Wockhardt gets US FDA Approval for Bethanechol;
To launch only generic alternative in $46m Market

Mumbai, September 30, 2003

Indian pharmaceutical major Wockhardt Limited today announced it received US FDA approval for marketing bethanechol chloride tablets in the US.

Wockhardt’s product will be the only generic alternative to Urecholine of Odyssey Pharmaceuticals. 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.

“Our research team faced a dual challenge,” said Wockhardt chairman Habil Khorakiwala. “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 managed to breach the entry barriers and that ours will be the only generic version in the US market.”

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.

It will be marketed in the US through a strategic alliance with Ranbaxy Pharmaceuticals Inc., Princeton, New Jersey. “We are delighted to partner with Ranbaxy Pharmaceuticals for this product,” Mr. Khorakiwala said. “We see Ranbaxy Pharmaceuticals Inc. as a reliable partner who could maximise the value of our product,” he said. This is the third Wockhardt product to be marketed in the US through Ranbaxy Pharmaceuticals.

“The development of the active pharmaceutical ingredient and formulations for bethanechol chloride illustrates the creativity and resourcefulness of Wockhardt in identifying a niche product,” said Brian Tempest, President of Ranbaxy Laboratories.

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. The product has been rated bio-equivalent to Odyssey Pharmaceuticals’ Urecholine.

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. Wockhardt already owns over 30 active US Drug Master Files for bulk actives and several other filings are in the pipeline.

Wockhardt Limited is a research and technology-oriented pharmaceutical company and a front runner in biotechnology. Wockhardt has an active multi-disciplinary R&D programme employing over 350 scientists. Its new drug discovery programme, started about four years ago, has yielded lead molecules, one of which, WCK-771, is currently undergoing Human (Phase-I) clinical trials. With the recent acquisition of CP Pharmaceuticals of UK, Wockhardt has joined the ranks of the top 10 generic companies in Britain. Over half of Wockhardt’s turnover comes from international markets.