Zydus Cadila receives tentative approval from USFDA for Amlodipine Besylate, Benazepril Hydrochloride

01 Apr 2013 Evaluate

Zydus Cadila has received tentative approval from the USFDA for Amlodipine Besylate and Benazepril Hydrochloride capsules, which fall under the anti-hypertensive drug segment. The company received US Food and Drug Administration’s (USFDA) tentative nod for the formulation in the strengths of 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg.

As per IMS, the estimated sale for Amlodipine Besylate and Benazepril Hydrochloride capsules in 2012 was $384.8 million.

The group now has 78 approvals and has so far filed 173 abbreviated new drug applications (ANDAs) since the commencement of the filing process in 2003-04.

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