Wockhardt is likely to launch clarithromycin, a broad-spectrum macrolide antibiotic, in the US market next week.
The company has already received approval from the US Food & Drug Administration for marketing clarithromycin tablets, a generic version of Abbott's Biaxin, in the $113 million US market.
The product will be launched through its US subsidiary, Wockhardt USA Inc. "This is our second abbreviated new drug application approval in the last two weeks, and the fourth this year," said Habil Khorakiwala, chairman, Wochardt.
"With more approvals expected in the second half of 2006, we will have a healthy basket of products in US," he added.
The bulk drug for clarithromycin is manufactured at Wockhardt's API facility at Ankleshwar and the tablets are manufactured at its formulation unit at Aurangabad. These two facilities have already been approved by the US FDA.
The process for the API and the tablet were developed in-house. With clarithromycin, Wockhardt has now 13 products in the US market, compared to the five last year. The company has over 20 products that await US FDA approval.
Wockhardt is one of the few companies with end-to-end integrated capabilities for the product, starting with manufacture of active pharmaceutical ingredient, formulations and marketing through wholly owned subsidiary in the US, enabling it to capture the maximum value.
The company is a technology-driven pharmaceutical and biotechnology company with an active multi-disciplinary research programme employing 400 scientists.
Its new drug discovery programme has yielded several promising new molecules, one of which has entered Phase II human clinical trials.
Currently, the US and EU contribute almost 50 per cent of the company's sales. In order to expand in the US generics market, the company is scouting for suitable acquisitions, which would offer a readymade product basket as well as an established market network in the US market.
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