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