Wockhardt gets US nod to market bethanechol chloride tablets
Our Corporate Bureau / Mumbai October 3, 2003
Pharmaceutical major Wockhardt Ltd has received the US Food and Drug Administration (US FDA) approval for marketing bethanechol chloride tablets.
As there are no outstanding patents for this product, Wockhardt will be launching it as the only generic alternative to the branded product (Urecholine of Odyssey Pharmaceuticals).
“Our research team faced a dual challenge: One was to develop a technology to produce the complex molecule and the other was to formulate it in tablet dosage form. It is a matter of pride that Wockhardt has managed to breach the entry barriers and that ours will be the only generic version in the US market,” said Habil Khorakiwala, chairman, Wockhardt.
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 per cent over the previous year.
The drug will be marketed in the US through a strategic alliance with Ranbaxy’s US operations based in Princeton, New Jersey. This is the third Wockhardt product to be marketed in the US through Ranbaxy Pharmaceuticals.
It took about a year for Wockhardt’s scientists to develop, scale up and perfect the technology for the active ingredient and formulate it into tablets. 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 abbreviated new drug application approval in the US market. Wockhardt already owns over 30 active US drug master files for bulk actives.
Wockhardt gets US nod to market bethanechol chloride tablets
Our Corporate Bureau / Mumbai Oct 03, 2003, 00:00 IST
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