Alembic Pharmaceuticals Ltd has been granted final approval by the United States Food and Drug Administration (USFDA) for its Pantoprazole Sodium Injection, another step in the company's drive to build its presence in the U.S. generics market. The approval is for the injectable formulation of Pantoprazole, which is used to treat gastroesophageal reflux disease (GERD) and other acid-related disorders.
Key Highlights:
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Product Specifications: Pantoprazole Sodium Injection is a proton pump inhibitor (PPI) indicated for short-term therapy of conditions such as Zollinger-Ellison Syndrome and erosive esophagitis related to GERD. The product will come in 40 mg strength.
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Market Opportunity: Based on IQVIA market data, the U.S. market size opportunity for Pantoprazole Sodium Injection is $80 million in annual sales with high growth opportunity for Alembic Pharmaceuticals.
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Strategic Significance: This approval further enhances Alembic's injectable pipeline and is in line with its plans to increase its presence in the highly regulated U.S. pharma market.
Leadership Views:
Alembic Pharmaceuticals' spokesperson averred, "This approval reinforces our commitment to providing high-quality and cost-effective healthcare solutions worldwide."
Outlook
With this addition to its portfolio, Alembic Pharmaceuticals is ready to take a significant part of the U.S. market while it remains committed to innovation and quality.
Sources: USFDA Press Release, Economic Times, Business Standard; April 1, 2025