Phyton Biotech, a global supplier of high quality 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 for its paclitaxel active pharmaceutical ingredient (API) produced from plant cell fermentation. Phyton’s CEP application was filed in October 2011.
The CEP procedure assesses and concludes suitability of monographs to control the chemical purity and quality for any substance covered by a European Pharmacopoeia monograph; and checks compliance at the manufacturing and/or distribution site(s) covered by CEPs with both Good Manufacturing Practices for medicinal products and the information submitted in the application. The CEP, in part, facilitates and simplifies exchanges between regulators and industry to ensure the quality of substances used in the production of pharmaceutical products and that such substances comply with the European Pharmacopoeia; and facilitates the management of marketing authorization applications for medicinal products.
Comments General Manager, Marc Iacobucci: “Phyton has invested heavily to become the leading producer of high quality paclitaxel in the world. Our tremendous capacity to produce paclitaxel from plant cell fermentation eliminates reliance on yew tree plantations and their inherent problems related to the environment, sustainability, reliability, and consistent quality. This milestone is especially important to Phyton as the CEP is widely recognized as certification of API quality; and makes it much easier for our customers to gain market authorization to use our API both in highly regulated markets and those emerging markets that are placing more emphasis on product quality.”
Phyton Biotech, a DFB Pharmaceuticals, Inc. company, is a global supplier of high quality paclitaxel and docetaxel API. The company has development and manufacturing facilities near Hamburg, Germany and Vancouver, Canada. One of the largest producers of paclitaxel and docetaxel in the world, Phyton has been inspected by EDQM, EMA, FDA, KFDA, and TGA. Phyton also offers development services to its customers via plant cell fermentation (PCF™), chemical semi-synthesis, and purification for taxanes, secondary metabolites, recombinant proteins, and other active ingredients.