USFDA nod to Granules India Metoprolol Succinate ER Tablets

Written by Ruchika Sharma Published On 2023-08-09T11:30:46+05:30 | Updated On 6 Oct 2023 5:08 PM IST

Telangana: Granules India has announced that the US Food & Drug Administration (US FDA) has approved the Company’s Abbreviated New Drug Application (ANDA) for Metoprolol Succinate ER Tablets 25/50/100/200 mg.

It is therapeutically equivalent to the reference listed drug, Toprol-XL Extended-Release Tablets, 25 mg, 50 mg, 100 mg and 200 mg, of Sequel Therapeutics, LLC.

The Company had filed two ANDAs for the same product with different technologies. This is the second ANDA approval for Metoprolol Succinate ER tablets that is therapeutically equivalent to the RLD, Toprol- XL, ER tablets for Granules.

Granules India Limited, incorporated in 1991 is a vertically integrated Indian pharmaceutical company headquartered at Hyderabad. The company is among the few pharmaceutical companies in the world to be present in the manufacturing of entire value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs). Its products are being distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 80+ countries with offices across India, U.S. and U.K. The Company has 8 manufacturing facilities out of which 6 are located in India and 2 are in USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.

Granules IndiaGranules India newsUSFDAMetoprolol Succinate ER TabletsToprol XL ER TabletsSequel Therapeutics

Ruchika Sharma