ANDA Approval

Granules India Secures Sole First-to-File Status for Sodium Oxybate Generic in US

Granules India secures Sole First-to-File ANDA status for Sodium Oxybate ER, the generic equivalent of LUMRYZ, targeting the US narcolepsy treatment market.

Granules India · 6 Jul 2026, 8:37 AM IST