Wockhardt's Cefotaxime injection receives US FDA approval
31 August 2006
Mumbai: Pharmaceutical major Wockhardt Ltd has received approval from the United States Food & Drug Administration (US FDA) for marketing Cefotaxime sodium (1 gm) injection in the US market.
Cefotaxime sodium is the generic version of Sanofi Aventis Claforan injection and is a broad-spectrum antibiotic used in treating a wide variety of infections.
"This is our second approval for sterile cephalosporins, and our sixth approval in the last eight months," said company chairman Habil Khorakiwala. "The rapid build-up of portfolio is helping us make our presence felt in the US - the world''s largest pharmaceutical market," he added.
Wockhardt's US subsidiary, Wockhardt USA Inc., will launch the cephalosporin antibiotic in the US market within the next few weeks.
Cefotaxime sodium is manufactured at the US FDA certified sterile cephalosporin API (active pharmaceutical ingredient) facility at Ankleshwar and the injection is manufactured at the sterile formulation plant at Waluj. The processes for both API and the injection were developed in-house.
The company currently markets 14 products in the US. The US and European Union together contribute nearly half of Wockhardt's sales.
Wockhardt has end-to-end integrated product capabilities, starting with manufacture of the sterile API, the injection and marketing through the wholly owned subsidiary in the US.
Wockhardt Limited has an active multi-disciplinary research programme employing around 400 scientists. Its new drug discovery programme has yielded several promising new molecules, one of which is now in Phase II human clinical trials.