Alembic Pharma Secures USFDA Approval for Pantoprazole Injection

1 Apr 2025 , 01:58 PM

Alembic Pharmaceuticals Limited has received the final approval from USFDA for its Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial). This product is therapeutically equivalent to the reference listed drug Protonix I.V. for Injection (40 mg/vial) manufactured by Wyeth Pharmaceuticals LLC.

Pantoprazole Sodium Injection is indicated for the short-term treatment (up to 10 days) of gastroesophageal reflux disease (GERD) and erosive esophagitis (EE) in adults. The injection is also prescribed for pathological hypersecretion conditions, including Zollinger-Ellison (ZE) Syndrome.

Four months ended June 30, 2025, as reported by IQVIA, the approximate US market size for Pantoprazole Sodium for Injection was $48 million for the twelve months ended December 2024.

This recent approval has taken Alembic Pharmaceuticals’ cumulative ANDA approvals from the USFDA to 221, comprising 195 final approvals and 26 tentative approvals. This approval bolsters Alembic’s portfolio in the United States market and reinforces its presence in injectable segment