Alembic Pharma bags USFDA final approval for Pantoprazole Sodium for Injection for GERD

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-04-02 09:18 GMT   |   Update On 2025-04-02 09:18 GMT

Vadodara: Alembic Pharmaceuticals Limited has announced that it 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).

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.
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.
Medical Dilaogues team had earlier reported that the Company had received Final Approval from the USFDA for its ANDA for Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg. 

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

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.

Read also: Alembic Pharma appoints Prag Goel as Vice President - Sales and Marketing (Megacare, Enteron and Osteofit business divisions)

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