Indena´s Myrtocyan and Valeroselect 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.

7 Apr 2010 --- The European Directorate for the Quality of Medicines (EDQM) has recently granted Indena a “Certificate of Suitability of the European Pharmacopoeia (CEP)” for two products: bilberry fruit dry extract refined and standardized (Vaccinium myrtillus L. dry extract - Myrtocyan) and Valerian dry hydroalcoholic extract (Valeroselect). They are among the first few herbal drug preparations available in the market to be CEP certified.

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: “thanks to the CEP certification, which is widely accepted as a recognition of quality, our customers can avoid to submit process and quality control documentation for the active substance covered by the CEP and the time-to-market is shortened. All this results 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 by FDA.

Indena has been working on bilberry extract since early Seventies and their standardized extract of Vaccinium myrtillus L. is the gold standard for the market.

The company already holds CEPs for naturally sourced Paclitaxel and for Paclitaxel from semisynthesis, as well as for Colchicine.