Glenmark Pharmaceuticals on Tuesday said it has received final approval from the US Food and Drug Administration for marketing Terbinafine Hydrochloride tablets in that country, used to treat a wide range of fungal skin infections.
Glenmark received the approval for its Abbreviated New Drug Applications (ANDAs) for Terbinafine Hydrochloride tablets of 250 mg base, the company said in a filing to the Bombay Stock Exchange (BSE).
The drug is an AB-rated generic equivalent of Novartis's anti-fungal Lamisil tablets with annual sales of over USD 650 million in the US, as per IMS-December 2006.
The company is manufacturing the finished dose formulation at its USFDA approved manufacturing facility in Goa and its US-based subsidiary Glenmark Pharmaceuticals Inc would start marketing the product in that country.
With this approval, GPI now has a portfolio of 19 generic products for the US market and has over 35 ANDAs undergoing USFDA approval process.
Shares of Glenmark were trading at Rs 680, up 1.80 per cent on BSE.