Granules India Limited announced the approval of its abbreviated new drug application ((ANDA) by the US Food and Drug Administration (US FDA) for pantoprazole sodium delayed-release tablets USP in both 20 mg and 40 mg strengths.
These tablets are identified as bioequivalent and therapeutically equivalent to the Protonix delayed-release tablets of Wyeth Pharmaceuticals LLC, to treat erosive oesophagitis associated with gastro-oesophageal reflux disease (GERD). The company reported that the tablets are indicated for maintaining healing in such conditions and addressing pathological hypersecretory conditions, including Zollinger-Ellison (ZE) syndrome.
Granules’ total ANDA approvals from the US FDA now stands at 64 (62 final and two tentative approvals). The market for pantoprazole tablets in the US is estimated to be about $233 million annually, according to IQVIA/IMS Health.
However, shares were down by 0.66 per cent to Rs 386.30 at 12.15 pm on the BSE.