Shanghai Medicilon Inc.

  On April 29th, AnDiCon Bio (AnDiCon) announced that the Phase III clinical trial of the new influenza drug Madoxanavir tablets (ADC189), which cures Type A and Type B influenza in adults and adolescents, has reached its primary endpoint, demonstrating excellent safety and efficacy." Medicilon, as a partner of AnDiCon, provided  formulation research services  for the 'pediatric version' of the anti-influenza Class 1 Madoxanavir granules for influenza, assisting in its rapid advancement in preclinical research and development processes. This progress of Madoxanavir tablets not only validates its effectiveness and safety in treating influenza in adults and adolescents, but also indicates its enormous potential in the field of influenza treatment in children. About AnDiCon Bio The AnDiCon Bio Innovation Team, led by several academicians, focuses on the fields of respiratory anti-infection and pain.  The company has gathered a group of academic professionals and highly ...

Our CMC department focuses on establishing large-scale synthetic routes along with formulation development and quality control, our drug categories can be proprietary drugs or generic drugs. All studies are complied with ICH and SFDA guidelines. Feasibility study  Project planning Synthesis Establish synthesis “Freeze” the synthesis Establish large-scale Formulation Development Pre-formulation testing Formulation development Process optimization IVIV correlation Scale up Analytical Development Establish HPLC methods for API, impurities, isomers and drug product  Develop HPLC method for stability testing  Conduct HPLC method validation  Set API and drug product specifications Stability Study Perform stability study for API and drug product under ICH & SFDA guidelines Regulatory Submissions Prepare documentation for regulatory submissions Prepare supporting documentation and data package Our CMC exper...