CMC

CMC
Product Description

Services include contract research and development and analysis for the purpose and regulatory dossier development as well as the corresponding registration   applications.

Production process study

Route investigation and determination Laboratory & pilot level

Key starting materials and intermediates contol

Process transfer

Characterization

API structure identification

Impurity synthesis, isolation, structure identification (NMR/LC-MS/MS/IR/UV)

Quality research

Analysis method development, validation,transfer,re-validation

Specifications development and establishment

Working standard qualification

Stability studies

Influencing factors stability studies,accelerated stability

Studies and long-terms stability studies

Registration Applications

Local drug registration applications

Draft DMF in CTD format with CMC dossier submisssions

Provide consultation on the Chinese registration regulations and assistance of on-site inspections

Read more Show less

Sphinx Scientific Laboratory (TianJin) CO.,LTD.

  • Country/Region:
    China
  • On CPHI since:
    2015
Company types
CMO/CDMO
Manufacturer/Innovator
View company profile
Categories
more categories Show less
Specifications
  • Selling Points
    Experienced Technicians; Green Product; Prompt Delivery; Quality Service
  • Supplied from
    China
  • Measured In
    kilogram; Ton
More specifications Fewer specifications
Sales Markets
Show more Show less

Sphinx Scientific Laboratory (TianJin) CO.,LTD.

  • Country/Region:
    China
  • On CPHI since:
    2015
Company types
CMO/CDMO
Manufacturer/Innovator
View company profile

More Products from Sphinx Scientific Laboratory (TianJin) CO.,LTD. (2)

  • Chemical Synthesis

    Product Chemical Synthesis

    Contract synthesis from Kilos to Tons

    Chemical synthesis of APIs and advance intermediates

    Development and process optimization of the lead compounds

    High pressure catalysis/Low temperature reaction/High temperature reaction

    Fluorination reaction/Asymmetr...
  • Research and Development

    Product Research and Development

    Route screening and optimizationRapid pilot production to meet early drug development needsCommercial production route investigation screen and optimizeProduction process parameters detemination

Sphinx Scientific Laboratory (TianJin) CO.,LTD. resources (1)

  • Sphinx_Non-GMP Plant

    Video Sphinx_Non-GMP Plant

    Glass-lined Reactor: 500L-3000L

    Stainless Steel Reactor: 2000L (150~260℃)


    Autoclave Reactor: 1000L/2000L

    Fluorination Reactor: 1000L/2000L

    Titanium Steel Reactor: 500L/1500L(-80℃)

    Continuous Reactor: 1000L/DAY

    Ozonator: 1KG/H

    Pressure Filter: 200L/500L

    Chromatographic Column: ø400X5000/ ø600X5000





    2017-06-06