Granules India gets tentative approval from USFDA for Guaifenesin ER Tablets

13 Feb 2020 Evaluate

Granules India has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Guaifenesin Extended-Release (ER) Tablets, 600 mg and 1200 mg (OTC), generic equivalent of Mucinex Extended-Release Tablets, 600 mg and 1200 mg, of RB Health (US) LLC. Guaifenesin ER Tablets helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Granules now has a total of 23 ANDA approvals from US FDA (21 Final approvals and 2 tentative approvals).

Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).

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