Orchid Chemicals and Pharmaceuticals Ltd has received the formal approval from the US FDA for three of its ANDAs (Abbreviated New Drug Applications) for Cefotaxime injection in various dosage forms. These pertain to 500mg, 1gm and 2gm single-dose vials, 1gm and 2gm piggyback vials and 10gm pharmacy bulk package vials.
Cefotaxime is the generic version of Sanofi Aventis' Claforan. The company is planning to launch this product in the US through its exclusive distribution partner, Apotex.
The approvals for the Cefotaxime ANDAs mark another milestone in the company's efforts to offer a full-line injectable produce range in the US generic market. Though a mature off- patent product, Cefotaxime has limited competition thus enabling a notable market-share and revenue stream for the company.
Orchid has filed 31 ANDAs with the US FDA till date and the number of ANDAs approved by the US FDA stands at 15.