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CMC

Committed to the development and innovation of first-class drugs

The Pharmaceutical R & D Department is located in Beijing Zhongke Industrial Park, with a 10000 square meter R & D laboratory, equipped with production and testing equipment which can support the stage from laboratory to pilot test certificate. The main process research equipment includes synthetic reactor, rotary evaporator, preparation chromatography, wet/dry granulator, multifunctional fluidized bed, capsule filling machine, (enteric coated tablets) coating machine, extrusion and spheronization machine, various types of tablet press, capsule filter, micro jet nano homogenizer, ampoule melting and sealing machine, damp heat sterilization cabinet, sterile isolator, blow filling and sealing (BFS) all-in-one machine, freeze dryer, liquid distribution tank, respiratory simulator, pharmaceutical multi-stage impactor (NGI) and other equipment; The analysis and detection equipment includes more than 200 HPLC, more than 50 dissolution instruments and more than 100 large-scale precision instruments such as UPLC, GC / GC-MS, LC-MS, ICP-MS and TGA.

 

 

  • 20Years

    Pharmacy research for drug registration has nearly 20 years of research and development experience

  • 400Projects

    Completed more than 400 drugs R&D projects

  • 200Projects

    Undertaken nearly 200 consistency evaluation projects

The scope of services includes:

  • 01
    Research on the synthesis process of API
  • 02
    Research on formulation and technology
  • 03
    Drug quality research and method verification
  • 04
    Impurity customization
  • 05
    Substance detection
  • 06
    Research on special impurities
  • 06
    Compatibility Study
  • 07
    Registration risk assessment and application data writing

Pharmaceutical R&D project management mode:

①    Conference Management Center: according to the characteristics of the project, experts from inside and outside of the company will set up an expert group to check each key node of the project based on the guiding principles and the company's standards, strengthen the whole process control of the project to ensure the smooth application of the project,strengthen the whole process control of the project to ensure the smooth application of the project.
②    Technical Committee: Organize and solve technical problems. In response to important technical problems encountered in the project development process, the technical committee organized a team of experts from the company to provide technical support to solve technical problems and ensure the smooth development of the project.
③    QA:In the whole process of project research and development, conduct normative inspection of the site and documents to ensure the reliability and standardization of experimental data and the high-quality pass of on-site inspections.