Granules India shares rose 2.14% to ₹851 following the company's announcement of securing Sole First-to-File (FTF) status for its Abbreviated New Drug Application (ANDA) for Sodium Oxybate Extended-Release for Oral Suspension. According to Business Standard, the stock movement reflects positive investor sentiment toward the company's continued success in the U.S. generic pharmaceutical market.
According to reports from Business Standard, 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. This generic equivalent targets LUMRYZ extended-release oral suspension, representing a significant milestone for the company's U.S. market expansion strategy. The ANDA is the generic equivalent of LUMRYZ extended-release oral suspension, which is a registered trademark of Alkermes plc or its affiliates. For generic drugmakers, sole first-to-file status can be commercially significant under the US regulatory framework. An eligible first applicant that successfully challenges patents covering a branded drug may qualify for 180 days of generic market exclusivity, subject to statutory and regulatory requirements.
As reported by Business Standard, this achievement marks Granules India's second Sole First-to-File ANDA, following its earlier success with Amphetamine Extended-Release Tablets, the generic equivalent of Dyanavel XR. The company continues to demonstrate its growing capabilities in developing and advancing complex, differentiated generic products for the U.S. market, positioning itself as a key player in the specialized pharmaceutical segment. Dr. Krishna Prasad Chigurupati, Chairman & Managing Director, stated that securing Sole First-to-file status for the sodium oxybate extended release for oral suspension ANDA is another important milestone in the company's complex generics journey. He emphasized that the development reflected the company's research and development and regulatory capabilities as it seeks to build a differentiated product portfolio.
According to Business Standard, the Sole First-to-File designation further strengthens Granules India'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. The company, incorporated in 1991, operates across the pharmaceutical manufacturing chain, from active pharmaceutical ingredients and formulation intermediates to finished dosages and peptides contract development and manufacturing. It has 10 manufacturing facilities across India, the US and Switzerland and sells products in more than 80 countries, positioning it as a vertically integrated, fast-growing Indian pharmaceutical company among the few pharmaceutical companies in the world to be present across the entire manufacturing value chain.
As reported by Business Standard, LUMRYZ (sodium oxybate) extended-release oral suspension is indicated in the United States for the treatment of cataplexy or sudden loss of muscle control, and excessive daytime sleepiness in patients with narcolepsy. The product is a registered trademark of Alkermes plc or its affiliates, positioning Granules India to enter the specialized narcolepsy treatment market with its generic alternative. The filing was made through a BSE filing by the Hyderabad-based drugmaker, marking another significant step in the company's strategic push into complex generics in the U.S. market.
