Live
- Centre of Excellence to be set up at KSRM
- Laureus Sports Awards: Djokovic, Bonmati win top honours
- ‘Aa Okkati Adakku’ Trailer: Allari Naresh and Faria Abdullah create comedy chaos, promise a hilarious ride
- Stoinis' maiden IPL ton propels LSG to 6-wkt win over CSK
- Pant's captaincy under lens as DC eye improved bowling vs GT
- NBK109: Bobby Deol Joins the Cast of Nandamuri Balakrishna’s Upcoming Film
- Sreeja surpasses Manika as India No.1 TT player
- Indian chess body AICF mulls hosting world title match between Gukesh and China's Ding
- Vijay Deverakonda's Big-Hearted Gesture, Attends Bodyguard's Wedding with Family
- Welfare schemes will be doubled if YSRCP wins again: Bhumana
Granules India gets tentative nod from FDA for expectorant tablets
Granules India on Thursday said the US health regulator has given its tentative approval to Guaifenesin extended-release tablets used as expectorant.
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.
