ANI Pharmaceuticals and Dexcel Announce FDA Approval of Donepezil Hydrochloride 23mg Tablets

ANI Pharmaceuticals, Inc. (“ANI”) (NASDAQ: ANIP) today announced that its collaboration partner Dexcel Pharma Technologies Ltd. (“Dexcel”) has received approval from the U.S. Food and Drug Administration (“FDA”) of the Abbreviated New Drug Application (“ANDA”) for Donepezil HCl 23mg Tablets. Sales of the product for calendar year 2015 were $44 million, according to IMS Health, with five current generic competitors. ANI and Dexcel expect to begin shipping to customers shortly.

Arthur S. Przybyl, President and CEO of ANI Pharmaceuticals stated, “We are excited to have achieved this milestone with Dexcel and look forward to a successful launch.”

About Donepezil 23mg Tablets

Donepezil is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s Disease.

About ANI

ANI Pharmaceuticals, Inc. (the “Company” or “ANI”) is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. The Company’s targeted areas of product development currently include narcotics, oncolytics (anti-cancers), hormones and steroids, and complex formulations involving extended release and combination products. For more information, please visit our website

About Dexcel

Dexcel Pharma is a private international specialty pharmaceutical group, dedicated to the development, manufacturing and commercialization of novel drug formulations and complex generics. Dexcel Pharma has a broad portfolio of branded and generic products, sold in more than 30 countries worldwide. Dexcel Pharma was established in 1968 and is headquartered in Israel.