Orchid receives USFDA approvals for Cefotaxime Injection ANDAs

Orchid Chemicals & Pharmaceuticals Ltd has announced that on August 16, 2006, the Company has received the formal approval from the USFDA for 3 of its ANDAs (Abbreviated New Drug Applications) for Cefotaxime for 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 would be launching 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.

The Company has filed 31 ANDAs with the USFDA till date and the number of ANDAs approved by the USFDA stands at 15.

Source : Equity Bulls

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