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Aurobindo Pharma Ltd has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Meropenem injection.
Aurobindo’s Meropenem injection is a generic equivalent of AstraZeneca Pharmaceuticals’ Merrem injection. The product will be launched in April 2017, according to a release issued here on Tuesday.
Meropenem injection is indicated as single agent therapy for the treatment of complicated skin and skin structure infections.
The approved product has an estimated market size of $ 118 million for the 12 months ended January 2017, according to IMS.
This is the 1st ANDA approved out of Auronext Pharma’s (wholly owned subsidiary) formulation facility in Bhiwadi, used for manufacturing penem injectable products. Aurobindo now has 314 ANDA approvals (275 final approvals, including 16 from Aurolife Pharma LLC and 39 tentative approvals) from USFDA.
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