Granules India bags USFDA okay for Guaifenesin and Pseudoephedrine Hydrochloride ER Tablets

Published On 2022-08-26 10:00 GMT | Update On 2022-08-26 10:01 GMT

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.

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.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Granules India bags USFDA okay for Guaifenesin and Pseudoephedrine Hydrochloride ER Tablets

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