Glenmark gets tentative USFDA nod for Terbinafine tabs

MUMBAI: Pharma company Glenmark Pharmaceuticals (GPI) on Thursday said it has received tentative approval from United States Food and Drug Administration (USFDA) for Terbinafine HCL tablets, used in the treatment of fungal infections.

With this approval, GPI now has a portfolio of 16 generic products for the US market and over 35 ANDAs undergoing USFDA approval process or launch, Glenmark said in a communique to the Bombay Stock Exchange (BSE).

Glenmark is manufacturing the finished dose formulation at its USFDA approved manufacturing facility in Goa and its US subsidiary, Glenmark Pharmaceuticals Inc (GPI), would start marketing the product in that country.

Terbinafine HCL is the AB-rated generic equivalent of Novartis's anti-fungal Lamisil tablets with annual sales of over 650 million dollar in the US as per IMS-Dec-2006 data, it added.

Glenmmark shares were trading at Rs 667.30, up 0.35 per cent on BSE.