The traditional herbal medicine status, granted by the Drug Control Authority of Malaysia (DCA), marks the first such status for the product globally. In the US the product is sold as a food supplement under the brand Ellura.
The new status achievement now enables the firm’s Malaysian partner YSP Industries to distribute the cranberry supplement to hospitals and clinics under the brand name Shine Urell.
Gunter Haesaerts, founder and owner of Pharmatoka, said this will grow business substantially.
“Pharmatoka, together with its partners, can now start to build durable worldwide markets for reliable, efficacious products that can help millions of women worldwide to reduce and even eliminate the recurrence of urinary tract infections caused by E.coli bacteria,” Haesaerts told FoodNavigator-Asia.
Southeast Asia doors?
“The Malaysian market for efficacious cranberry supplements or herbal medicines is very small,” he said.
“We can now start to create awareness with doctors, pharmacists and all health care providers who are confronted with the issue of growing resistance of urophatogenic E.coli bacteria against commonly used antibiotics,” he said.
He noted however, that the supplement is not intended to replace antibiotics, but to be used as a preventative device long-term.
“Malaysia will be an important market in Southeast Asia, where we are building awareness for the concept of bacterial anti-adhesion,” he said, and this status for Urell should spark wider awareness.
By the end of 2012, the product will be available in some pharmacy circuits in addition to hospitals and clinics, he revealed.
Haesaerts said that Pharmatoka is driving efforts to introduce the concept in seven other “important markets across the world,” revealing that 2013 should bring substantial breakthroughs.
“We are convinced that this development shows the way to go for food supplements that have proven their biological efficacy and are backed up by solid science,” he said.
Underpinned by a strong partnership
Pharmatoka has been working with its local partner YSP Industries for more than four years, Haesaerts detailed.
This firm was chosen as it is “one of the leading pharma and over-the-counter (OTC) producers in Southeast Asia,” he added, with traction across the globe.
YSP Industries worked directly with authorities, gathering all clinical and other data and the full characterisation of the cranberry juice extract powder to compile into a common technical document (CTD) dossier.
“We owe a lot to the perseverance of the YSP team who have obtained this status…They had to build the dossier from A to Z because Pharmatoka did not, at that time, have its own CTD dossier,” Haesaerts said, “that is why it took more than three years to assemble the necessary data and fill in all the modules of the Malaysian CTD.”
