Unichem Labs receives US FDA approval for memantine hydrochloride tabs

Memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type

Unichem Laboratories has received Final ANDA approval from the United States Food and Drug Administration (US FDA) for memantine hydrochloride tablets.The 5 mg and 10 mg tablets are therapeutically equivalent to Namenda tablets, 5 mg and 10 mg of Forest Laboratories.

Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist which is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. The product will be commercialised from Unichem’s Goa plant. Active Pharmaceutical Ingredient will also be made in house at Pithampur API plant.

Unichem Laboratories now has total of 19 ANDA approvals from US FDA.