Corporate News     26-Oct-12
Unichem Laboratories receives ANDA tentative approval for Memantine Hydrochloride Tablets
From USFDA
Unichem laboratories has announced that it has received ANDA tentative approval from the United States Food and Drug Administration (USFDA) for Memantine Hydrochloride Tablets. Final approval will be received after the patent expires on 11 April 2015.

Memantine Hydrochloride Tablets 5mg and 10mg are therapeutically equivalent to Namenda Tablets 5mg and 10mg of Forest Laboratories Inc. Memantine Hydrochloride is used to treat moderate to severe dementia of the Alzheimer's type.

Further, it reduces the actions of chemicals in the brain that may contribute to the symptoms of Alzheimer's disease. The product will be commercialized from Unichem's Goa plant. Active pharmaceutical ingredient i.e. Memantine Hydrochloride used for this ANDA is also made in house at Pithampur plant. The market size is US$ 1.5 billion as of March 2012 at brand price.

The company made this announcement during the trading hours today, 26 October 2012.

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