Granules India gets USFDA nod for Guaifenesin ER tablets
Granules India informed the bourses on Thursday that the company received tentative approval for its Abbreviated New Drug Application (ANDA) from US Food and Drug Administration (USFDA) for Guaifenesin Extended-release tablets, 600 mg and 1,200 mg.
The approved drug is the generic equivalent of Mucinex Extended-release tablets, 600 mg and 1,200 mg of RB Health (US), and is used to help loosen phlegm and thin bronchial secretions to rid the bronchial passageways.
Commenting on the approval, Priyanka Chigurupati, Executive Director of Granules Pharmaceuticals stated that the drug was a nice addition to the company's growing Over the Counter (OTC) product portfolio in US market and it looked forward to bring this product to market upon patent expiry in April 2020.
Granules India is a pharmaceutical company, having a presence across the pharmaceutical manufacturing value chain, including Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediaries (PFIs) and Finished Dosages (FDs). The company now has a total of 23 ANDA approvals from USFDA, including 21 Final approvals and 2 tentative approvals.
On Thursday, the stock closed at Rs 169.85, up by 6.59 per cent or Rs 10.50 per share. The 52-week high is recorded at Rs 171 and the 52-week low is Rs 84.25 on BSE.