Alembic Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (USFDA) for its generic version of Pantoprazole Sodium for Injection, 40 mg/vial in single-dose form.

The drug is a therapeutic equivalent to Protonix I.V., originally developed by Wyeth Pharmaceuticals, and is used to manage gastroesophageal reflux disease (GERD), erosive esophagitis, and certain rare hypersecretion conditions like Zollinger-Ellison Syndrome in adults.

This approval marks yet another milestone in Alembic’s growing U.S. portfolio, with the company now holding a total of 221 Abbreviated New Drug Application (ANDA) approvals—195 of them final. According to IQVIA data, the estimated U.S. market size for this particular formulation stands at approximately USD 48 million for the twelve months ending December 2024.

Alembic, which has been operating since 1907, continues to build on its legacy as a leading player in both branded generics in India and regulated markets globally. Its vertically integrated research, development, and manufacturing operations have received approval from top regulatory bodies, including the USFDA, further solidifying its position on the international stage.