Granules India receives USFDA approval for insomnia tablets

Granules India rose 2.08% to Rs 321.45 after the US drug regulator approved the Abbreviated New Drug Application (ANDA) filed by the company's subsidiary for Ramelteon tablets.

Granules India in a regulatory filing announced that Ramelteon tablets are bioequivalents to the reference listed drug product (RLD), Rozerem tablets of Takeda Pharmaceuticals U.S.A., Inc. Ramelteon tablets are used for the treatment of insomnia characterized by difficulty with sleep onset.

Granules said has a total of 29 ANDA approvals from US FDA (27 final approvals and 2 tentative approvals). According IQVIA Health, Ramelteon Tablets had a US sales of approximately $33 million MAT for the most recent twelve months ending in June 2020.

Granules India is a growing pharmaceutical manufacturing company. It produces Finished Dosages (FDs), Pharmaceutical Formulation intermediates (PFls) and Active Pharmaceutical Ingredients (APIs) which gives the customers flexibility and choice.

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