Phyton Biotech, a global supplier of paclitaxel and docetaxel API, has been granted a Certificate of suitability to European Pharmacopeia (CEP) by the European Directorate for the Quality of Medicines and HealthCare (EDQM) for its docetaxel anhydrous API. Phyton is the first North America- or Europe-based contract API supplier to be granted a CEP for docetaxel. Phyton’s docetaxel API is not subject to the current shortage of 10-deacetylbaccatin (10-DAB) starting material because it uses paclitaxel from its own plant cell fermentation facility.
Chief technology officer and vice president of business development, Roland Franke, Ph.D., said, “Virtually every other docetaxel API supplier in the world uses 10-DAB as their docetaxel starting material. Unfortunately, docetaxel API is now in short supply because we are in a periodic shortage of 10-DAB, which is derived from yew tree plantations that are subject to climate, environmental, and harvesting issues. Our docetaxel API uses paclitaxel as its starting material, and the paclitaxel we use is via plant cell fermentation that is produced at our own facility near Hamburg, Germany.”