Granules India gets USFDA nod to insomnia drug Ramelteon
Ramelteon Tablets are used for the treatment of insomnia characterized by difficulty with sleep onset.;
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Hyderabad: Drugmaker Granules India has recently 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 Limited 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.
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