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.
Wockhardt says the Ranitidine syrup will be manufactured at the US FDA-certified formulation plant at Baddi, Himachal Pradesh. Both the versions of this product were developed in-house.
Wockhardt is already amongst the market leaders in both prescription and OTC segments of Ranitidine tablets. The addition of the liquid products will provide further boost to its Ranitidine franchise, Wockhardt said.
Wockhardt now supplies products to the US and Europe from seven formulation and five API facilities in India.
The Indian pahrmaceutical and hospital chain operator said that it is one of the top 5 companies in the world to have received 23 abbreviated new drug approvals (ANDA) - the highest number certified by the US FDA for 2008.
Wockhardt has five research centres and 15 world-class manufacturing plants in various countries and continents that are compliant to international regulatory standards, including US FDA and MHRA. It has a presence in the major markets like the US, the UK, Ireland, France and Germany.