Jubilant Pharmova arm gets tentative nod from US FDA for Pantoprazole Sodium
This story was originally published at 13:32 IST on 27 June 2026
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--Jubilant Pharmova arm gets US FDA tentative nod for Pantoprazole Sodium
MUMBAI – Jubilant Pharmova Ltd. said its wholly-owned step-down subsidiary Jubilant Generics Ltd. has received a tentative approval from the US Food and Drug Administration for pantoprazole sodium delayed release oral suspension, 40 milligrams per packet. Pantoprazole sodium is a proton pump inhibitor prescribed to decrease the acid produced in the stomach.
The US FDA has concluded pre-approval inspection at the solid dosage manufacturing facility in Roorkee, Uttarakhand, Jubilant Pharmova said in an exchange filing Friday. The tentative approval is subject to the expiry of the patent covering the drug. The patent is expected to expire in December. The final approval is anticipated upon such patent expiry, the company said in the filing.
For the March quarter, on a consolidated basis, Jubilant Pharmova had reported a net profit of INR 1.19 billion on revenues of INR 22.90 billion. Thursday, its shares ended at INR 964.40 on the National Stock Exchange, down nearly 1% from Wednesday. The stock market was shut Friday for Muharram. End
Reported by Ashvita Chalke
Edited by Rajeev Pai
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