Jubilant Pharmova Subsidiary Gets Tentative USFDA Approval for Pantoprazole
Jubilant Pharmova subsidiary, Jubilant Generics, received tentative USFDA approval for Pantoprazole Sodium Delayed Release Oral Suspension. Final approval is expected upon patent expiry in December 2026.
The approval is tentative and subject to patent expiry, meaning commercialization is not immediate. However, it represents a significant step towards market entry for a new product.
The tentative USFDA approval for a new drug product is a positive development for the company's subsidiary, indicating progress in their product pipeline and market access.
Jubilant Pharmova Limited announced that its subsidiary, 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 tentative approval is contingent upon the expiry of the patent for the Reference Listed Drug (RLD), which is scheduled for December 2026. The company anticipates final approval following this patent expiry.
This development follows a pre-approval inspection (PAI) conducted by the USFDA at the Solid Dosage Manufacturing Facility in Roorkee, previously communicated on August 2, 2025.
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