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    Zhejiang Dongjian Pharmaceutical Co., Ltd?
     

    CDMO Service

    Assessment phase
     
    Laboratory Development
     
    Laboratory Validation

    Patent research 


    Literature assessment 


    Proposals of potential synthesis routes

     

    IP verification of proposed synthesis routes 


    Raw materials/intermediates market availability evaluation 


    Cost calculation?

     
    Batch Record&Manufacturing

    Laboratory verification of synthesis routes 


    Selection of synthesis route for optimization or based on IP assessment and cost calculation 


    Development of purification method 


    Preliminary analytical methods development

    Optimization of chosen synthesis route- technology development 


    Development of analytical methods for product 


    Process laboratory validation 


    Validation of analytical methods 


    Transfer of analytical methods to Quality Control Laboratory 


    Cost calculation and IP assessment

    Transfer to Manufactory 


    Scaling up in Pilot Plant 


    Scaling up in factory 


    Documenting in the batch production records, the facility log, or other documentation system 


    IP control and project confidentiality.

    Meeting customer expectations

    ?

    ?DongjianPharma brings many years of experience in the Small Molecule (Including intermediates)development and manufacturing market, where we have considerable experience with a repertoire of chemical reactions and transformations, including but not limited to:

    Chemical reactions and transformations

    >> Hydrogenations 

    >> Oxidations 

    >> Cryogenics 

    >> Friedal-Crafts 

    >> Organometallics 

    >> Amination 

    ?>> Cyanation

    >> Carbonylation 

    >> Diels-Alder 

    >> Acylation 

    >> Phosphorylation 

    >> Bio-Catalysis 

    >> Chiral Synthesis 

    ?>> Halogenation reaction

    >>Being active Project Team Member 

    >>Reliability

    >>Adequate experience and resource availability

    >>Equipped facility

    >>ICH guidelines Q11 (Development and Manufacture of Drug Substances) and Q9 (Quality Risk Management) compliance 

    >>Good Laboratory Practice (GLP) 

    >>Good Manufacturing Practice (GMP) 

    ?>>Strictest compliance with Intellectual Property Management
    ?
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