Indena: Semisynthesis Paclitaxel Granted CEP

The purpose of the CEP certification procedure is to provide proof that the quality of the substances used in human and veterinary medicines are suitably controlled by the relevant monographs of the European Pharmacopoeia.

16/07/09 The European Directorate for the Quality of Medicines (EDQM) has recently granted Indena, a leading company dedicated to the identification, development and production of active principles derived from plants, a “Certificate of Suitability of the European Pharmacopoeia (CEP)” for Paclitaxel from semisynthesis, obtained through its own patented process. This CEP is the latest granted to Indena by the EDQM regarding Paclitaxel as the company already holds CEPs for naturally sourced Paclitaxel.

EDQM is the body responsible for granting CEPs to Active Pharmaceutical Ingredients which are covered by European Pharmacopoeia monographs. The purpose of the CEP certification procedure is to provide proof that the quality of the substances used in human and veterinary medicines are suitably controlled by the relevant monographs of the European Pharmacopoeia. These certificates are recognised by all European Union members and other countries including Australia, Canada and Switzerland.

Commenting on the news, Ernesto Marco Martinelli, Group Quality Assurance Director, said: “Our customers can save valuable time and resources thanks to the CEP which is widely accepted as a recognition of quality. In fact, by avoiding the need to submit process and quality control documentation for the active substance covered by the CEP, the time-to-market is shortened, resulting in cost savings whilst high product quality is still ensured. In addition, any changes in the process are managed directly by the CEP holder (Indena) together with the EDQM which also saves time for the final customer”.

Indena is routinely inspected by the Italian Medicines Agency (AIFA) for compliance with ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, adopted in Europe, USA and Japan) and GMP Certificates are available. The outcome of FDA inspections of all the company’s Paclitaxel varieties has proved positive.

Indena Semisynthetic Paclitaxel is obtained using a specific process patented by Indena based on the 10-Deacetylbaccatin, a molecule extracted from yew trees (Taxus baccata) cultivated in the company’s own plantations.