Glenmark Pharmaceuticals Ltd., a research-based pharmaceutical company headquartered in Mumbai (India), received tentative approval from the US FDA for its 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.
Glenmark is manufacturing the finished dose formulation at its US FDA approved manufacturing facility in Goa, India. Glenmark's US subsidiary, Glenmark Pharmaceuticals Inc., USA (GPI) will start marketing the product in the US upon patent expiry on June 30, 2007, a company press release said.
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.
Glenmark's US subsidiary, Glenmark Pharmaceuticals Inc., USA (GPI), was established in 2003 to enter into the world's largest pharmaceutical market. GPI is responsible for sales and marketing of generic drug formulations in the USA as well as APIs to customers in the regulated markets. GPI closed last fiscal year with sales of USD 50 million from its formulations business.