Granules India Ltd Share Price – NSE /  BSE

Pharmaceuticals, Small Cap

Granules India will hold a meeting of the Board of Directors of the Company on 21 July 2026.

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.

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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.

Granules India today announced that its wholly-owned subsidiary, Granules Pharmaceuticals, Inc. (GPI), located in Chantilly, Virginia, US, has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA), with a Voluntary Action Indicated (VAI) classification. The inspection was conducted from 30 March to 03 April 2026, during which four Form 483 observations were issued.