Aurobindo Pharma, the market leader in semi-synthetic penicillin drugs has received approval from the US Food & Drug Administration (USFDA) for its tentatively approved ANDA for Donepezil Hydrochloride Tablets 5mg and 10mg.
Donepezil Hydrochloride Tablets 5mg and 10mg is the generic equivalent to Aricept Tablets 5mg and 10mg of Eisai Medical Research Inc. Donepezil Hydrochloride Tablets are indicated for the treatment of mild, moderate, and severe dementia of the Alzheimer's type and fall under the central nervous system (CNS) therapeutic segment. The product will be launched soon which has a market size of approximately $2.5 billion for the twelve months ending September 2010 according to IMS.
The company now has a total of 136 ANDA approvals (106 Final approvals and 30 tentative approvals) from USFDA.
Aurobindo Pharma, headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, ANVISA Brazil.
