Granules India Ltd received ANDA Approval for Esomeprazole Magnesium Delayed-Release Capsules

Granules India Limited announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg. It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Nexium Delayed-Release Capsules, 20 mg and 40 mg, of AstraZeneca Pharmaceuticals LP.

Esomeprazole Magnesium capsules are indicated for short-term treatment of heartburn and other symptoms associated GERD, risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers, helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin and long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Granules now have a total of 62 ANDA approvals from the US FDA (60 final and 2 tentative approvals).

The current annual U.S. market for Esomeprazole Magnesium Delayed-Release Capsules is approximately $168 Million, according to MAT Jul 2023, IQVIA/IMS Health.

Shares of Granules India Limited was last trading in BSE at Rs. 353.20 as compared to the previous close of Rs. 355.70. The total number of shares traded during the day was 23829 in over 717 trades.

The stock hit an intraday high of Rs. 355.65 and intraday low of 350.05. The net turnover during the day was Rs. 8404332.00.

Source : Equity Bulls

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GranulesIndia INE101D01020 ANDAApproval USFDA