Wockhardt to launch generic version of ulcer drug Ranitidine syrup in the US market
Mumbai : Pharmaceutical and biotechnology major Wockhardt will be launching Ranitidine syrup in the United States. Wockhardt received final approval from the United States Food & Drug Administration (US FDA) for marketing the alcohol-free syrup containing 15mg/ml Ranitidine hydrochloride, which is used for ulcers and hyperacidity. Ranitidine 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.
In addition, Wockhardt has also received tentative approval for an alcohol containing formulation of Ranitidine. The patent on this product will expire on May 26, 2009.
“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 further added.
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. In the prescription generic pharmaceutical market, Wockhardt has been consistently growing market shares for all its products.
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 now supplies products to the US and Europe from seven formulation and five API facilities in India.
Wockhardt was one of the top 5 companies in the world to have received the highest number of 23 Abbreviated New Drug Approvals [ANDA] by the US FDA for 2008 [source Generics Bulletin 2009].
Wockhardt is a technology-driven global pharmaceutical and biotechnology major with an innovative multi-disciplinary research and development programme. It has 5 research centres and 15 world-class manufacturing plants dotting various countries and continents that are compliant to international regulatory standards such as the US FDA, MHRA or other global regulatory bodies. It has end-to-end integrated capabilities for its products, starting with manufacture of the oral and sterile API’s, the dosage forms and marketing through its wholly owned subsidiary in the US. Wockhardt has a global footprint including the USA, UK, Ireland, France, and Germany with a multi-ethnic workforce from 14 different nationalities.
March 03, 2009