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7 July 2026

Granules India drug approval

This news highlights the progress of the Indian pharmaceutical industry in securing international drug approvals, which serves as relevant context for discussions on India's achievements in science and technology and its role as the pharmacy of the world.

1 min read 1 questions 1 prelims

Notes

  • Granules India received sole first-to-file (FTF) status for an Abbreviated New Drug Application (ANDA).
  • The drug is Sodium Oxybate extended-release for oral suspension, a generic equivalent to Lumryz ER.
  • Lumryz ER is indicated for treating excessive daytime sleepiness in patients with narcolepsy.
  • This marks the second sole FTF ANDA secured by Granules India.

Questions

  1. Discuss the significance of 'First-to-File' (FTF) status in the context of the generic pharmaceutical industry and its role in enhancing access to affordable healthcare. 150 words
    Attempt this โ€” 150 words in 8 min
    0 / 150 words 8:00

Prelims

  1. In the context of the pharmaceutical industry, what does an Abbreviated New Drug Application (ANDA) primarily facilitate?