Glenmark gets US FDA approval for marketing Ranitidine

21 November 2008

Glenmark Generics Ltd's, the US subsidiary of Glenmark Pharmaceuticals, has received ANDA approval from the United States Food and Drug Administration (US FDA) for Ranitidine 150 mg and 300 mg tablets and will soon commence marketing and distribution of these products in the US market.

Ranitidine tablets are used for short-term treatment and maintenance of duodenal ulcer patients, pathological hypersecretory conditions, term treatment and maintenance of gastric ulcer patients, treatment of GERD (GastroEsophageal Reflux Disease) and the treatment and maintenance of erosive esophagitis.

These varied treatment options have helped the product garner sales in excess of $41 million for the 12 month period ended June 2008, according to IMS Health report.

''This recent approval will be the third product added to the US subsidiary's product portfolio within the month of November alone. GGI has already completed two launches earlier this month, ie, morphine sulfate solution oral concentrate 20mg in three presentations as well as azathioprine tablets 50mg,'' Terrance Coughlin, CEO of Glenmark Generics, said.

''These three launches will give a significant boost to our product portfolio and generate good sales for the subsidiary,'' he added.

Glenmark's current portfolio consists of 37 generic products authorised for distribution in the US market. The company currently has 40 ANDAs filed with the US FDA pending approval.