Ranbaxy Laboratories Ltd has informed that Ranbaxy Pharmaceuticals Canada Inc. (RPCI), a wholly owned subsidiary of the company, has received approval in Canada to manufacture and market Ran - Pravastatin tablets, 10 mg, 20 mg, and 40 mg, from health Canada, Therapeutic Products Directorate (TPD). Total annual market sales for Pravastatin in Canada are CAD $72.9 million.
Pravastatin is indicated as an adjunct to diet for the reduction of elevated total and low-density lipoprotein cholesterol levels in patients with primary hypercholesterolemia (types IIa and IIb), in hypercholestcrolemic patients without clinically evident coronary heart disease, and in patients with total cholesterol in the normal to moderately elevated range who has clinically evident coronary heart disease.
"We are pleased to receive this approval for RAN-Pravastatin to expand the number of product offerings that Ranbaxy commercialises in Canada. This molecule will add breadth to our expanding generic product portfolio that offers affordable generic alternatives to the brand that will now be accessible to all Canadians. We estimate product being available by June 2007 to all classes of trade," said Paul Drake, president and general manager, RPCI. He further added, "Ranbaxy's presence in Canada was established in the latter part of 2005 and our efforts to expand our business was fueled through inorganic product strategies. This approval is based on our organic product strategy, that utilizes the internal R&D expertise and capabilities of our parent company, Ranbaxy Laboratories Ltd. Going forward, this will become the primary pathway for future additions to our basket of products."
Ranbaxy Pharmaceuticals-Canada Inc (RPCI) is based in Mississauga, Ontario, Canada, is a wholly owned subsidiary of the Company. RPCI is engaged in the sale and distribution of generic prescription products in the Canadian healthcare system.