Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture Guaifenesin and Dextromethorphan Hydrobromide extended-release tablets, 600/30 mg and 1200/60mg (OTC). 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 Q1FY18.
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 $235 million for the twelve months ending December 2016, according to IRI database.
This is the 106th ANDA (including 21 tentative approvals) approved out of Unit VII formulation facility in Hyderabad, India 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.