Quality

Phyton Biotech is committed to compliance with all applicable regulations and quality standards in the development, manufacture, and supply of GMP active pharmaceutical ingredients and starting materials.

We continuously strive to improve all of our systems and processes in order to enhance the quality of our products. At Phyton we endeavor to not only meet the changing needs of our customers, but to exceed customer expectations in all aspects of our business.

Quality Control and Assurance
Phyton APIs are supported by in-house quality laboratories, robust quality systems, and a team of highly skilled analysts in our German and Canadian manufacturing facilities. From starting material through to finished API, our QC and QA teams ensure our APIs are manufactured and tested under strict GMP and meet USP/EP/JP compendia requirements.
Compliance
Phyton’s manufacturing facilities comply with international GMP requirements. Our facilities have been successfully inspected by multiple regulatory agencies, including:

  • European Health Authorities
    • EDQM
    • EMA Health Authorities
    • Romania National Agency for Medicines and Medical Devices
    • State Social Services Agency Schleswig-Holstein
  • US FDA
  • Australia TGA
  • Korea FDA
Click here to access our Regulatory section.