Granules India gets tentative nod from FDA for expectorant tablets

Hyderabad: Granules India on Thursday said the US health regulator has given its tentative approval to Guaifenesin extended-release tablets used as expectorant.

"US Food & Drug Administration (USFDA) has tentatively approved its Abbreviated New Drug Application for Guaifenesin extended-release tablets, 600 mg and 1200 mg (OTC)," the company said in a filing to the BSE.

Guaifenesin extended-release tablets, 600 mg and 1200 mg are generic equivalent of Mucinex extended-release tablets in the same strengths of RB Health (US) LLC, it added.

Guaifenesin extended-release tablets help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive.

"Being the only vertically integrated generic player for this product, Guaifenesin ER tablets is a nice addition to our growing OTC (Over The Counter) product portfolio in the US market.

"We look forward to bring this product to market upon patent expiry in April 2020," Granules Pharmaceuticals Inc ED Priyanka Chigurupati said.