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Drug firm Unichem Laboratories has received US health regulator’s approval to market its Memantine Hydrochloride tablets USP, used to treat severe dementia of the Alzheimer’s type, in the American market.
In a regulatory filing, the company said that it has received final nod from the US Food and Drug Administration (USFDA) for its ANDA (Abbreviated New Drug Application) for Memantine Hydrochloride tablets USP.
Unichem’s product is therapeutically equivalent to Forest Laboratories Inc’s Namenda tablets, it added.
Memantine Hydrochloride tablets are indicated for treatment of moderate to severe dementia of the Alzheimer’s type.
The product would be commercialised from Unichem’s Goa plant and the API (Active Pharmaceutical Ingredient) of the product would also be produced in house at its Pithampur plant, the company said.
Unichem now has a total of 19 ANDA approvals from the USFDA.
Shares of the Unichem Laboratories today ended at Rs 305.95, up 1.48 per cent on the BSE.
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