Jubilant Pharmova Limited announced that its subsidiary, Jubilant Pharma Limited, has received a tentative approval from the United States Food and Drug Administration (USFDA). The approval is for Pantoprazole Sodium Delayed Release Oral Suspension, 40 mg per packet. This development follows a pre-approval inspection (PAI) at the company’s Roorkee facility. The tentative approval is contingent on the expiry of the patent for the Reference Listed Drug, expected in December 2026.
USFDA Tentative Approval Secured
Jubilant Pharmova Limited is pleased to announce a significant milestone for its subsidiary, Jubilant Pharma Limited. Following a pre-approval inspection (PAI) conducted by the United States Food and Drug Administration (USFDA) at the Solid Dosage Manufacturing Facility in Roorkee, a tentative approval has been granted. This approval pertains to the product Pantoprazole Sodium Delayed Release Oral Suspension, 40 mg per packet.
Key Details of the Approval
The tentative approval from the USFDA marks a crucial step towards market entry for this product. It is important to note that this approval is subject to the expiry of the patent covering the currently listed Reference Listed Drug (RLD). This patent is anticipated to expire in December 2026. Jubilant Pharmova expects final approval to be granted upon the expiration of this patent, paving the way for commercialization.
Communication Timestamp
The receipt of this notification was recorded on June 25, 2026, at 11:47 AM.
Source: BSE
