Granules India has received US Food & Drug Administration (USFDA) approval for 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 USFDA (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.
Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).
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