Granules India gets US FDA Nod For Hypertension Drug, Metoprolol Succinate ER Tablets

Granules India Limited, a vertically integrated, rapidly growing Indian pharmaceutical company, announced that the 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 Toprol-XL tablets, 25 mg, 50 mg, 100 mg, and 200 mg, manufactured by Toprol Acquisition LLC.

Metoprolol succinate ER tablets are prescribed to treat hypertension and lower blood pressure. Granules has now received 57 ANDA approvals from the US FDA (55 final approvals and two tentative approvals). According to MAT March 2023, IQVIA/IMS Health, the current annual US market for metoprolol succinate ER tablets is approximately $321 million. Granules India Limited, founded in 1991, is a vertically integrated, fast-growing Indian pharmaceutical company with best-in-class facilities and a dedication to operational excellence, quality, and customer service.