Granules India has received approval from the US Food & Drug Administration (USFDA) for 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 USFDA (55 final approvals and 2 tentative approvals). The current annual U.S. market for Metoprolol Succinate ER Tablets is approximately $321 million, according to MAT March 2023, IQVIA/IMS Health.
Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).
