Unichem Laboratories Limited has received ANDA approval from the US Food and Drug Administration (FDA) for donepezil hydrochloride tablets (5 mg and 10 mg), which are therapeutically equivalent to Eisai Inc’s Aricept tablets.
Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase which is used to improve cognition and behaviour of people with Alzheimer’s, but does not slow the progression of or cure the disease. While the product will be commercialised from Unichem’s Goa plant, the active pharmaceutical ingredient (API) will be made in house at Roha API plant. Unichem Laboratories Limited now has total of 21 molecules approved from US FDA.
