Granules India Limited Secures Sole First-to-File ANDA Status for Sodium Oxybate Generic Equivalent
Hyderabad, India – Granules India Limited has secured the Sole First-to-File (FTF) status for its Abbreviated New Drug Application (ANDA) targeting Sodium Oxybate Extended-Release for Oral Suspension. This product is the generic equivalent of LUMRYZ® extended-release oral suspension.This achievement marks Granules' second instance of securing a Sole First-to-File ANDA, following a previous success with Amphetamine Extended-Release Tablets, which are the generic equivalent of Dyanavel XR®. The designation highlights the company's increasing capacity in developing and advancing specialized generic products for the U.S. market.
Dr. Krishna Prasad Chigurupati, Chairman & Managing Director of Granules India Limited, stated that securing the Sole First-to-File status for the Sodium Oxybate Extended Release for Oral Suspension ANDA is a major milestone in their complex generics journey. He added that this achievement reflects the strength of the company's R&D and regulatory capabilities, reinforcing its commitment to building a differentiated portfolio and expanding patient access to affordable treatment options while delivering sustainable long-term growth.
The Sole First-to-File designation further strengthens Granules' position within the complex generics segment, underscoring 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 treating cataplexy or excessive daytime sleepiness in patients with narcolepsy. The product is a registered trademark of Alkermes plc or its affiliates.
GRANULES Stock Price Movement
On Friday, Granules India Limited shares edged higher, finishing at ₹833.80 after gaining 0.77% against the close. The stock saw a strong trading session, hitting its year high during intraday activity and concluding with 1.3 million shares traded.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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