Jubilant Pharmova Subsidiary Receives USFDA Tentative Approval for Pantoprazole Oral Suspension

Jubilant Pharmova Ltd has received a tentative approval from the US Food and Drug Administration (USFDA) for Pantoprazole Sodium Delayed Release Oral Suspension, 40 mg per packet.  

The approval has been granted to Jubilant Generics Limited, a subsidiary of Jubilant Pharma Limited, which is wholly owned by Jubilant Pharmova. The company disclosed the development through a stock exchange filing on June 26, 2026. 

Final Approval to Follow Patent Expiry 

The company noted the approval is not final as the reference medicine continues to be protected by a patent in the United States.  

According to the filing, the patent for the Reference Listed Drug (RLD) is expected to expire in December 2026. Jubilant Pharmova said final approval is expected after the patent period ends, subject to regulatory requirements. 

Roorkee Plant Part of Regulatory Process 

The product is manufactured at the company's solid dosage facility in Roorkee, Uttarakhand. In August 2025, Jubilant Pharmova had informed the exchanges that the USFDA had completed a pre-approval inspection of the facility.  

The latest approval follows that inspection and relates to the same abbreviated new drug application submitted for the US market. 

Drug Used to Treat Acid-Related Conditions 

Pantoprazole is prescribed to reduce excess stomach acid and is used in the treatment of gastroesophageal reflux disease (GERD), erosive oesophagitis and other acid-related gastrointestinal disorders.  

The delayed-release oral suspension is intended for patients who require an oral suspension instead of conventional tablet formulations. 

Company Informs Stock Exchanges 

Jubilant Pharmova said it received the USFDA communication on June 25, 2026. The information was subsequently shared with the BSE and the NSE  under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The filing was signed by Company Secretary Naresh Kapoor. 

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Jubilant Pharmova Share Price Performance  

As of June 25, 2026, 3:30 pm, Jubilant Pharmova Ltd share price closed at ₹964.00, 0.90% down from the previous closing price. 

Conclusion 

The tentative approval allows Jubilant Pharmova to proceed with the regulatory process for the product in the US. Commercial launch will depend on the expiry of the reference product's patent and the receipt of final approval from the USFDA. 

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