Dailymirror.news,Mumbai, April 2, 2025: Alembic Pharmaceuticals Limited (Alembic) has received Final Approval from the United States Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial).

This approval designates Alembic’s product as therapeutically equivalent to Protonix I.V. for Injection, 40 mg/vial, originally developed by Wyeth Pharmaceuticals LLC.

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

(Refer to the product label for complete indications and usage details.)

  • The estimated market size for Pantoprazole Sodium for Injection (40 mg/vial) is approximately US$ 48 million for the 12 months ending December 2024, as per IQVIA data.
  • With this latest approval, Alembic now holds a total of 221 ANDA approvals from the USFDA, including 195 final approvals and 26 tentative approvals.

This milestone reinforces Alembic Pharmaceuticals’ commitment to expanding its portfolio of high-quality, USFDA-approved generic medicines.