Unichem Laboratories Receives ANDA Tentative Approval from USFDA

Mumbai, Maharashtra, India, Friday, October 26, 2012 -- (Business Wire India) 
Unichem laboratories Limited are pleased to announce 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. 
BSE: 506690; NSE: UNICHEMLAB; Reuters: UNLB.BO; Bloomberg: UN@IN 
Media contact details 
Mr. K Subharaman,
Unichem Laboratories Limited,
+91 9833031121 / +91 (22) 66888404,
subharamank@unichemlabs.com 
Mr. Rakesh Parikh,
Unichem Laboratories Limited,
+91 9892925555 / +91 (22) 66888414,
rparikh@unichemlabs.com 
Mr. M Gundu Rao,
Unichem Laboratories Limited,
+91 9820228944 / +91 (22) 66888380,
gundurao@unichemlabs.com 
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-0- Oct/29/2012 04:50 GMT