Granules India Limited announced today that the US Food & Drug Administration (US FDA) has tentatively approved its Abbreviated New Drug Application (ANDA) for Guaifenesin Extended-Release Tablets, 600 mg and 1200 mg (OTC), generic equivalent of Mucinex® Extended-Release Tablets, 600 mg and 1200 mg, of RB Health (US) LLC.
"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" said Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals, Inc., commenting on the approval.
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).
Mucinex® is a registered trademark of RB Health (US) LLC.
Shares of GRANULES INDIA LTD. was last trading in BSE at Rs.159.9 as compared to the previous close of Rs. 162.8. The total number of shares traded during the day was 46486 in over 703 trades.
The stock hit an intraday high of Rs. 163.6 and intraday low of 158.15. The net turnover during the day was Rs. 7462610.