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news.Labopharm Inc has initiated the regulatory approval process in Mexico for its once-daily formulation of pain drug tramadol by submitting a marketing application to the Mexican regulatory authority.
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Labopharm is leveraging regulatory approval of the product in France, which will serve as first approval status in a major regulatory jurisdiction, to facilitate the regulatory approval process in Mexico, the world’s ninth largest pharmaceutical market.
The company’s once-daily tramadol product has been approved in France for the treatment of moderate to severe pain.
“It is our plan to commercialize our once-daily tramadol product in key markets around the world in addition to Europe and the US, including Latin America, Southeast Asia and Australia, all of which represent sizeable tramadol markets,” said James Howard-Tripp, president and CEO of Labopharm.
“Similar to our commercialization strategy in Europe, our intent is to partner with a leading pharmaceutical company for marketing and distribution of our product and we are in active discussions with a number of potential partners in this regard,” he continued.