Aurobindo Pharma receives final approval from USFDA for Ertapenem Injection

26 Jun 2018 Evaluate

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Ertapenem Injection 1 g/vial. Aurobindo’s Ertapenem injection is a generic equivalent of Merck Sharp & Dohme Corp’s Invanz Injection. The product will be launched in July 2018.

The approved product has an estimated market size of $387 million for the twelve months ending April 2018 according to IQVIA. Ertapenem injection is used for the treatment of moderate to severe infections caused by susceptible bacteria. Also indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery.

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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