Glenmark receives approval for Topiramate tablets

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Glenmark receives approval for Topiramate tablets

Glenmark receives tentative US FDA approval for its ANDA for Topiramate Tablets

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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).

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 USFDA 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.

Sourced From: Glenmark Pharmaceuticals Limited