Alembic Pharmaceuticals (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Pantoprazole Sodium.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Protonix I.V. for Injection, of Wyeth Pharmaceuticals LLC. Pantoprazole sodium for 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. It is also indicated for the treatment of pathological hypersecretion conditions, including Zollinger-Ellison (ZE) syndrome in adults. Refer to the label for a detailed indication.
With this approval, Alembic has a cumulative total of 221 ANDA approvals from the USFDA, including 195 final approvals and 26 tentative approvals.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.
The companys consolidated net profit tumbled 23.29% to Rs 138.42 crore in Q3 FY25, compared with Rs 180.45 crore posted in Q3 FY24. Revenue from operations was at Rs 1,692.74 crore in the third quarter of FY25, up 3.81% year on year (YoY).
According to IQVIA, the estimated market size for pantoprazole sodium for injection was US$ 48 million for the twelve months ending December 2024.
