Unichem Laboratories receives ANDA approval for Donepezil Hydrochloride Tablets

24 Jun 2016 Evaluate

Unichem Laboratories has received ANDA approval from the United States Food and Drug Administration (USFDA) for Donepezil Hydrochloride Tablets USP. Donepezil Hydrochloride Tablets USP 5mg and 10mg are therapeutically equivalent to Aricept Tablets, 5mg and 10mg of Eisai, Inc. (USA). Donepezil Hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase which is used to improve cognition and behavior of people with Alzheimer's, but does not slow the progression of or cure the disease. 

The product will be commercialized from Unichem’s Goa plant. Active Pharmaceutical Ingredient will also be made in house at Roha API Plant. With this new approval, Unichem Laboratories has total of 21 molecules approved from USFDA.

Unichem Laboratories is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India and several other markets across the world. In India, the company is a leader in niche therapy areas of cardiology, neurology, orthopedics and anti-infectives.

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