Alembic Pharmaceuticals Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial), the company announced on Monday.
The approved injection is therapeutically equivalent to the reference listed drug product, Protonix I.V. for Injection, 40 mg/vial, manufactured by Wyeth Pharmaceuticals LLC. This approval strengthens Alembic's growing portfolio of FDA-approved medications.
Therapeutic Applications
Pantoprazole Sodium for Injection is primarily indicated for the treatment of gastroesophageal reflux disease (GERD) in adults with a history of erosive esophagitis. The treatment duration is specified for up to 10 days. Additionally, the medication is approved for treating pathological hypersecretion conditions, including Zollinger-Ellison Syndrome in adult patients.
As a proton pump inhibitor, pantoprazole works by reducing stomach acid production, providing relief for patients suffering from severe acid reflux and related conditions.
Market Impact and Commercial Significance
According to IQVIA data cited by the company, Pantoprazole Sodium for Injection has an estimated market size of US$48 million for the twelve-month period ending December 2024. This approval allows Alembic to enter this substantial market segment with its generic alternative.
The approval marks another milestone for Alembic's U.S. market strategy. The company now holds a cumulative total of 221 ANDA approvals from the FDA, comprising 195 final approvals and 26 tentative approvals.
Company Profile
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company headquartered in India. The publicly listed company manufactures and markets generic pharmaceutical products globally.
The company's state-of-the-art research and manufacturing facilities have received approvals from regulatory authorities in numerous developed countries, including the FDA. This latest approval further validates the company's quality standards and manufacturing capabilities.
Earlier this year, Alembic also received FDA approval for Brexpiprazole Tablets in various strengths, demonstrating the company's continued success in expanding its U.S. product portfolio.
The approval comes at a time when healthcare providers are seeking cost-effective alternatives to branded medications, potentially offering savings for patients requiring treatment for GERD and related conditions.
