Alembic Pharmaceuticals Limited — Updates, 01-04-2025: Press Release

Alembic Pharmaceuticals 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). This product is therapeutically equivalent to Wyeth Pharmaceuticals' Protonix I.V. and is indicated for treating gastroesophageal reflux disease (GERD) and pathological hypersecretion conditions such as Zollinger-Ellison syndrome in adults. The estimated market size for this drug is approximately US$ 48 million for the year ending December 2024. With this approval, Alembic's cumulative total reaches 221 ANDA approvals, comprising 195 final approvals and 26 tentative approvals. This development strengthens Alembic's position in the injectable pharmaceuticals space, potentially enhancing revenue and market share. Investors should consider the positive outlook due to expanded product offerings in a growing market segment.