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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...

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  • FDA
    FDA
  • GMP
    GMP
  • ISO
    ISO
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  • CA
  • 2015
    On CPHI since
  • 3
    Certificates
Company types
Contract Service
Manufacturer/Innovator
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Meet us at

CPHI North America 2024

Pennsylvania Convention Center, Philadelphia
07 May 2024 - 09 May 2024
View Exhibitor Profile

CPHI Milan 2024

Fiera Milano, Italy
08 Oct 2024 - 10 Oct 2024
View Exhibitor Profile

Products from Eurofins CDMO Alphora Inc (5)

  • Early Phase Support

    Product Early Phase Support

    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...
  • Phase 2 Support

    Product Phase 2 Support

    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...
  • Phase 3 or Commercial Support

    Product Phase 3 or Commercial Support

    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
    • Technolog...
  • API Development Services

    Product API Development Services

    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...
  • cGMP Manufacturing Services

    Product cGMP Manufacturing Services

    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)

  • Analytical Services 2021

    Brochure Analytical Services 2021

    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.