Glenmark Pharmaceuticals received tentative US FDA approval for its ANDA for Topiramte Tablet

Glenmark Pharmaceuticals Ltd has announced that the Company has received a 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 & 200 mg).

The branded sale of Topiramate tablets, an anti-epileptic drug, which falls in the CNS segments, is estimated at $1.85 billion in 2006 as per NDC Health.

The Company will manufacture 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 (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 UD FDA approval process / launch.

Source : Equity Bulls

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