Aurobindo Pharma gets USFDA nod for Amlodipine and Valsartan Tablets

26 Apr 2016 Evaluate

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Amlodipine and Valsartan Tablets USP, 5 mg/160 mg, 10 mg/160 mg, 5 mg/320 mg and 10 mg/320 mg. This product is expected to be launched in Q1 FY16-17.

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Exforges Tablets of Norvartis Pharmaceuticals Corporation. Amlodipine and Valsartan Tablets are used in the treatment of hypertension, to lower blood pressure. The approved product has an estimated market size of $123 million for the twelve months ending February 2016.

This is the 71st ANDA (including 15 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. Aurobindo now has a total of 254 ANDA approvals (218 Final approvals including 10 from Aurolife Pharma LLC and 36 tentative approvals) from USFDA.

Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.

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