Granules India bags USFDA okay for Guaifenesin and Pseudoephedrine Hydrochloride ER Tablets
Hyderabad: Granules India Limited announced today that the US Food & Drug Administration (USFDA) has approved its Abbreviated New Drug Application (ANDA) for Guaifenesin and Pseudoephedrine Hydrochloride Extended-Release (ER) Tablets, 600 mg/60 mg and 1200 mg/120 mg (OTC). It is bioequivalent to the reference listed drug product, Mucinex D Extended-Release Tablets, 600 mg/60 mg and 1200 mg/120 mg, of RB Health (US) LLC.
Guaifenesin and Pseudoephedrine Hydrochloride ER Tablets are used to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive; 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 US FDA (49 Final approvals and 2 tentative approvals). The Mucinex D brand and store brands had combined U.S. sales of approximately $71 million MAT for the most recent twelve months.
Read also: Granules India Receives Licences from MPP to Market generic of Pfizers Paxlovid
Granules India is an Indian pharmaceutical manufacturing company that was founded in 1984 named as Triton Laboratories located in Hyderabad, India.
Granules manufactures varieties of drugs including Paracetamol, Ibuprofen, Metformin, and Guaifenesin, on a large scale for customers in the domestic as well as international markets.
Read also: USFDA okays Granules Pharma Bupropion Hydrochloride ER Tablets
