Granules India Limited 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 version of LUMRYZ® extended-release oral suspension in the United States. The achievement marks another important milestone in the company’s strategy to expand its portfolio of complex generic medicines for regulated global markets.
This is Granules India’s second Sole First-to-File ANDA. Earlier, the company had secured the same status for Amphetamine Extended-Release Tablets, the generic equivalent of Dyanavel XR®. The latest development further strengthens the company’s capabilities in developing differentiated and complex pharmaceutical products while enhancing its position in the highly competitive US generics market.
The Sole First-to-File status provides Granules India with an opportunity to strengthen its market position once the product receives the required regulatory approvals. It also reflects the company’s growing expertise in research, product development and regulatory submissions for complex formulations.
Commenting on the achievement, Dr Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India Limited, said the Sole First-to-File status for Sodium Oxybate Extended-Release for Oral Suspension represents another significant step in the company’s complex generics journey. He said the milestone highlights the strength of Granules’ research and development and regulatory teams while supporting the company’s strategy of building a differentiated product portfolio. He added that the company remains focused on improving patient access to affordable medicines and delivering sustainable long-term growth.
The approval filing is for the generic version of LUMRYZ®, an extended-release sodium oxybate oral suspension used in the United States to treat cataplexy or excessive daytime sleepiness in patients suffering from narcolepsy. The medicine is designed to help patients manage symptoms associated with the chronic sleep disorder through an extended-release formulation.
Granules India believes the latest achievement reinforces its commitment to innovation, product differentiation and expansion in regulated pharmaceutical markets. The company continues to invest in complex generic products that offer higher value while meeting growing healthcare needs.
Established in 1991 and headquartered in Hyderabad, Granules India is a vertically integrated pharmaceutical company with operations across the entire manufacturing value chain, including Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), Finished Dosages and Peptides CDMO services. The company operates 10 manufacturing facilities across India, the United States and Switzerland and supplies products to more than 300 customers in over 80 countries. Its manufacturing sites are approved by several leading global regulatory authorities, supporting the company’s strong presence in international pharmaceutical markets.
