Orchid Chemicals & Pharmaceuticals, a leading player in the Indian drug industry, has received a formal approval from the US Food and Drug Authority (FDA) for three of its abbreviated new drug applications (ANDAs) for Cefotaxime.
Orchid will be launching this product in the US through its exclusive distribution partner, Apotex, the Chennai-based company said in a release Wednesday.
The FDA approvals for Cefotaxime ANDAs mark another milestone in Orchid's efforts to offer a full-line injectable product range in the US generic market, it said.
Though a mature off-patent product, Cefotaxime has limited competition and Orchid expects a notable market share and revenue stream from it.
Orchid has filed 31 ANDAs with the FDA and 15 of them have been approved so far.