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CDMO/CMO Business
CDMO / CMO

Based on our professional team and cGMP facilities that meet regulatory requirements in many locations, we can provide customers with customized drug substance manufacturing focused on quality, innovation and flexibility, and we can provide the following services for your projects from early stage development to scale-up and commercial production：

Drug substance process development
01
  • Process route design, development and optimization
  • Total quality study based on QbD
  • Process validation
  • Management of product life cycle
  • Process safety assessment
Intermediate, drug substance manufacture
02
  • NON-CGMP/CGMP pilot and commercial production
  • Micronization manufacturing of sterile/non-sterile drug substance
  • Safety control of production operation
CMC registration support
03
  • Synchronous evaluation and planning of key CMC R&D activities
  • Compliance guidance and support of key CMC manufacturing activities
  • Preparation, writing and technical review of application dossiers
  • ANDA registration of USA, EU, Japan and China
  • Submission of dossiers and good communication with authorities
Quality research and analytical R&D
04
  • Analytical method development and validation
  • Standardization of reference substance and product release
  • Microbiological, sterility and endotoxin studies
  • Stability study
  • Lifecycle management technical support of analytical method