News
Wockhardt receives USFDA approval for Cefotaxime Injection
Pharmaceutical and biotechnology major Wockhardt Limited 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 Wockhardt 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."
Wockhardt's US subsidiary,Wockhardt USA Inc., will launch this 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.
Wockhardt currently markets 14 products in the US.
Wockhardt is one of the few companies with end-to-end integrated capabilities for its products, starting with manufacture of the sterile API, the injection and marketing through the 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 is now in Phase II human clinical trials. The US and European Union contribute to half of Wockhardt's sales.