Unichem Laboratories Receives ANDA Tentative Approval from USFDA

Mumbai, Maharashtra, India, Wednesday, October 17, 2012 -- (Business Wire India) 
Unichem laboratories Limited is pleased to announce that it has received ANDA
tentative approval from the United States Food and Drug Administration (U.S.
FDA) for Irbesartan . Final approval will be received after the patent expires
on Dec 7, 2015.  
Irbesartan Tablets 75mg, 150mg and 300mg are therapeutically equivalent to
AVAPRO® Tablets 75mg, 150mg and 300mg from Sanofi Aventis US, LLC.  
Irbesartan is indicated for the treatment of hypertension. It may be used alone
or in combination with other antihypertensive agents.  
The product will be commercialized (after the final approval) from Unichem's
Ghaziabad plant. Active pharmaceutical ingredient i.e. Irbesartan used for this
ANDA is also made in house at Pithampur plant.  
The current market size is US$ 450 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 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.unichemindia.com . 
BSE: 506690; NSE: UNICHEMLAB; Reuters: UNLB.BO; Bloomberg: UN@IN 
Media contact details 
Mr. K Subharaman,
+91 (22) 66888404/ +91 9833031121,
subharamank@unichemindia.com 
Mr. Rakesh Parikh,
+91 (22) 66888414/ +91 9892925555,
rparikh@unichemindia.com 
Mr. M Gundu Rao,
+91 (22) 66888380/ +91 9820228944,
gundurao@unichemindia.com 
Contributed via: Bloomberg Publisher WEB Service 
Provider ID: 7c6c982146534accbc572438c625d9f9 
-0- Oct/18/2012 05:01 GMT
 
 
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