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Eurofins CDMO Alphora Inc
About Eurofins CDMO Alphora Inc
Eurofins CDMO Alphora Inc., operating as part of Eurofins CDMO, is a leading provider of Active Pharmaceutical Ingredient (API) and Drug Product (DP) development and manufacturing services for complex small molecules, including highly potent compounds.
As an FDA-approved contract development and manufacturing organization, we specialize in process chemistry, cGMP & non-cGMP scale-up and analytical method development. Through the integration of synthetic Process R&D, Solid State R&D, Pre-Formulation and Formulation Development, we offer a full suite of drug development services and m...
2015On CPHI since
CPHI North America 2023
Pennsylvania Convention Center, Philadelphia
CPHI Barcelona 2023
Fira Barcelona Gran Via, Spain
Products from Eurofins CDMO Alphora Inc (5)
From the lab to the plant:• Development of new, scalable API route options
• Process safety and hazards assessment
• cGMP starting material assessment& establishment of regulatory concept
• Starting material & other raw materials sourcing and development
• Polymorph screening & salt...
Setting the stage for the commercial process:• Route or step rebuild
• Process optimization &demonstration
• Impurities assessment & synthesis
• Full structure characterization &elucidation
• Analytical method development &qualification
• Stress studies & ICH stability st...
Taking the molecule to market• Fate & purge studies
• Impurities marker synthesis &qualification
• Design of experiments
• Critical process parameters studies
• Preparation for, and execution ofprocess validation
• Continuing CMC support during &after market launch
Eurofins CDMO is an FDA-approved contract development and manufacturing organization (CDMO) focused on process chemistry, cGMP scale-up and analytical method development for complex, small molecule APIs, including highly potent molecules. Our talented team of Process Research, Analytical, Technology Transf...
Our Operations team has extensive experience in cGMP clinical drug product manufacturing. Our state-of-the-art facilities and cGMP compliant systems are specifically designed for quick-to-clinic operations. Eurofins CDMO’s team of Engineers, Technology Transfer specialists, and Scientists specialize in pro...
Eurofins CDMO Alphora Inc Resources (1)
Eurofins CDMO offers analytical services as part of API development as well as stand-alone analytical testing services for projects at various stages in the drug life cycle (pre-clinical to late phase). Our analytical scientists specialize in the development of analytical methods and phase appropriate specifications to ensure control of the synthetic process and quality of API throughout the program.
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