Alembic Pharma secures USFDA approval for acid reflux treatment injection

 

According to IQVIA data, the estimated market size for Pantoprazole Sodium for Injection in the US was $48 million for the twelve months ending December 2024.




The approval from the US Food and Drug Administration (USFDA) for its Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial). This approval makes Alembic’s product therapeutically equivalent to the reference listed drug Protonix I.V. for Injection, 40 mg/vial, manufactured by Wyeth Pharmaceuticals LLC.

Pantoprazole sodium injection is used for the treatment of gastroesophageal reflux disease (GERD) and erosive esophagitis (EE) for up to 10 days in adults. It is also prescribed for pathological hypersecretion conditions, including Zollinger-Ellison (ZE) Syndrome. According to IQVIA data, the estimated market size for Pantoprazole Sodium for Injection in the US was $48 million for the twelve months ending December 2024.

With this approval, Alembic Pharmaceuticals now holds a cumulative total of 221 ANDA approvals from the USFDA, comprising 195 final approvals and 26 tentative approvals. The shares of the pharmaceutical company are trading 2.5% in the red at 1 pm on Tuesday (April 1). The stock has witnessed a fall of close to 24% in the past six months and over 13% in 2025 so far. 

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