DRUG PRODUCT DEVELOPMENT AND MANUFACTURING

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Target
  • Compared with the dissolution curve of the reference formulation f2>60
  • Meet the drug product requirements in pharmacopeias
  • Meet the specs of imported drugs
  • Preparation of CTD format documents
Technical services
  • Preformulation and formulation study
  • Formulation process development and manufacturing
  • Conformity evaluation of the quality of generic solid drug products
Technical package
  • HPLC method development and validation
  • Characterization of API and RLD
  • Dissolution method development and validation
  • Compatibility study of API and excipients
  • Stability study
  • Key parameters operation interval of small and pilot scales
  • Formulation process SOP