Granules India gets USFDA’s nod for Metoprolol Succinate ER Tablets

08 Aug 2023 Evaluate

Granules India has received US Food & Drug Administration (USFDA) approval for the ANDA filed 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 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).

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