Aurobindo Pharma gets USFDA nod for Guaifenesin generic

Our Bureau Hyderabad | Updated on October 24, 2019

Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture Guaifenesin extended-release tablets.

Hyderabad-based Aurobindo’s Guaifenesin extended-release tablets are the AB rated generic equivalent of RB Health (US) LLC’s Mucinex tablets, according to a release. The product is expected to be launched launch in Q4FY20.

Guaifenesin extended-release tablets helps to loosen phlegm (mucus), and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. The approved product has an estimated market size of $ 301 million for the twelve months ending July 2019, according to IRI database.

This is the 10 th ANDA (including 1 tentative approval) approved out of Unit X formulation facility in Naidupet, Andhra Pradesh, India used for manufacturing oral products. Aurobindo now has a total of 419 ANDA approvals (392 Final approvals including 21 from Aurolife Pharma LLC and 27 tentative approvals) from USFDA.

Published on October 24, 2019

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