Alembic Pharmaceuticals Ltd announces USFDA Final Approval for Pantoprazole Sodium for Injection, 40 mg/vial - Single-Dose Vial

Alembic Pharmaceuticals Limited (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial). The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Protonix I.V. for Injection, 40 mg/vial, of Wyeth Pharmaceuticals LLC. Pantoprazole sodium for injection is indicated for treatment of gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. It is also indicated for the treatment of pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome in adults. Refer label for a detailed indication.

Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial) have an estimated market size of US$ 48 million for twelve months ending December 2024 according to IQVIA.

Alembic has a cumulative total of 221 ANDA approvals (195 final approvals and 26 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 929.25 as compared to the previous close of Rs. 930.90. The total number of shares traded during the day was 4684 in over 560 trades.

The stock hit an intraday high of Rs. 937.85 and intraday low of 895.85. The net turnover during the day was Rs. 4257894.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA FinalApproval ANDA PantoprazoleSodium Injection SingleDoseVial