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Ranbaxy gets Donepezil Hydrochloride tablets manufacturing approval from FDA

Ranbaxy Laboratories Limited has received the US Food and Drug Administration (FDA) final approval to manufacture and market generic formulation of Aricept, Donepezil Hydrochloride tablets 5mg and 10mg, with 180-day market exclusivity in the US healthcare system.

Aricept (donepezil HCl) is a prescription medicine to treat mild, moderate and severe alzheimer’s disease.

Ranbaxy Pharmaceuticals Trade Sales vice president Bill Winter said that they are pleased to announce the launch of Donepezil, which expands Ranbaxy’s portfolio of affordable generic pharmaceuticals.

"Ranbaxy‘s generic formulation of Aricept will benefit the US healthcare system by providing a more affordable treatment option to patients, which will have a positive impact on escalating US healthcare costs," Winter said.

Ranbaxy managing director Arun Sawhney said that the launch of a generic formulation of Donepezil tablets will provide patients with a cost effective alternative.

Ranbaxy Pharmaceuticals is a wholly owned subsidiary of Ranbaxy Laboratories Limited.