Date: June 26, 2026
Product Approval Update
Jubilant Generics Limited, a subsidiary of the Company's wholly-owned subsidiary Jubilant Pharma Limited, has received a tentative approval from the United States Food and Drug Administration (USFDA) for its product Pantoprazole Sodium Delayed Release Oral Suspension, 40 mg per packet.
The tentative approval is for the Solid Dosage Manufacturing Facility located at Roorkee.
The approval is subject to the expiry of the patent covering the currently listed Reference Listed Drug (RLD), which is expected to occur in December 2026. Final approval from the USFDA is anticipated upon this patent expiry.
This communication is a follow-up to an earlier disclosure dated August 2, 2025, regarding the completion of a pre-approval inspection (PAI) at the same facility.
Date of Receipt
The company received this communication on June 25, 2026, at 11:47 am.