Wockhardt Limited has received US FDA approval for marketing bethanechol chloride tablets in the US. With this, it will be the only generic alternative to Urecholine of Odyssey Pharmaceuticals in the US Market. Until now, the extremely complex technology involved in the manufacture of the drug had prevented the entry of a generic version.

Sales of Urecholine, used in the management of disorders of the urinary tract and bladder, totalled $46 million during the 12 months to April 2003, an increase of 31% over the previous year. As there are no outstanding patents for this product, Wockhardt will be launching the product soon as the only generic alternative to the branded product.

The company sources said that the product would be marketed in the US through a strategic alliance with Ranbaxy Pharmaceuticals Inc. This is the third Wockhardt product to be marketed in the US through Ranbaxy Pharmaceuticals.

Wockhardt is manufacturing the tablets in 5 mg, 10 mg, 25 mg and 50 mg dosage forms at its Aurangabad plant. This is Wockhardt's sixth ANDA (abbreviated new drug application) approval in the US market. The company already owns over 30 active US Drug Master Files for bulk actives and several other filings are in the pipeline.