Unichem Laboratories Receives ANDA Approval from USFDA for

Mumbai, Maharashtra, India, Thursday, November 29, 2012 -- (Business Wire India) 
Unichem laboratories Limited are pleased to announce that it has received ANDA
approval from the United States Food and Drug Administration (U.S. FDA) for
Tizanidine Tablets.  
Tizanidine Tablets USP 2mg and 4mg are therapeutically equivalent to ZANAFLEX®
Tablets 2mg and 4mg from Acorda Therapeutics.  
Tizanidine tablets belong to a group of medicines called skeletal muscle
relaxants. Tizanidine Tablets is used to help relieve, although not cure, muscle
spasms caused by medical conditions such as multiple sclerosis or injuries to
the brain or spine. 
The product will be commercialized from Unichem's Goa plant. Active
pharmaceutical ingredient i.e., Tizanidine Hydrochloride used for this ANDA is
also made in house at Roha plant.  
Currently, there are 9 generic approvals, while only 3 companies are dominating
the market. The current market size is US$ 70 Million growing at 5% in value
terms and 10% in volume. 
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 (22) 66888404 / +91 9833031121,
Mr. Rakesh Parikh,
Unichem Laboratories Limited,
+91 (22) 66888414 / +91 9892925555,
Mr. M Gundu Rao,
Unichem Laboratories Limited,
+91 (22) 66888380 / +91 9820228944,
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-0- Nov/29/2012 11:46 GMT
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