Granules India get US FDA’s approval for another ANDA capsule, shares dip

Granules India Limited announced that the USFDA approved its Abbreviated New Drug Application (ANDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg. These capsules serve various purposes, including the short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD) and risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcers in adults.

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The approval contributes to the company’s growing ANDA portfolio, which now totals 62 approvals from the US FDA, including 60 final and 2 tentative approvals. With the current U.S. market for Esomeprazole Magnesium Delayed-Release Capsules estimated at approximately $168 Million, according to MAT Jul 2023, IQVIA/IMS Health, the approval marks a step forward for Granules India Limited.

However, the shares fell 0.83 per cent to ₹352.60 at 1 pm on the BSE.