Wockhardt receives US FDA approval for clarithromycin tablets
01 June 2006
Mumbai: Pharmaceutical and biotechnology major Wockhardt Limited has received approval from the US Food and Drug Administration (US FDA) for marketing Clarithromycin tablets in the US market.
Wockhardt's 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 $13 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 Habil Khorakiwala, chairman, Wockhardt. "With more approvals expected in the second half of 2006, we will have a healthy basket of products in the US," he added.
Clarithromycin is manufactured at Wockhardt's US FDA-approved API facility at Ankleshwar and the tablets are manufactured at the formulation unit at Aurangabad, also approved by the US FDA. The process for the API and the tablet were developed through in-house research.
With Clarithromycin, Wockhardt now has 13 products in the US market, compared to five last year. Wockhardt has over 20 products awaiting US FDA approval.
Wockhardt 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.
Wockhardt Limited 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 Wockhardt's sales.