Granules Pharmaceuticals, Inc. received US FDA approval for Ramelteon Tablets, 8 mg

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.

Shares of GRANULES INDIA LTD. was last trading in BSE at Rs.314.9 as compared to the previous close of Rs. 316.55. The total number of shares traded during the day was 170081 in over 3265 trades.

The stock hit an intraday high of Rs. 321.3 and intraday low of 311. The net turnover during the day was Rs. 53701558.

Source : Equity Bulls

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