Wockhardt has received approval from the US Food & Drug Administration (US FDA) for marketing cefotaxime sodium 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. The company's US subsidiary – Wockhardt USA Inc – will launch the cephalosporin antibiotic in the market within a few weeks.
"This is our second approval for sterile cephalosporins, and our sixth approval in the last eight months," said Habil Khorakiwala, chairman, Wochardt group.
Cefotaxime sodium is manufactured at the company's 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.
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