2Y-Chem, Ltd : CGMP contract manufacturer, outstanding process R&D skills, extensive analytical method development and validation experience, Western regulatory expertise and consulting.
Ausun : Experienced technical team specializing in Grignard reactions, low temperature conditions, halogenations (including fluorine) and oxidations, many success on challenging chemistry.
Minsheng Pharma : New FDA approved cGMP facility for general chemistry with large capacity and reliable supply.
Changzhou Kony : Medium-sized general chemistry cGMP facility, specializing in anti-viral drugs and carbohydrate derivatives (e.g., 1,3,5-Tri-O-benzoyl-2-deoxy-2-fluoroarabinofuranose, CAS# 97614-43-2).
Jiahua Chemical : New large factory for general chemistry, specialized for large volume non-GMP production with very good economy, high efficiency and reliable supply.
Suzhou Lixin : Chinese GMP-approved medium-sized facility for general chemistry, equipped with good hydrogenation facilities.
Lianhe Pharma : New EU-approved cGMP facilities for general chemistry; young and energetic team with wide expertise.
Chemzam : Very responsive and efficient R&D and pilot facility utilizing general chemical processes, led by capable and reliable technical leaders.
Our requirements on the suppliers
- Commercial operation: reliable with effective communication
- Technical competence:
- Multi-functional middle stage test workshop and production workshop which is capable of manufacturing from kilos to tonners;
- High capability in making pilot-scale production;
- With complete analytical and test condition;
- With certain chemical synthesis technology and production equipment which can accomplish the procedure of hydrogenation, low temperature reaction, water-free anaerobic reaction, liquid distillation and other chemical reactions of fluorine, carbohydrate, boron, Heterocyclic, photochemistry, Amino acid protection reagent;
- Distinctive in making pilot-scale manufacture of fermented product
- Management system:
- The quality management system should be in compliance with the ISO standard and the entire production process should be controllable and traceable;
- The cGMP management system should be in compliance with the ICH standard and should be capable of taking customerized cGMP project.