Wockhardt Receives U.S. FDA's Generic Version Of Aricept Tablets

Pharmaceutical and biotechnology major, Wockhardt received preliminary approval from the U.S. Food & Drug Administration (FDA) to market in the 5mg and 10mg of donepezil HCl tablets, used in Alzheimer's disease and dementia.

Donepezil is the generic brand name Aricept ®, marketed in the United States by Eisai in collaboration with Pfizer. Wockhardt will launch the product in the U.S. market, May 28, 2011. According to IMS Health, the total market for this product in the United States is about $ 2.5 billion.

"This is our second ANDA approval in less than a week and marks a good beginning for our fiscal year 2012," said Wockhardt Chairman Habil Khorakiwala. "We receive a steady stream of FDA approval and are able to cast to the date of the generic market opportunity opens. While the activities of existing products have grown, we have increased our growth with a constant infusion of new products."

Donepezil is a drug commonly used to treat Alzheimer's disease, whose incidence is growing rapidly throughout the world, due to the continued growth of the population.

The U.S. market for generics, Wockhardt has grown market share for its products. In many cases, Wockhardt, by virtue of being among the first on the market, harvesting has the advantage of being a participant at the beginning. Wockhardt manufactures tablets and API used in the formulation. The tablets will be manufactured at the factory of U.S. FDA certified formulation Waluj, Aurangabad and API will be manufactured at the factory API approved by the FDA in Ankleshwar, Gujarat. Both were API and tablets have been developed internally.

Wockhardt is one of the few companies with end to end integrated features to its products, starting with the manufacture of API oral and sterile dosage forms and marketing through the wholly owned subsidiary of United States, allows the company to collect the maximum value.