Glenmark receives US FDA to market generic Gabapentin

New Delhi, Aug 24 (UNI) Glenmark Pharmaceuticals Ltd today said its wholly-owned US subsidiary Glenrnark Pharmaceuticals, (GPI) has received approval from US Food and Drug Administration (USFDA) to market Gabapentin oral tablets 800mg and 600mg.

Gabapentin belongs to a category of anti-convulsants and is prescribed to help control epileptic seizures. It is also used to relieve different kinds of pain and psychiatric disorders.

The drug enjoys a generic market size of 328 million dollars.

The company manufactures the drug at its solid-oral formulation facility at Goa and will commence shipments of Gabapentin immediately, a company statement said.

This is the fourth ANDA filed by the company from the Goa facility to receive the approval after Fluconazole, Zonisamide and Meloxicam.

With this approval, it 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.

UNI CS PV DS1310