Unichem Laboratories

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CORPORATE/PHARMA

Unichem Laboratories Receives ANDA Tentative Approval from USFDA for Memantine Hydrochloride Tablets


 
Unichem Laboratories Limited has announced that it has received ANDA tentative approval from the United States Food and Drug Administration (U.S. FDA) for Memantine Hydrochloride Tablets. Final approval will be received after the patent expires on April 11, 2015. 

Memantine Hydrochloride Tablets 5mg and 10mg are therapeutically equivalent to NAMENDA® Tablets 5mg and 10mg of Forest Laboratories Inc., 

Memantine Hydrochloride is used to treat moderate to severe dementia of the Alzheimer's type. Further, it reduces the actions of chemicals in the brain that may contribute to the symptoms of Alzheimer's disease. 

The product will be commercialized from Unichem’s GOA plant. Active pharmaceutical ingredient i.e. Memantine Hydrochloride used for this ANDA is also made in house at Pithampur plant. 

The market size is US$ 1.5 billion as of March, 2012 at brand price. 

About Unichem Laboratories Limited. 

Unichem Laboratories Limited is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India and several other markets across the world. In India, the company is a leader in niche therapy areas of cardiology, neurology, orthopedics and anti-infectives. The company has strong skills in product development, process chemistry and manufacturing of complex API as well as dosage forms. More information about the company can be found at www.unichemlabs.com. 

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