also customize our communication and reporting processes to align with each customer’s specific requirements and documentation standards. This commitment to adaptability and excellence ensures efficient project delivery and consistently high-quality outcomes.