Glenmark receives US FDA nod for Terbinafine HCL

New Delhi, June 21 (UNI) Pharma company Glenmark Pharmaceuticals Ltd today said it has received tentative approval from the US FDA to manufacture and market its ANDA oral tablets Terbinafine HCL in the strength of 250 mg.

It is the AB-rated generic equivalent of Novartis's anti-fungal Lamisil tablets with annual sales of over 650 million dollars in the US, a statement said.

The company is manufacturing the finished dose formulation at its US FDA approved manufacturing facility in Goa.

The company's US subsidiary, Glenmark Pharmaceuticals Inc, US (GPI) will start marketing the product in the US upon patent expiry.

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.

UNI