Unichem Laboratories Receives ANDA Approval from USFDA for

Mumbai, Maharashtra, India, Thursday, October 24, 2013 -- (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
Amlodipine Besylate Tablets.  
Amlodipine Besylate Tablets USP 2.5mg, 5mg and 10mg are therapeutically
equivalent to NORVASC® Tablets 2.5mg, 5mg and 10mg from Pfizer Inc.  
Amlodipine Besylate Tablet USP is a calcium channel blocker indicated for the
treatment of hypertension, to lower blood pressure. Lowering blood pressure
reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes
and myocardial infarctions. 
The product will be commercialized from Unichem's Goa plant. Active
pharmaceutical ingredient i.e., Amlodipine Besylate used for this ANDA is also
made in house at Roha plant.  
Currently, there are 6-7 companies are dominating the US market. The current
market size is around US$ 45~50 Million. 
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 leaded in
niche areas of cardiology, neurology and other orthopadics and anti-infective.
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  
Media contact details 
M Gundu Rao,
Unichem Laboratories Ltd,
+91-22-66888 380,
Rakesh Parikh,
Unichem Laboratories Ltd,
+91-22-66888 414,
K Subharaman,
Unichem Laboratories Ltd,
+91-22-66888 404,
Mr. Monish Shah,
Unichem Laboratories Ltd,
+91-22-66888 509,
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-0- Oct/25/2013 05:38 GMT
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