USFDA approves Ramelteon tablets; Granules India surges

Granules India informed the bourses on Saturday that United States Food & Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) filed by its wholly-owned foreign subsidiary, Granules Pharmaceuticals, Inc (GPI) for Ramelteon tablets, 8 mg.

It is bioequivalent to the reference listed drug product (RLD), Rozerem tablets, 8 mg, of Takeda Pharmaceuticals USA, Inc. Ramelteon tablets are used for the treatment of insomnia, characterised by difficulty with sleep onset.

Granules now have a total of 29 ANDA approvals from USFDA (27 final approvals and 2 tentative approvals). Ramelteon tablets had US sales of approximately US$33 million MAT for the most recent twelve months ending in June 2020 according to IQVIA Health. Till the closure of the financial year 2020, the company had also filed 20 US drug master files (DMFs), 16 CEPs, and 7 European drug master files (EDMFs).

The stock of Granules India in today’s trading session opened gap-up at Rs 319.5 as against its previous close of Rs 314.90 and later, surged almost 3 per cent to touch an intraday high of Rs 324.70.

Granules India is a manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and finished dosages (FDs).