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Glenmark gets USDFA nod for ulcer tablets

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BS Reporter Mumbai
Last Updated : Jan 19 2013 | 10:59 PM IST

Glenmark Generic, a US subsidiary of Glenmark Pharmaceuticals, has received Abbreviated New Drug Application (ANDA) approval from the US Foods and Drug Admin (USFDA) for Ranitidine 150 milligrams (mg) and 300 mg tablets. The firm will soon start marketing and distribution of these products in the US markets.

Ranitidine tablets are approved for eight separate indications, including the short-term treatment and maintenance of duodenal ulcer patients, the treatment of pathological and maintenance of gastric ulcer patients, treatment of GERD (Gastro Esophageal Reflux Disease) and the treatment and maintenance of erosive esophagitis.

These varied treatment options have contributed to the overall success of the productive garnering sales of excess of $41 million for the 12 month period ended June 2008 as reported by IMS Health.

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First Published: Nov 21 2008 | 1:46 PM IST

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