Granules India has secured Sole First-to-File (FTF) status for its Abbreviated New Drug Application (ANDA) for Sodium Oxybate Extended-Release for Oral Suspension. It is the generic equivalent of LUMRYZ extended-release oral suspension. The development further demonstrates the company’s growing capabilities in developing and advancing complex, differentiated generic products for the U.S market.
The Sole First-to-File designation further strengthens the company’s position in the complex generics segment and underscores the company’s continued focus on innovation, execution excellence, and strategic portfolio expansion in regulated markets. LUMRYZ (sodium oxybate) extended-release oral suspension is indicated in the United States for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy. LUMRYZ is a registered trademark of Alkermes plc or its affiliates.
Granules India is 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).
