The company has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Gemifloxacin Mesylate tablets in the strength of 320 mg, Orchid Chemicals & Pharmaceuticals said in a filing to BSE.
The approval is with 180 days of generic drug exclusivity, it added.
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Chennai based Orchid Chemicals & Pharmaceuticals is present in segments like anti-infective, anti-inflammatory, central nervous system (CNS), cardio vascular segment (CVS), nutraceuticals and other oral and sterile products.
Shares of Orchid Chemicals & Pharmaceutical today closed at Rs 49.35 per scrip on BSE, up 9.30 per cent from its previous close.