The approval comes through Health Canada, the regulating health-care agency of Canada.
PharmaRoth CEO Luis Lopez said: "We are very excited that our product is expanding into the North American market. We expect this approval to open the door for countries around the world to accept Sucanon as an effective solution to the global Type-II diabetes epidemic.
"Many countries look to the US, Canada and the EU for guidance in these matters, making this a landmark approval.
"This approval, along with our new retail relationship in Mexico, is the culmination of many months of hard work, and we feel that the Company is properly positioned for a new and more prosperous future."