Glenmark Azathioprine tablets approved in US

Thursday, December 4, 2008, 10:27 by Business Editor

Glenmark Pharmaceuticals, the pharmaceutical company headquartered in Mumbai, India, has said it has received marketing rights in the United States for its Azathioprine 50-mg tablets, which are used to prevent rejection in kidney transplantation.

The company said that it would market the drug through Glenmark Generics Limited, its subsidiary based in the United States.

Azathioprine, the generic equivalent of Imuran tablets, is also indicated in the management of active rheumatoid arthritis to reduce signs and symptoms, according to the company.

Glenmark is authorised to distribute 130 SKUs in the United States.

At present, Glenmark has 40 Abbreviated New Drug Application (ANDA) in various stages of approval process with the United States Food and Drug Administration (FDA).

According to IMS Health, the international consulting and data services company that supplies the pharmaceutical industry with sales data and consulting services, total sales for Azathioprine for the 12-month period ending June 2008 was worth about US $36 million.

Glenmark Pharmaceuticals said it also has received approval from the United States Food and Drug Administration for distribution and marketing of Ranitidine tablets in the US market.

Ranitidine tablets are used to treat duodenal ulcers and gastric ulcers as well as erosive esophagitis.

The company says that “Ranitidine decreases acid in the stomach to help treat an ulcer or prevent one from developing; it also helps to decrease the stomach pain, diarrhea, and loss of appetite that ulcers can cause.”

Glenmark said it would soon start marketing and distribution of Ranitidine 150-mg and 300-mg tablets in the United States.

Ranitidine tablets are approved for eight separate indications, including the short-term treatment and maintenance of duodenal ulcer patients, the treatment of pathological hypersecretory conditions, the short-term treatment 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, according to IMS Health, have contributed to the overall success of Ranitidine tablets achieving sales worth over US $41 million for the 12-month period ended June 2008.

Glenmark said it has currently 37 generic products authorised for distribution in the US market and that “it continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.”

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