Orchid gets US nod for new drug

Orchid Chemicals and Pharmaceuticals Ltd has received approval from USFDA for three of its Abbreviated New Drug Applications (ANDAs) for Cefotaxime in injection form.

MUMBAI: Orchid Chemicals and Pharmaceuticals Ltd has received approval from USFDA for three of its Abbreviated New Drug Applications (ANDAs) for Cefotaxime in injection form.

The company received USFDA nod for Cefotaxime in dosages of 500mg, 1gm and 2gm single-dose vials, 1gm and 2gm piggyback vials and 10gm pharmacy bulk package vials, it informed the Bombay Stock Exchange.

Orchid would launch Cefotaxime, a generic version of Sanofi Aventis' Claforan, in the US through its exclusive distribution partner Apotex.

Though a mature off-patent product, Cefotaxime has limited competition thus enabling a notable market-share and revenue stream for the company, Orchid said.

The company has filed 31 ANDAs with the USFDA till date and 15 ANDAs have been approved.
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