Alembic Pharma Gets USFDA Nod for Pantoprazole Sodium Injection, Market Size Pegged at $48 Million

Alembic Pharmaceuticals Limited has secured final approval from the United States Food and Drug Administration (USFDA) for its Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial). The approval confirms that Alembic’s formulation is therapeutically equivalent to the reference listed drug, Protonix I.V., manufactured by Wyeth Pharmaceuticals LLC.

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

About the Drug and Therapeutic Use

Pantoprazole belongs to a class of medications known as proton pump inhibitors (PPIs). It works by reducing the amount of acid produced in the stomach, thereby providing relief from acid reflux and promoting healing of the esophagus in cases of erosive esophagitis.

This injectable form is especially used in hospital settings where oral administration may not be feasible, making it a valuable treatment option for acute care.

Market Potential

According to IQVIA data, the estimated market size for Pantoprazole Sodium for Injection in the US stood at $48 million for the twelve months ending December 2024. The approval marks another addition to Alembic’s growing US portfolio, bringing its cumulative ANDA (Abbreviated New Drug Application) tally to 221, which includes 195 final approvals and 26 tentative approvals.

The company continues to strengthen its US presence with a pipeline of injectable and oral formulations across various therapeutic areas.

Alembic Pharmaceuticals Share Price Performance

Despite the regulatory achievement, shares of Alembic Pharmaceuticals closed 3.54% lower on April 1, 2025, at ₹896.85 apiece. The stock has declined nearly 24% over the past six months and is down over 13% in the calendar year 2025 so far.

Conclusion

Alembic Pharmaceuticals’ latest USFDA approval reinforces its strategy to expand its generic injectable offerings in the US market. As it continues to receive key regulatory clearances, the company remains focused on enhancing its international portfolio amid a competitive pharmaceutical landscape.

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