USFDA approval for skin infection drug by Aurobindo Pharma

The company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Meropenem injection.

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Aurobindo Pharma Limited is a pharmaceutical manufacturing company dealing with generic pharmaceuticals and active pharmaceutical ingredients. The company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Meropenem injection.

This drug is used for treating a number of bacterial infections such as skin infections, appendicitis, peritonitis and meningitis.

The meropenem injection by Aurobindo is a generic equivalent of Merrem manufactured by AstraZeneca Pharmaceuticals.

The product will be launched in April 2017 with an estimated market size of $ 118 million this year.

This is the first Abbreviated New Drug Application (ANDA) approved out of Auronext Pharma's formulation facility in Bhiwadi, used for manufacturing penem injectable products. Aurobindo has 275 final ANDA approvals, including 16 from Aurolife Pharma LLC and 39 tentative approvals from USFDA.

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