Aurobindo Pharma Ltd has received final approval from the US Food and Drug Administration (US FDA) to manufacture and market galantamine tablets USP 4mg, 8mg and 12mg.
 
Galantamine tablets USP 4mg, 8mg and 12mg is the generic version of Ortho McNeil Janssen Pharmaceutical Inc’s Razadyne tablets 4mg, 8mg and 12mg. The product falls under the neurological (CNS) therapeutic category and is indicated for the treatment of mild to moderate dementia of the Alzheimer's type. The product has a market size of approximately US$ 41 million for the twelve months ending September 2010 according to IMS and will be launched shortly.
 
The Hyderabad-based company now has a total of 133 ANDA approvals, including 101 final approvals and 32 tentative approvals, from US FDA