Wockhardt Ltd received approval from the US FDA for marketing Clarithromycin tablets in the US market. Its US subsidiary, Wockhardt USA Inc., is expected to launch the broad-spectrum macrolide antibiotic within the next two weeks. As per IMS data, the current market for this product in the US is US$ 113 million. Clarithromycin is the generic version of Abbott's Biaxin tablets.
"This is our second ANDA approval in the last two weeks, and our fourth this year," said the company's chairman Habil Khorakiwala. "With more approvals expected in the second half of 2006, we will have a healthy basket of products in the US."
Clarithromycin is manufactured at the API facility at Ankleshwar and the tablets are manufactured at the formulation unit at Aurangabad, both US FDA approved plants. The process for the API and the tablet were developed through in-house research.
With Clarithromycin, the company now has 13 products in the US market, compared to five last year. The company has over 20 products awaiting US FDA approval.
The company is one of the few companies with end-to-end integrated capabilities for the product, starting with manufacture of API (active pharmaceutical ingredient), formulations and marketing through wholly owned subsidiary in the US, enabling the Company to capture 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. The US and European Union contribute to half of the company's sales.