Unichem Laboratories Limited is pleased to announce that it 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 acetylcholine sterase 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.
Unichem Laboratories Limited now has total of 21 molecules approved from USFDA.
About Unichem Laboratories Limited
Unichem Laboratories Limited 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. The company has strong skills in product development, process chemistry and manufacturing of complex API as well as dosage forms. More information about the company can be found atwww.unichemlabs.com