Ranbaxy Laboratories has received a final approval from from Health Canada, therapeutic products directorate (TPD) to manufacture and market Ran-Simvastatin tablets (Simvastatin) in Canada. Ran-Simvastatin tablets are indicated for use as a lipid metabolism regulator.
The tablets come in doses of 5mg, 10mg, 20mg, 40mg and 80mg. The total generic market size of Simvastatin tablets in Canada is C$153 million, according to a company press release.
''Ran-Simvastatin represents the second approval granted to RPCI in July that will further expand the depth and breadth of our product portfolio of molecules that have clinical utility and value. We plan to launch Ran-Simvastatin in a September timeframe,'' said Paul Drake, president, RPCI.
"We look forward to marketing this organically developed product in all strengths that will be commercialised at an affordable price," Drake said.
The company has also received approval to market and manufacture Ran-Amlodipine tablets, used in treating hypertension.
"We look forward to marketing both strengths of Ran-Amlodipine tablets at affordable prices that will be beneficial to both the Canadian healthcare system, and most importantly to Canadian patients," Drake said.