Aurobindo Pharma gets final USFDA approval

Aurobindo Pharma Limited said it received final approval from the US Food and Drug Administration (USFDA) to manufacture Guaifenesin and Dextromethorphan Hydrobromide extended-release tablets, 600/30 mg and 1200/60mg (OTC) and the drug will be launched during the next quarter.

"Aurobindo's Guaifenesin and Dextromethorphan Hydrobromide extended-release tablets are the AB rated generic equivalent of Reckitt Benckiser's Mucinex DM tablets. The product will be launched in Q1 FY18 (in US)," it said.

Guaifenesin and Dextromethorphan Hydrobromide extended-release tablets helps loosen mucus and phlegm, and thin out bronchial secretions, making coughs more productive.

The approved product has an estimated market size of USD 235 million for the twelve months ending December 2016, Aurobindo said citing market research reports.

This is the 106th ANDA (including 21 tentative approvals) approved out of Unit VII formulation facility in Hyderabad, used for manufacturing oral products.

Aurobindo now has a total of 311 ANDA approvals (272 Final approvals including 16 from Aurolife Pharma LLC and 39 tentative approvals) from USFDA.