Alembic Pharma gets USFDA nod for pantoprazole injection
Alembic Pharmaceuticals Limited (BSE:APLLTD) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial). The approved ANDA is therapeutically equivalent to Protonix I.V.. Pantoprazole Sodium injection is indicated for the treatment of gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults and is also indicated for the treatment of pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome in adults. Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial) have an estimated market size of USD 48 million for the twelve months ending December 2024. Alembic Pharmaceuticals now has a cumulative total of 221 ANDA approvals, including 195 final and 26 tentative approvals, from the USFDA.
This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com
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