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Aurobindo Pharma Ltd has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Metronidazole tablets.
The approved Abbreviated New Drug Application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product Flagyl tablets of GD Searle LLC, the Hyderabad-based company said in a statement issued here on Monday.
Metronidazole tablets are used to treat different types of infections which are due to particular types of bacteria and some other infectious organisms, or to prevent infection during an operation.
The product has an estimated market size of US$58 million for the twelve months ending March 2015 according to IMS. The company will commence shipping shortly.
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