Granules India Ltd received ANDA Approval for Pantoprazole Sodium Delayed-Release Tablets

Granules India Limited announced that the US Food & Drug Administration (US 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).

The current annual U.S. market for Pantoprazole Tablets is approximately $233 million, according to IQVIA/IMS Health, MAT Oct 2023.

Shares of Granules India Limited was last trading in BSE at Rs. 388.85 as compared to the previous close of Rs. 386.45. The total number of shares traded during the day was 36379 in over 982 trades.

The stock hit an intraday high of Rs. 395.30 and intraday low of 387.40. The net turnover during the day was Rs. 14235752.00.

Source : Equity Bulls

Keywords

GranulesIndia INE101D01020 ANDA Approval USFDA PantoprazoleSodium DelayedReleaseTablets