Granules India gets tentative USFDA nod for generic version of Mucinex ER Tablets
New Delhi: Drugmaker Granules India Limited recently announced that the company has received tentative approval from the US Food & Drug Administration (US FDA) for Guaifenesin Extended-Release Tablets, 600 mg and 1200 mg (OTC).
Guaifenesin ER Tablets helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
The product is the generic equivalent of Mucinex ER Tablets, 600 mg and 1200 mg, of RB Health (US) LLC. Mucinex is a registered trademark of RB Health (US) LLC.
Commenting on the approval, Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals, Inc, "Being the only vertically integrated generic player for this product, Guaifenesin ER Tablets is a nice addition to our growing OTC product portfolio in the US market. We look forward to bring this product to market upon patent expiry in April 2020."
Granules now have a total of 23 ANDA approvals from US FDA (21 Final approvals and 2 tentative approvals).
The Company has 6 manufacturing facilities out of which 5 are located in India and 1 in the USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.