Jubilant Pharmova on Thursday said its subsidiary, Jubilant Generics, has received tentative approval from the United States Food and Drug Administration (USFDA) for Pantoprazole Sodium Delayed Release Oral Suspension, 40 mg per packet.
The company disclosed the development in a regulatory filing. Jubilant Generics is a subsidiary of Jubilant Pharma, which is the wholly-owned subsidiary of Jubilant Pharmova.
Approval follows Roorkee facility inspection
The approval comes after the successful completion of a pre-approval inspection (PAI) by the USFDA at the company’s solid dosage manufacturing facility in Roorkee. Jubilant Pharmova had informed exchanges about the inspection outcome on August 2, 2025.
Pantoprazole is commonly used to treat conditions related to excess stomach acid, including gastroesophageal reflux disease (GERD).
Final approval expected after patent expiry
The company said the tentative approval remains subject to the expiry of the patent covering the currently listed Reference Listed Drug (RLD).
According to the filing, the patent is expected to expire in December 2026. Jubilant Pharmova expects to receive final approval from the USFDA after the patent expiry.
About Jubilant Pharmova
Jubilant Pharmova is a global integrated pharmaceutical company and part of the Jubilant Bhartia Group. Headquartered in Noida, the company operates across six key business segments—Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, Generics, Contract Research Development and Manufacturing Organisation (CRDMO), and Proprietary Novel Drugs. It has a strong global presence with manufacturing facilities and research centres in India and North America, serving regulated markets including the US and Europe.
Jubilant Pharmova is particularly known for its radiopharmaceuticals business, supported by an extensive network of radiopharmacies in the US, and employs over 5,500 people worldwide. The company focuses on advancing healthcare through innovation, precision manufacturing, and research-driven pharmaceutical solutions.
Jubilant Pharmova share price
The share price of Jubilant Pharmova has declined 8.88% so far this year.