Glenmark Pharmaceuticals receives US FDA approval for Terbinafine Hydrochloride tablets

Glenmark Pharmaceuticals Ltd has announced that the Company has received a final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Applications (ANDAs) for Terbinafine Hydrochloride Tablets, 250 mg (base).

It is the AB-rated generic equivalent of Novartis's anti-fungal Lamisil® tablets with annual sales of over USD 650 million (IMS-Dec 2006) in the US.

The Company is manufacturing the finished dose formulation at its USFDA approved manufacturing facility in Goa, India. The Company's US subsidiary, Glenmark Pharmaceuticals Inc., USA (GPI) will start marketing the product in the US.

With this approval, GPI now has a portfolio of 19 generic products for the US market and has over 35 ANDAs undergoing US FDA approval process / launch.

Source : Equity Bulls

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