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Service Introduction

Sinopep's elite CMC team offers end-to-end support, steering projects from conception to market launch seamlessly.  With tailored solutions, industry-leading expertise, and a commitment to excellence, we ensure meticulous guidance and regulatory compliance, accelerating your product's journey to success.

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Small Molecules

Excellence and Compliance: Seamless interaction between Process R&D and Manufacturing teams

Our process R&D team provides full end-to-end API development and analytical services ranging from synthetic route design, scouting, and process optimization for RSMs and APIs.  It enables our partners cost effective and un-interrupted API supplies during all phases of drug development as well as commercial launch with unmatched speed and efficiency.

The small molecule Process R&D center located in Hangzhou and led by a group of industrial veterans educated and previously worked in well-known pharmaceutical and biotech companies overseas in both drug discovery and development fields.  With our rich API process development and manufacturing experience accumulated from large number of development projects, combined with the valuable input from our industrial experts, our small molecule CMC team ensures the abilities to help our clients to solve challenging technical issues during towards scaling up the synthesis of highly complex molecules under full compliance.  We are a true one-stop solution provider for our partners throughout the full lifecycle of their drug candidates.

Synthetic Macromolecules

  • Project Code
  • Project Typr
  • Classification
  • Status
  • APC269
    CDMO
    RSM, Antiviral
    Commerial scale
  • APC274
    CDMO
    RSM, Antiviral
    Commerial scale
  • APC295
    CDMO
    API, New drug
    CRL
  • APC321
    CDMO
    RSM, New drug
    Pilot scale
  • APC345
    CDMO
    RSM, New drug
    Pilot scale
  • APC365
    CDMO
    API, Generic drug
    ANDA

Production Equipment

    • Agilent 1260 HPLC / Themo HPLC / Agilent UPLC 1290*29

    • Agilent 7820 GC / Agilent HSGC 8890+7697A*7

    • Agilent 1260 LC-MS*3

    • Agilent GC-MS 8890+5977B*1

    • Agilent 7850 ICP-MS*1

    • QTOF-MS*1

    • Mastersizer 3000*1

    • KF*4

    • Electron microscope*1

    • Automatic Melting Point Meter*1

    • Potentiometric titrator*1

    • Rapid Water Drier*1

    • Drug Stability Test Chamber*2

    • High Light Stability Test Chamber for Drugs*1

    • Thermogravimetric Analysis (TGA)*1

    • UV-Vis Spectrophotometer*1

    • Milli-Q IQ7000*2

    • Ultra-Microbalances*4

    • Differential scanning calorimeter: Mettler DSC3*1

    • Automatic reaction calorimeter: Mettler RC1*1

    • Accelerating rate calorimeter: THT ES-ARC*1