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news.The USFDA has granted final approval to Aurobindo Pharma to produce and market Amlodipine Besylate and Benazepril Hydrochloride Capsules 2.5mg/10mg, 5mg/10mg, 5mg/20mg, 5mg/40mg, 10mg/20mg and 10mg/40mg.
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The Amlodipine Besylate and Benazepril Hydrochloride Capsules are the generic bioequivalent to the reference listed drug Lotrel Capsules of Novartis Pharmaceuticals.
The products, indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent and falls under the cardio-vascular therapeutic category, have been approved out of Unit VII (SEZ) formulations facility in Hyderabad, India.
The annual sales of Amlodipine Besylate and Benazepril Hydrochloride Capsules for the twelve months ending March 2012 is approximately $500m, according to IMS.