Wockhardt to launch ulcer drug Ranitidine in the US

26 February 2009

Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food and Drug Administration (US FDA) for marketing ulcer drug Ranitidine.

Wockhardt said it will launch alcohol-free Ranitidine syrup in the US market containing 15mg/ml Ranitidine hydrochloride.

In addition, Wockhardt said, it has also received tentative approval for an alcohol-containing formulation of Ranitidine. The patent on this product will expire on 26 May 2009.

Ranitidine, which is used for ulcers and hyperacidity, is the generic name for the brand `Zantac', marketed in the United States by Glaxo SmithKline.

According to IMS, the total market for Ranitidine syrup in the US is $51 million.

''Since the acquisition of Morton Grove in October 2007, Wockhardt is now a leading player in the liquid products segment in the US,'' said Wockhardt chairman Habil Khorakiwala. ''This is our first liquid product approval from our new plant based at Baddi, in Himachal Pradesh,'' he added.