Glenmark receives tentative US FDA approval for its ANDA for Terbinafine HCL tablets

Glenmark Pharmaceuticals Ltd has announced that the Company has received tentative approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Terbinafine HCL 250 mg oral tablets. 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 upon patent expiry (June 30, 2007).

With this approval, GPI now has a portfolio of 16 generic products for the US market and has over 35 ANDAs undergoing US FDA approval process / launch.

The stock was trading at Rs.666, up by Rs.1 or 0.15%. The stock hit an intraday high of Rs.683 and low of Rs.665. The total traded quantity was 93088 compared to 2 week average of 97795.

Source : Equity Bulls

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