Naturex receives first ever CEP certification for a devils claw extract
Avignon, 24th October 2013 - New drug developments for healthy joints and pain relief will benefit from the first devil’s claw extract to be granted CEP.
Devil’s claw is the 6th botanical extract to join the short list of herbal drugs with Certification of Suitability to the monographs of the European Pharmacopoeia (CEP). By granting this certification, the European Directorate for the Quality of Medicines & Health Care (EDQM) recognizes that Naturex’s devil’s claw extract is safe and fully compliant with the European Pharmacopoeia tests and specifications. As a prerequisite of the dossier, the manufacturing site operates under full pharmaceutical GMP (ICH Q7). “Being granted the first ever CEP certification for a devil’s claw extract is a fitting acknowledgement of the extensive work of our teams during the rigorous registration process,” stated Pierfrancesco Nannipieri, global pharmaceutical regulatory affairs manager.
“Beyond the compliance of the devil’s claw extract with the European Pharmacopoeia, this certification will fully benefit our customers,” said Maxime Angelucci, head of sales for Europe and Africa. “The CEP is widely accepted and helps to shorten the time-to-market for new drug developments because the API (Active Pharmaceutical Ingredient) receives immediate approval. This removes a number of constraints for the client, as an individual assessment of the API by each national authority is no longer necessary.”
“Moreover, the CEP is not only relevant to the European Union member states. A growing number of authorities acknowledge this certification as part of an expedited registration process in countries such as Canada, Australia, New Zealand, Tunisia, and Morocco,” he added.
According to the monograph on harpagophytum procumbens from the European Medicines Agency, certain therapeutic indications are permitted for CEP-certified devil’s claw. For example, companies may promote it as a “traditional herbal medicinal product for relief of minor articular pain.”
This certificate is a good complement to Naturex’s collection of over 30 APIs approved for sale in Europe.
About Naturex:
Naturex is the global leader in specialty plant-based natural ingredients. Through its dedicated business units, the Group addresses the specific needs of 3 strategic markets: Food & Beverage, Nutrition & Health, and Personal Care. The company offers its customers a full array of high quality ingredients, responsibly sourced from nature for food, pharmaceutical, nutraceutical and cosmetic applications.
Naturex’s head office is Avignon, France. The company employs more than 1,400 people and benefits from 8 sourcing offices around the world and high-performance manufacturing operations across 15 sites in Europe, Morocco, the United States, Brazil, Australia, and India. It also has a global commercial presence through a dedicated network of sales offices in more than 20 countries.
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