Aurobindo Pharma gets USFDA nod for Guaifenesin generic
- IBEF
- October 25, 2019
Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) for production of Guaifenesin extended-release tablets.
According to a release, Aurobindo's Guaifenesin which is an extended-release tablets is the AB rated generic version that is equivalent of RB Health (US) LLC's Mucinex tablets. This is expected to be launched launch in Q4FY20.
These tablets will aid in loosening the phlegm (mucus), and thin bronchial secretions to clear the bronchial passageways of inconvenient mucus and make coughs more productive. According to IRI database, the approved product has an estimated market size of US$ 301 million for the twelve months ending July 2019.
This is the 10th ANDA (including 1 tentative approval) approved out of Unit X formulation facility in Naidupet, Andhra Pradesh, India used for manufacturing oral products. After this approval from USFDA, Aurobindo now has a total of 419 ANDA approvals (392 Final approvals including 21 from Aurolife Pharma LLC and 27 tentative approvals).
Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.
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