Indena receives CEP certification for Paclitaxel

The European Directorate for the Quality of Medicines (EDQM) has granted Indena, a world leader in 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. Milan-based Indena already holds CEPs for naturally sourced Paclitaxel.

The European Directorate for the Quality of Medicines (EDQM) has granted Indena, a world leader in 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. Milan-based Indena already holds CEPs for naturally sourced Paclitaxel.

The CEP certification provides proof that the quality of the substances used in human and veterinary medicines is suitably controlled by the relevant monographs of the European Pharmacopoeia. These certificates are recognised by all EU members and other countries including Australia, Canada and Switzerland.

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.

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