Dimethaid Research announced that the Therapeutic Products Programme (TPP) of Health Canada issued a license for the manufacturing, packaging and testing of pharmaceutical solutions at its manufacturing facility in Varennes, Quebec.
"This license to manufacture is a significant step forward for our product development," said Rebecca Keeler, President and CEO of Dimethaid Research. "With Health Canada's certification, we are now in a position to submit all final documentation for our UK marketing license of Pennsaid Topical Lotion." The UK Committee on Safety of Medicines has previously recommended that a marketing authorization be granted for Pennsaid.
The license was issued after the completion of a site inspection under the Food and Drugs Act. Furthermore, under the Agreement on Mutual Recognition between Canada and the European Community, the Certificates of Manufacturing Authorizations/Licenses issued by the Canadian agency are recognized by regulatory agencies in Europe.
Dimethaid Research is a pharmaceutical company engaged in the development and commercialization of innovative site-specific therapeutic products that minimize the unwanted systemic side effects of drugs on the body. The Company has developed a proprietary transdermal delivery system that facilitates the delivery of drugs to the site of disease with minimal systemic absorption.