Granules India gets USFDA approval for Guaifenesin and Pseudoephedrine Hydrochloride Extended-Release Tablets

26 Aug 2022 , 12:34 PM

Granules India Limited announced on Friday that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Guaifenesin and Pseudoephedrine Hydrochloride Extended-Release (ER) Tablets, 600 mg/60 mg and also 1200 mg/120 mg (OTC). It is bioequivalent to the reference listed drug product i.e Mucinex D Extended-Release Tablets, 600 mg/60 mg and 1200 mg/120 mg also, of RB Health (US) LLC.

Guaifenesin and Pseudoephedrine Hydrochloride ER Tablets are basically used to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. It uses for temporarily relieve nasal congestion due to common cold, hay fever, upper respiratory allergies; temporarily restores freer breathing through the nose; promotes nasal and/or sinus drainage; and temporarily relieves sinus congestion and pressure.

Granules now have a total of 51 ANDA approvals from USFDA which includes 49 Final approvals and 2 tentative approvals.

The Mucinex D brand and store brands had total U.S. sales of approximately $71 million MAT for the most recent 12 months.

At around 12:36 PM, Granules India Ltd is currently trading at Rs309.75 per share up by Rs3.25 or 1.06% from its previous closing of Rs306.50 per share on the BSE.

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