22 December 2020 | Senza categoria
Cetilar® Patch and Cetilar® Tape classified as Class 2A MD
The Higher Institute for Health (ISS) has classified Cetilar® Patch and Cetilar® Tape as Class 2A Medical Devices, while the U.S. FDA recognizes the Cetylated Esters patented by PharmaNutra as GRAS substance, clearing the way for new commercial growth for the Cetilar® range products.
An intense December for PharmaNutra, which after the recent transition to the MTA market – STAR segment of the Italian Stock Exchange, announces two important certifications by the Notified Body of the Higher Institute for Health (ISS) and the U.S. Food and Drug Administration (FDA).
Cetilar® Patch and Cetilar® Tape have received from the ISS the CE certification classifying them as Class 2A Medical Devices. The two products that together with Cetilar® Crema form a line of cetylated fatty acids-based (CFA) medical devices for the well-being of muscles and joints.
This is not only a further qualitative confirmation of PharmaNutra’s products, but also a fundamental distribution step forward, as it enables the Company to commercialise Cetilar® range products at European level without needing any further certifications issued by single country authorities, as well as to obtain the free sale certificate required by non-EU Countries.
There is more. PharmaNutra’s patented Cetylated Fatty Acids (CFA) have obtained GRAS (acronym for Generally Recognized As Safe) acknowledgement. The GRAS certification will enable PharmaNutra to trade new CFA- based oral formulas in the United States, thus considerably expand its market for Cetilar® products, developed for topical use until now.
“We are really satisfied with having received these important acknowledgements for our muscle and joint product line. Firstly, because the processes were complex and kept our Regulatory and Quality Assurance department busy for a long time: Obtaining these new certifications is an important goal”, comments Germano Tarantino, Scientific Director of PharmaNutra S.p.A. “Recognising the products as Class 2A Medical Devices will enable the Cetilar® brand to grow from a commercial point of view, in Italy and abroad, where the distribution process has only just started and growth margins are exceedingly broad. Then GRAS status recognition also fits into this context, for the commercialisation of any new oral Cetylated Ester-based products: a true turning point for developing new patented formulas and CFA-based products”.