Generic Drug Process Study & Filing

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• We provide the following drug master file (DMF) services for an API for generic drug manufacturing processes:
  Synthetic routes designRoute selectionAPI crystal form confirmationProcess optimization Quality research cGMP-based verification for lab-scale tests and pilot scale tests Stability tests of APIs Development and verification of API analysis methods Writing and Arrangement of API filing materials (Medicilon can provide all drug master files regarding API and in CTD format) IND Filing services

• Development of Generic Drug API:
  Approval of product project: Project Investigation, evaluation and consultationResearch on reference preparation:  Selection, filing and purchase of reference preparationsPharmaceutical research: Research on API key quality attributesQuality comparisons with reference preparationsComparative researches on impurity profile between API and reference preparationsResearches on the quality of synthetic process development, optimization, modification and process verification of APIResearches of variables of formulation and preparation process parameters to ensure the quality consistency between generic drugs and reference preparationsStability reviews and method verificationsTechnology transfers
  By continuously optimizing processes to obtain a mature and easy-to-industrialize process route, we establish a database for key process parameters. According to the characteristics of process routes, we establish a complete impurity profile of starting materials, intermediates, and raw materials, so that the prepared API can meet generic drug requirements , thus enabling industrial production.

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