Granules India Limited announced through a press release 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. This product is the generic equivalent of LUMRYZ® extended-release oral suspension.
This achievement represents Granules' second Sole First-to-File ANDA, following its earlier success with Amphetamine Extended-Release Tablets, which is the generic equivalent of Dyanavel XR®. The company stated this demonstrates its growing capabilities in developing and advancing complex, differentiated generic products for the U.S. market.
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.
Dr. Krishna Prasad Chigurupati, Chairman & Managing Director of Granules India Limited, commented: "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."
The company emphasized that this designation strengthens its position in the complex generics segment and underscores its continued focus on innovation, execution excellence, and strategic portfolio expansion in regulated markets.
Company Background
Granules India Limited, incorporated in 1991, is a vertically integrated pharmaceutical company headquartered in Hyderabad. The company has a presence across the entire manufacturing value chain including Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), Finished Dosages (FDs), and Peptides CDMO. Products are distributed to more than 300 customers across regulated and semi-regulated markets, with a global presence extending to over 80 countries. The company has 10 manufacturing facilities (seven in India, two in the US, and one in Switzerland) with regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC, and HALAL.
Disclosure Information
This disclosure was made to the National Stock Exchange of India Limited and BSE Limited. The press release was signed by Chaitanya Tummala, Company Secretary & Compliance Officer of Granules India Limited.
Safe Harbor Statement
The document includes a standard safe harbor statement noting that the information is based on estimates and for general information purposes only. It contains forward-looking statements subject to risks and uncertainties including general economic conditions, ability to implement strategy, research and development efforts, growth plans, technological changes, currency fluctuations, interest rate changes, regulatory changes, and increasing competition.