Wockhardt receives US FDA approval for Ranitidine OTC version

27 February 2006

Pharmaceutical and biotechnology company Wockhardt Limited has received the US FDA approval for marketing Ranitidine 75mg tablets as an over-the-counter (OTC) product in the US market.

Wockhardt's US subsidiary, Wockhardt USA Inc., is expected to launch the anti-ulcer drug shortly. According to IMS data, the current market for this product in the US is $61 million with a unit growth rate of 17 per cent.

Ranitidine is the generic version of Pfizer's Zantac 75 tablets. "Wockhardt is already a major player in the US Ranitidine prescription market, with its 150 mg and 300 mg tablets," executive director Lalit Kumar said. "The prescription tablets launched in 2002 have steadily increased their market shares. With the addition of the OTC version, we will now have the full range of Ranitidine medications in the US."

This is the second ANDA (abbreviated new drug application) approval for Wockhardt in 2006. The US became Wockhardt''s fastest growing market in 2005, recording a 50 per cent growth in formulation sales. It has improved its market shares in two key products in the US in 2005- bethanechol chloride to 44 per cent from 40 per cent and enalapril to 28 per cent from 20 per cent.

Ranitidine OTC will be the twelfth product to be marketed under the Wockhardt banner in the US and second OTC drug to be marketed in the US after famotidine. Wockhardt has another 21 applications pending with US FDA.

Wockhardt manufactures the active pharmaceutical ingredient (API) and the tablets at its US FDA-approved facilities in Aurangabad, Maharashtra, India.