Jubilant Pharmova Secures USFDA Tentative Nod for Generic Pantoprazole Oral Suspension
New Delhi: Jubilant Pharmova Limited has informed the stock exchanges that Jubilant Generics Limited, a subsidiary of the company's wholly owned subsidiary Jubilant Pharma Limited, has received tentative approval from the United States Food and Drug Administration (USFDA) for Pantoprazole Sodium Delayed Release Oral Suspension, 40 mg per packet.
According to the filing, the latest regulatory milestone is in continuation of the company's earlier communication dated August 2, 2025, regarding the successful completion of the Pre-Approval Inspection (PAI) conducted by the USFDA at the Solid Dosage Manufacturing Facility located in Roorkee. The company stated that the tentative approval has been granted for Pantoprazole Sodium Delayed Release Oral Suspension, 40 mg per packet.
Jubilant Pharmova further informed that the tentative approval remains subject to the expiry of the patent covering the currently listed Reference Listed Drug (RLD). According to the company, the relevant patent is expected to expire in December 2026, following which the company anticipates receiving final approval from the USFDA.
The company also disclosed that it received the tentative approval from the USFDA on June 25, 2026, at 11:47 a.m.According to the regulatory filing submitted by Jubilant Pharmova, Jubilant Generics Limited has received USFDA tentative approval for Pantoprazole Sodium Delayed Release Oral Suspension, 40 mg per packet, following the earlier successful completion of the Pre-Approval Inspection at its Roorkee manufacturing facility. The company expects to obtain final approval after the expiry of the patent protecting the reference listed drug in December 2026.
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