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Wockhardt gets FDA nod to sell drug in U.S.
By agencies
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Monday, 15 May 2006, 19:30 IST
MUMBAI: Wockhardt has received US Food and Drug Administration (FDA) approval for marketing ceftriaxone sodium injection, a broad-spectrum new generation antibiotic, in the US market.
Wockhardts US subsidiary, Wockhardt USA, is expected to launch this cephalosporin group antibiotic formulation in the next few weeks. Ceftriaxone sodium is the generic version of Hoffman La Roches Rocephin injection.
The approval marks Wockhardts entry into the US indictable market, Habil Khorakiwala, Wockhardt chairman, said. This is the first of nine indictable that we have filed with the US FDA. We expect to launch several more products including indictable in the US this year.
Wockhardt is one of the few companies with end-to-end integrated capabilities for this product, starting with manufacture of active pharmaceutical ingredient (API), formulations and marketing through wholly owned subsidiary in the US, enabling the company to capture maximum value.
Ceftriaxone is manufactured at the company's US FDA certified sterile cephalosporin API facility at Ankleshwar and the formulation is manufactured at the dedicated cephalosporin formulation plant at Maharashtara, which was recently approved by US FDA. Both the process for the API and the injection were developed through in-house research.
With Ceftriaxone, Wockhardt now has 12 products in the US market now, compared to five last year. Wockhardt has over 20 products awaiting US FDA approval.