Manufacturing

Manufacturing

Our primary manufacturing facilities are located in the Fengxian Industrial Park in the greater Shanghai area. The facilities have been fully GMP operational since 2011. The highly experienced technical and plant operation teams, including project management and...
Manufacturing

CMC CTD Support

Registration starting material strategy Impurity management – fate and linkage Potential genotoxic impurity management API manufacturing and analytical information in formats appropriate for inclusion in regulatory filings (CTD Section 3.2.S.1 through 3.2.S.7)  Drug...
Manufacturing

ICH Stability Studies

Stability Chamber (IQ/OQ/PQ, annual calibration): temperature, humidity, light Stress testing, accelerated, intermediate, long-term, etc. Stability sample management Stability testing: chemical properties, physical properties   Stability Management Development of...
Manufacturing

Formulation Development

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...
Manufacturing

Pre-Formulation Development

Pre-Formulation Support: Salt selection screeningPolymorph screeningThermal propertiesSolubility profilingHygroscopicityMicroscopy and morphologyCrystallinity evaluationFlowabilityParticle size and distribution measurementBulk and tap densitiesLog P/Log D and pKa...