Unichem Gets USFDA Nod For Its Donepezil Hydrochloride Tablets


New Delhi: Drug firm Unichem Laboratories has received approval from the US health regulator for it’s Donepezil Hydrochloride tablets used for improving cognition and behaviour of people suffering with Alzheimer’s disease.

The company has “received abbreviated new drug application (ANDA) approval from the United States Food and Drug Administration (USFDA) for Donepezil Hydrochloride tablets USP,” Unichem Laboratories said in a filing to BSE.

The company’s product in the strengths of 5mg and 10mg is generic version of Eisai Inc’s Aricept tablets in the same strengths, it added.

“The product will be commercialised from Unichem’s Goa plant. Active Pharmaceutical Ingredient will also be made in house at Roha API plant,” Unichem Laboratories said.

Donepezil Hydrochloride is used to improve cognition and behavior of people with Alzheimer’s, but does not slow the progression of or cure the disease, it added.

The company currently has total of 21 molecules approved from USFDA, Unichem Laboratories said.

Shares of Unichem Laboratories were trading 2.26 per cent down at Rs 265.95 ascrip on BSE.