StockWatch
·
Pharmaceuticals
USFDA26 Jun 2026, 07:30 am

Jubilant Pharmova Unit Gets Tentative USFDA Nod for Pantoprazole Sodium DR

AI Summary

Jubilant Generics Limited, a subsidiary of Jubilant Pharma Limited, has received tentative approval from the USFDA for Pantoprazole Sodium Delayed Release Oral Suspension, 40 mg per packet. This follows a pre-approval inspection (PAI) at the Roorkee facility. The approval is contingent upon the expiry of the relevant patent, anticipated in December 2026, after which final approval is expected. This development signifies progress in the company's generic drug pipeline and its ability to secure US regulatory approvals.

Key Highlights

  • Tentative USFDA approval for Pantoprazole Sodium DR oral suspension.
  • Approval is for a 40 mg per packet formulation.
  • Subject to patent expiry in December 2026.
  • Facility located at Roorkee received pre-approval inspection.
  • Jubilant Generics is a subsidiary of Jubilant Pharma.