Quality

The Regulatory Affairs team at Phyton Biotech compiles high quality registration documents. They are involved in all aspects of the registration process in order to ensure complete and successful registrations in several countries. Phyton holds the following registrations:

Docetaxel

  • EU CEP, R0-2012-105
  • US DMF, #24675
  • Canada DMF, #2013-131
  • Japan DMF, #224MF10168
  • Korea DMF, Filed
  • China DMF, JXHS1300080
Paclitaxel from Fermentation

  • EU CEP, R0-2011-324
  • US DMF, #25525
  • Japan DMF, #224MF10111
  • Korea DMF, #20130614-68-A-278-15
  • Taiwan DMF, (07)0537
  • China DMF, JXHS1300005

Regulatory Compliance

Phyton’s manufacturing facilities comply with international GMP requirements. These facilities have been successfully inspected by multiple regulatory agencies, including:

  • EDQM
    • EMA Health Authorities
    • Romania National Agency for Medicines and Medical Devices
    • State Social Services Agency Schleswig-Holstein
  • US FDA
  • Australia TGA
  • Korea FDA