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Granules India rose 2.14% to Rs 851 after the company said 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 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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