The CEP procedure concludes suitability of monographs to control the chemical purity and quality for any substance covered by a European Pharmacopoeia monograph.
The procedure even 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.
Phyton general manager Marc Iacobucci said the company’s 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," Iacobucci added.