Granules India has received US Food & Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA) for Pantoprazole Sodium Delayed-Release Tablets USP, 20 mg and 40 mg. It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Protonix Delayed-Release Tablets, 20 mg and 40 mg, of Wyeth Pharmaceuticals LLC.
Pantoprazole Sodium Delayed-Release Tablets are indicated for short-term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD), Maintenance of Healing of Erosive Esophagitis and Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome.
Granules now has a total of 64 ANDA approvals from the USFDA (62 final approvals and 2 tentative approvals). The current annual U.S. market for Pantoprazole Tablets is around $233 million, according to IQVIA/IMS Health, MAT October 2023.
Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).
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