Glenmark Pharmaceuticals Ltd. (Glenmark), a research-based pharmaceutical company headquartered in Mumbai (India) received tentative approval from the US FDA for its Abbreviated New Drug Application (ANDA) for topiramate tablets in multiple strengths (25 mg, 50 mg, 100 mg and 200 mg).
According to a company press release, the branded sale of topiramate tablets, an anti-epileptic drug, which falls in the CNS segment, is estimated at $1.85 billion in 2006 as per NDC Health.
Glenmark will manufacture 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 (September 26, 2008).
With this approval, GPI now has a portfolio of 18 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.