Granules India announces receipt of USFDA approval for Ramelteon Tablets

Granules India announced that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., a wholly owned foreign subsidiary of Granules India for Ramelteon Tablets, 8 mg. It is bioequivalent to the reference listed drug product (RLD), Rozerem Tablets, 8 mg, of Takeda Pharmaceuticals U.S.A., Inc. Ramelteon Tablets are used for the treatment of insomnia characterized by difficulty with sleep onset.

Granules now has a total of 29 ANDA approvals from US FDA (27 Final approvals and 2 tentative approvals).

Ramelteon Tablets had U.S. sales of approximately $33 million MAT for the most recent twelve months ending in June 2020 according to IQVIA Health.

Rozerem is a trademark of Takeda Pharmaceutical Company

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