Granules India Ltd received ANDA Approval for Guaifenesin and Pseudoephedrine Hydrochloride Extended-Release Tablets

Granules India Limited announced today that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Guaifenesin and Pseudoephedrine Hydrochloride Extended-Release (ER) Tablets, 600 mg/60 mg and 1200 mg/120 mg (OTC). It is bioequivalent to the reference listed drug product, Mucinex D Extended-Release Tablets, 600 mg/60 mg and 1200 mg/120 mg, of RB Health (US) LLC.

Guaifenesin and Pseudoephedrine Hydrochloride ER Tablets are used to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive; temporarily relieve nasal congestion due to common cold, hay fever, upper respiratory allergies; temporarily restores freer breathing through the nose; promotes nasal and/or sinus drainage; and temporarily relieves sinus congestion and pressure.

Granules now have a total of 51 ANDA approvals from US FDA (49 Final approvals and 2 tentative approvals).

The Mucinex®️ D brand and store brands had combined U.S. sales of approximately $71 million MAT for the most recent twelve months.

Shares of Granules India Limited was last trading in BSE at Rs. 306.50 as compared to the previous close of Rs. 308.75. The total number of shares traded during the day was 53955 in over 1546 trades.

The stock hit an intraday high of Rs. 314.90 and intraday low of 305.85. The net turnover during the day was Rs. 16656274.00.

Source : Equity Bulls

Keywords

GranulesIndia INE101D01020 USFDA ANDAApproval Guaifenesin PseudoephedrineHydrochloride