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ChemPartner’s formulation group specializes in the development of novel solid and liquid dosage forms. Liquid dosage forms such as oral solutions, suspensions, and injectables have become the focus for pre-clinical safety evaluation in the industry. We are proud to provide these services, along with oral solid dosage formulation development and manufacturing of clinical trial material, at our state-of-the-art Zhang Jiang facility. 

Our formulation service provides our clients with essential support for pivotal GLP studies, subsequent clinical trials, and later stage development in a timely, cost-effective manner. We have the capability and expertise to manufacture drug products suitable for Chinese NMPA, US FDA, and European Union EMA clinical studies.

 

Preclinical Formulation Development

  • IV/oral liquid formulations for PK, pharmacology, and non-GLP tox studies
  • Integration with internal drug discovery capabilities in medicinal chemistry, biology, DMPK, and toxicology
  • Use up-to-date technologies to optimize preclinical formulations to support drug discovery programs

 

Technologies for Poorly Soluble Compounds

  • SEDDS formulation
  • Nanosuspension (wet media milling)
  • Emulsion, microemulsion, lipid based complex, and micelle formulation
  • Solid Dispersions: micro-crystalline or amorphous form with carrier matrix
  • Solubilizing Agents: cyclodextrins, surfactants, polar organic solvents

 

Early Phase Clinical Formulation

  • Powder in Capsule (PIC)
  • Powder in Bottle (PIB)
  • Tablet
  • Liquid formulation

 

Oral Solid Technologies

  • Wet granulation (high shear, fluid bed, extrusion spheronization)
  • Dry granulation (roller compaction)
  • Nanosizing in solid dosage form
  • Tableting, hard shell and soft-gel capsulation
  • 0.1-20 kg capacity (for SFDA studies and FDA studies)

Headquarters

1F & 3F, Block A
2829 JinKe Road
Zhangjiang Hi-Tech Park
PuDong New Area
Shanghai China, 201203

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Contact Us

China: +86 21 5132 0088
US: +1 650 419 9974
Europe: +45 4586 9000
Japan: +81 03 5403 6975

contact@chempartner.com