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Glenmark Pharmaceuticals receives US FDA approval to market generic Gabapentin



Posted On : 2006-08-24 04:28:54( TIMEZONE : IST )

Glenmark Pharmaceuticals receives US FDA approval to market generic Gabapentin

Glenmark Pharmaceuticals Ltd has announced that Glenrnark Pharmaceuticals, Inc., USA (GPI), the wholly owned US subsidiary of the Company, received US FDA approval to market Gabapentin oral tablets 600 mg and 800 mg. Gabapentin belongs to a category of anti-convulsants and is prescribed to help control epileptic seizures. It is also widely used to relieve different kinds of pain and even psychiatric disorders. The drug enjoys a generic market size of USD 328 million.

The Company manufactures the drug at its solid-oral formulation facility at Goa and will commence shipments of Gabapentin immediately. Gabapentin is the fourth ANDA filed by the Company from the Goa facility to receive US FDA approval after Fluconazole, Zonisamide and Meloxicam. With this approval, the Company will have ten generics on the market including two controlled substances: Codeine Phosphate launched in June and Morphine Sulphate which is in the process of being launched.

Source : Equity Bulls

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