Granules India rises 3% on USFDA nod to insomnia drug

NEW DELHI: Shares of Granules India climbed 3 per cent in Monday’s trade after the drug maker said its US-based subsidiary has received approval for Ramelteon tablets, which is used in the treatment of insomnia.

The United States Food & Drug Administration (USFDA), it said, has approved the abbreviated new drug application (ANDA) filed by Granules Pharmaceuticals Inc for Ramelteon tablets, 8 mg. The product is a generic version of Takeda Pharmaceuticals USA, Inc’s Rozerem tablets in the same strength, the company said.

Following the development, the stock rose 3.11 per cent to hit a high of Rs 324.70 on BSE. With this, the scrip has rallied 158 per cent so far this year and 260 per cent in the past one year. On the technical front, the scrip has been trading above its 5-day, 20-day, 50-day, 100-day and 200-day moving averages.

According to IQVIA Health data, Ramelteon tablets had US sales of around $33 million moving annual total (MAT) for the 12 months ended June 2020, Granules India said.

The tablets are used for the treatment of insomnia characterized by difficulty with sleep onset, it added.

The company now has a total of 29 ANDA approvals from USFDA (27 final approvals and 2 tentative approvals), Granules India said.