Granules India Limited Secures Sole First-to-File ANDA Status for Sodium Oxybate Extended-Release for Oral Suspension

Granules India Limited announced that it has secured Sole First-to-File (FTF) status for its Abbreviated New Drug Application (ANDA) for Sodium Oxybate Extended-Release for Oral Suspension, the generic equivalent of LUMRYZ® extended-release oral suspension.

This achievement marks Granules' second Sole First-to-File ANDA, following its earlier success with Amphetamine Extended-Release Tablets, the generic equivalent of Dyanavel XR®, and further demonstrates the company's growing capabilities in developing and advancing complex, differentiated generic products for the U.S market.

"Securing Sole First-to-File status for our Sodium Oxybate Extended Release for Oral Suspension ANDA is another important milestone in our complex generics journey. This achievement reflects the strength of our R&D and regulatory capabilities, while reinforcing our commitment to building a differentiated portfolio. We remain focused on expanding patient access to affordable treatment options and delivering sustainable long-term growth." - Dr. Krishna Prasad Chigurupati, Chairman & Managing Director, Granules India Limited.

The Sole First-to-File designation further strengthens Granules 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.

Shares of Granules India Limited was last trading in BSE at Rs. 854.40 as compared to the previous close of Rs. 833.15. The total number of shares traded during the day was 86009 in over 3916 trades.

The stock hit an intraday high of Rs. 865.00 and intraday low of 834.95. The net turnover during the day was Rs. 73265819.00.

Source : Equity Bulls

Keywords

GranulesIndia INE101D01020 Pharmaceuticals FTFStatus