Announced Fri, 26 Jun · 24:23 IST
USFDA tentative approval for Pantoprazole oral suspension
JUBLPHARMA · price
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AI summary
Jubilant Generics Limited, a step-down subsidiary of Jubilant Pharmova, has received a tentative USFDA approval for Pantoprazole Sodium Delayed Release Oral Suspension, 40 mg per packet, manufactured at its Roorkee solid dosage facility. This follows a pre-approval inspection completed earlier. The approval is tentative because it depends on the patent for the reference listed drug expiring in December 2026, after which final approval is expected.
Likely market impact
Positive long-term signal. Commercial launch likely after December 2026 patent expiry, adding a new generic product to the US pipeline.