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.
