Granules India Ltd received ANDA Approval for Metoprolol Succinate ER Tablets

Granules India Limited today, announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended-Release Tablets USP, 25 mg, 50 mg, 100 mg and 200 mg. It is bioequivalent to the reference listed drug product (RLD), Toprol-XL Tablets, 25 mg, 50 mg, 100 mg and 200 mg, of Toprol Acquisition LLC.

Metoprolol Succinate ER Tablets are indicated for the treatment of hypertension in order to lower blood pressure.

Granules now has a total of 57 ANDA approvals from US FDA (55 final approvals and 2 tentative approvals).

The current annual U.S. market for Metoprolol Succinate ER Tablets is approximately $321Million, according to MAT Mar 2023, IQVIA/IMS Health.

Shares of Granules India Limited was last trading in BSE at Rs. 279.25 as compared to the previous close of Rs. 277.20. The total number of shares traded during the day was 30799 in over 710 trades.

The stock hit an intraday high of Rs. 280.90 and intraday low of 275.30. The net turnover during the day was Rs. 8599193.00.

Source : Equity Bulls

Keywords

GranulesIndia INE101D01020 USFDA Approval ANDA MetoprololSuccinateERTablets