Granules India gets ANDA approval for Pantoprazole Sodium DR tablets

Granules India announced today that the US Food & Drug Administration (US FDA) has approved 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.

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 has a total of 64 ANDA approvals from the US FDA (62 final approvals and two tentative approvals). The current annual US market for Pantoprazole Tablets is approximately $233 million, according to IQVIA/IMS Health, MAT Oct 2023.