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Granules India has secured sole First-to-File (FTF) status for its ANDA for Sodium Oxybate

ICICIdirect Research 07 Jul 2026 DISCLAIMER

News: Granules India has secured sole First-to-File (FTF) status for its ANDA for Sodium Oxybate Extended-Release Oral Suspension, the generic equivalent of Lumryz. This marks the company's second sole FTF ANDA, following its earlier success with the generic version of Dyanavel XR. The product is indicated for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy. 

View: Although the company has not shared granular details such as manufacturing site, overall US market size, strengths for approval etc, we believe this could be a decent opportunity at least from margins perspective. We will get some more insights about this opportunity in Q1FY27 earnings call.

Impact: Positive

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