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Aurobindo Pharma gets USFDA’s nod for Guaifenesin Extended-Release Tablets

Aurobindo Pharma is has received final approval from the US Food & Drug Administration (USFDA) to manufacture Guaifenesin extended-release tablets, 600 mg and 1200 mg (OTC). The company’s Guaifenesin extended-release tablets are the AB rated generic equivalent of RB Health (US) LLC’s Mucinex tablets. The product is expected to 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. According to IRI database, the approved product has an estimated market size of $ 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. The company now has a total of 419 ANDA approvals (392 Final approvals including 21 from Aurolife Pharma LLC and 27 tentative approvals) from USFDA.

Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.

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