Alembic Pharmaceuticals Limited announces USFDA Final Approval for Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial)

1st April, 2025, Bengaluru: Alembic Pharmaceuticals Limited (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDAPantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial). The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Protonix I.V. for Injection, 40 mg/vial, of Wyeth Pharmaceuticals LLC. Pantoprazole sodium for injection is indicated for treatment of gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults.

It is also indicated for the treatment of pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome in adults. Refer label for a detailed indication.

Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial) have an estimated market size of US$ 48 million for twelve months ending December 2024 according to IQVIA.

Alembic has a cumulative total of 221 ANDA approvals (195 final approvals and 26 tentative approvals) from USFDA.