Avanefil Development and Testing

Vanton established and validated the stability testing methods for Avanafil commercial product known as Stendra® (in US) and Spedra® (in Europe). The work includes:

  • ICH GMP storage
  • Set up stability program including QA/QC/Management
  • Physical description/Assay/dissolution/Purity
  • Hardness/Water Content/Microbial (USP<61>)
  • Transfer methods to an European testing lab for EU market
  • Develop an ODT dosage form
spedra avanafil

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