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Ahmedabad-based drug major Cadila Healthcare (popularly known as Zydus Cadila) has received tentative approval from the US drug regulator 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, the company said in a statement here.
It also added that the estimated sales for Amlodipine Besylate and Benazepril Hydrochloride capsules in 2012 as per IMS was $384.8 million (around Rs 2,088.69 crore).
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.
Earlier this year, Zydus received USFDA's final approval to market Pioglitazone HCI tablets in US, an anti-diabetics drug, which has an estimated market size of $2 billion (Rs 10,856 crore).
