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12 November, 2019 13:58 IST
Aurobindo Pharma receives USFDA approval for Ertapenem injection
Source: IRIS | 26 Jun, 2018, 09.36AM
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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 USD 387 million for the twelve months ending Apr 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.

This ANDA is approved out of Auronext Pharma's (wholly owned subsidiary) formulation facility in Bhiwadi, India used for manufacturing penem injectable products. Aurobindo now has a total of 371 ANDA approvals (338 Final approvals including 17 from Aurolife Pharma LLC and 33 tentative approvals) from USFDA.

Shares of the company gained Rs 10.35, or 1.7%, to trade at Rs 618.05. The total volume of shares traded was 25,762 at the BSE (9.22 a.m., Tuesday).

Aurobindo Pharma Limited   (Q,N,C,F)*

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