Ranbaxy gets approval to market Donepezil tablets in Canada

New Delhi January 9, 2014: Ranbaxy Laboratories’ Canadian subsidiary Ranbaxy Pharmaceuticals Canada Inc has received approval to manufacture and sell Donepezil Hydrochloride 5 mg and 10 mg. The drug is used to treat dementia in patients suffering from Alzheimer’s, the company said in a statement on Wednesday.

According to the company, the total market size for the drug in Canada was 153.9 million Canadian dollars in November 2013 and is growing at about 38 per cent.

Paul Drake, President, Ranbaxy Pharmaceuticals Canada, said the medicines will be manufactured at Ohm Laboratories located in New Jersey, US.

Ranbaxy came in the firing line for regulatory issues last year. In May last year, the company made a $500-million legal settlement in the US after pleading guilty to drug safety violations. Later, in September the US Food and Drugs Administration (FDA) also issued an import alert on Ranbaxy’s third Indian plant at Mohali.

Further, in December 2012, Ranbaxy’s Ohm Laboratories had also come under the US FDA lens for failing to comply with the current good manufacturing practices. It received a clean chit only in October 2013. Ohm Laboratories is the only manufacturing facility catering to the US market since all three Indian plants — Mohali, Paonta Sahib and Dewas — are barred from manufacturing drugs for the US. Business Standard