Unichem Laboratories Receives ANDA Approval from USFDA for

Mumbai, Maharashtra, India 
Unichem Laboratories Limited is pleased to announce that it has received ANDA
approval from the United States Food and Drug Administration (U.S. FDA) for
Metronidazole USP Tablets. 
Metronidazole USP Tablets 250mg and 500mg are therapeutically equivalent to
Flagyl Tablets 250mg and 500mg of G.D Searle LLC.
Metronidazole Tablet USP is an anti-infective agent used to treat a variety of
bacterial and protozoal infections. 
The product will be commercialized from Unichem's Ghaziabad plant. Active
pharmaceutical ingredient i.e., Metronidazole used for this ANDA is also made in
house at Roha plant. 
Currently, around 6 other companies have generic approvals for the US market and
the estimated market size is over US$ 100 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.unichemlabs.com. 
Media Contact Details 
M Gundu Rao ,  Unichem Laboratories Limited ,  +91(22)66888380 , 
gundurao@unichemlabs.com 
K Subharaman ,  Unichem Laboratories Limited ,  +91(22)66888404 , 
subharamank@unichemlabs.com 
Rakesh Parikh ,  Unichem Laboratories Limited ,  +91(22)66888414 , 
rparikh@unichemlabs.com 
Monish Shah ,  Unichem Laboratories Limited ,  +91(22)66888509 , 
monish.shah@unichemlabs.com 
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-0- Jan/23/2014 12:50 GMT
 
 
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