Alembic Pharmaceuticals has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial). Alembic has a cumulative total of 221 ANDA approvals (195 final approvals and 26 tentative approvals) from USFDA.
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.
Alembic Pharmaceuticals is principally engaged in the manufacturing and selling of pharmaceuticals products i.e. Formulations and Active Pharmaceutical Ingredients.
