Granules India gets USFDA nod to insomnia drug Ramelteon
Ramelteon Tablets are used for the treatment of insomnia characterized by difficulty with sleep onset.
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.
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 Limited.
Read also: Granules India Clarifies On Recall Of 4.78 Lakh Bottles Of Metformin Hydrochloride ER Tablets In US
Granules India is an Indian pharmaceutical manufacturing company which was founded in 1984 named as Triton Laboratories located in Hyderabad, India.
Granules manufactures varieties of drugs including Paracetamol, Ibuprofen, Metformin and Guaifenesin, on a large scale for customers in the domestic as well as international markets.
Granules has seven manufacturing facilities; six are in India while the seventh is through a joint venture with Hubei Bio case in Wuhan, China along with two research centres, at Hyderabad and Pune.
Read also: Granules India Net Profit Up 34 Percent To Rs 111.4 Crore In Q1
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