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Granules India 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.
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.
The aforementioned ANDA is the generic equivalent of LUMRYZ extended-release oral suspension.
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.
This event marks Granules’ second sole first-to-file ANDA, following its earlier success with amphetamine extended-release tablets, the generic equivalent of Dyanavel XR.
Dr. Krishna Prasad Chigurupati, chairman & managing director, Granules India, said: '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.'
Granules India is a vertically integrated, fast-growing Indian pharmaceutical company. It is among the few pharmaceutical companies in the world to be present across the entire manufacturing value chain — from active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs) to peptides CDMO.
The company said the facility remains an important part of its global manufacturing and supply network, with continued focus on quality systems, regulatory compliance, and patient safety.
Granules India is primarily involved in the manufacturing and sale of active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs). The company’s consolidated net profit climbed 32.58% to Rs 201.56 crore on 22.81% increase in revenue from operations to Rs 1,470.60 crore in Q4 FY26 over Q4 FY25.
Divis Laboratories Ltd, Granules India Ltd, Mangalore Refinery And Petrochemicals Ltd, Alkyl Amines Chemicals Ltd are among the other stocks to see a surge in volumes on BSE today, 03 June 2026.
Concord Biotech Ltd witnessed volume of 1.68 lakh shares by 10:46 IST on BSE, a 9.35 times surge over two-week average daily volume of 17948 shares. The stock increased 6.13% to Rs.1,238.30. Volumes stood at 74467 shares in the last session.
Divis Laboratories Ltd saw volume of 1.78 lakh shares by 10:46 IST on BSE, a 7.15 fold spurt over two-week average daily volume of 24834 shares. The stock dropped 0.15% to Rs.6,518.50. Volumes stood at 16261 shares in the last session.
Granules India Ltd clocked volume of 5.05 lakh shares by 10:46 IST on BSE, a 4.59 times surge over two-week average daily volume of 1.10 lakh shares. The stock gained 1.71% to Rs.790.10. Volumes stood at 30974 shares in the last session.
Mangalore Refinery And Petrochemicals Ltd registered volume of 8.35 lakh shares by 10:46 IST on BSE, a 3.76 fold spurt over two-week average daily volume of 2.22 lakh shares. The stock rose 4.11% to Rs.153.25. Volumes stood at 1.53 lakh shares in the last session.
Alkyl Amines Chemicals Ltd witnessed volume of 48669 shares by 10:46 IST on BSE, a 3.25 times surge over two-week average daily volume of 14986 shares. The stock increased 1.11% to Rs.1,806.40. Volumes stood at 84431 shares in the last session.
Granules India Ltd, Usha Martin Ltd, JK Tyre & Industries Ltd, Exide Industries Ltd are among the other stocks to see a surge in volumes on NSE today, 27 May 2026.
AIA Engineering Ltd recorded volume of 9.88 lakh shares by 14:14 IST on NSE, a 19.58 times surge over two-week average daily volume of 50441 shares. The stock gained 6.00% to Rs.4,391.80. Volumes stood at 2.41 lakh shares in the last session.
Granules India Ltd saw volume of 106.42 lakh shares by 14:14 IST on NSE, a 15.18 fold spurt over two-week average daily volume of 7.01 lakh shares. The stock increased 4.03% to Rs.787.00. Volumes stood at 7.36 lakh shares in the last session.
Usha Martin Ltd recorded volume of 51.5 lakh shares by 14:14 IST on NSE, a 12.63 times surge over two-week average daily volume of 4.08 lakh shares. The stock gained 6.14% to Rs.510.30. Volumes stood at 5.17 lakh shares in the last session.
JK Tyre & Industries Ltd saw volume of 111.59 lakh shares by 14:14 IST on NSE, a 10 fold spurt over two-week average daily volume of 11.15 lakh shares. The stock increased 5.23% to Rs.414.75. Volumes stood at 15.73 lakh shares in the last session.
Exide Industries Ltd recorded volume of 212.15 lakh shares by 14:14 IST on NSE, a 8.93 times surge over two-week average daily volume of 23.75 lakh shares. The stock gained 7.52% to Rs.393.80. Volumes stood at 73.52 lakh shares in the last session.