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
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