Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Meropenem Injection 500 mg/vial and 1 g/vial. Aurobindo’s Meropenem injection is a generic equivalent of AstraZeneca Pharmaceuticals’ Merrem® Injection. The product will be launched immediately.
Meropenem Injection is indicated as single agent therapy for the treatment of complicated skin and skin structure infections (adult patients and pediatric patients ≥ 3 months only), complicated intra-abdominal infections such as appendicitis and peritonitis (adult patients and pediatric patients ≥ 3 months only) and bacterial meningitis (pediatric patients ≥ 3 months only). The approved product has an estimated market size of US$ 118 million for the twelve months ending January 2017 according to IMS.
This is the 1st ANDA approved out of Auronext Pharma’s (subsidiary) formulation facility in Bhiwadi, India used for manufacturing penem injectable products. Aurobindo now has a total of 314 ANDA approvals (275 Final approvals including 16 from Aurolife Pharma LLC and 39 tentative approvals) from USFDA.
