Alembic Pharmaceuticals Secures USFDA Approval for Pantoprazole Sodium Injection
Alembic Pharmaceuticals has received final USFDA approval for Pantoprazole Sodium for Injection, 40 mg/vial. The drug, equivalent to Wyeth's Protonix I.V., is used to treat GERD and other gastric conditions. The estimated market size for this product is $48 million. This approval brings Alembic's total ANDA approvals to 221, including 195 final and 26 tentative approvals.

*this image is generated using AI for illustrative purposes only.
Alembic Pharmaceuticals has achieved a significant milestone in its pharmaceutical portfolio expansion. The company announced on April 1, 2025, that it has received final approval from the United States Food and Drug Administration (USFDA) for its Pantoprazole Sodium for Injection, 40 mg/vial in single-dose vials.
Product Details and Market Potential
The approved Abbreviated New Drug Application (ANDA) for Pantoprazole Sodium for Injection is therapeutically equivalent to the reference listed drug product, Protonix I.V. for Injection, 40 mg/vial, manufactured by Wyeth Pharmaceuticals LLC. This injection is primarily indicated for:
- Treatment of gastroesophageal reflux disease (GERD) in adults for up to 10 days
- Treatment of adults with a history of erosive esophagitis (EE)
- Treatment of pathological hypersecretion conditions, including Zollinger-Ellison (ZE) Syndrome in adults
According to IQVIA data, the estimated market size for Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial) is approximately $48.00 million for the twelve months ending December 2024.
Alembic's Growing ANDA Portfolio
With this latest approval, Alembic Pharmaceuticals has further strengthened its position in the U.S. generic pharmaceutical market. The company now boasts a cumulative total of 221 ANDA approvals from the USFDA:
Approval Type | Count |
---|---|
Final | 195 |
Tentative | 26 |
Total | 221 |
This extensive portfolio demonstrates Alembic's commitment to expanding its presence in the highly competitive U.S. pharmaceutical market.
Company Overview
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been a prominent player in the healthcare sector since 1907. Headquartered in India, the company is publicly listed and specializes in manufacturing and marketing generic pharmaceutical products globally.
Key Features:
- State-of-the-art research and manufacturing facilities
- Approvals from regulatory authorities of many developed countries, including the USFDA
- Leader in branded generics in India
- Field force of over 5,200 representatives
- Well-recognized brands among doctors and patients
This latest USFDA approval for Pantoprazole Sodium for Injection marks another important step in Alembic's growth strategy, further cementing its position as a key player in the global pharmaceutical industry.
Historical Stock Returns for Alembic Pharmaceuticals
1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
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-0.24% | +0.41% | +3.39% | -28.30% | -8.72% | +37.69% |