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via thehindubusinessline.comBusiness & Companies

Granules India seeking first-to-file status for Ruxolitinib Extended-Release Tablets

FROM THE WIRE · THEHINDUBUSINESSLINE.COM

Granules India seeks first-to-file status for Ruxolitinib Extended-Release Tablets, potentially securing 180 days of US generic exclusivity pending FDA review.

Read at the source ↗
MARKET IMPACTNEUTRAL✦ News Impact agent estimateTone: expected bullishPotential 180-day US generic exclusivity could support future company growth.AI-generated summary
✦ IN BRIEF · AIAI-generated summary
  1. 01Granules India seeks first-to-file status for Ruxolitinib Extended-Release Tablets.
  2. 02Approval would grant 180 days of US generic exclusivity.
  3. 03FDA review decision is still pending for this formulation.

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