Granules India Limited announced that the US Food & Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for pantoprazole sodium delayed-release tablets USP, 20 mg and 40 mg. It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Protonix delayed-release tablets, 20 mg and 40 mg, of Wyeth Pharmaceuticals LLC.
Pantoprazole sodium delayed-release tablets are indicated for short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD), maintenance of healing of erosive esophagitis and pathological hypersecretory conditions including zollinger-ellison (ZE) syndrome.
Granules now has a total of 64 ANDA approvals from the US FDA (62 final approvals and 2 tentative approvals).
Granules India Limited, incorporated in 1991 is a vertically integrated fast growing Indian pharmaceutical company headquartered at Hyderabad with best in class facilities and commitment to operational excellence, quality, and customer service.
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