Granules India bags USFDA nod for Esomeprazole Magnesium Delayed Release Capsules for GERD symptoms
Hyderabad: Granules India Limited has 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.
Granules India Limited, incorporated in 1991 is a vertically integrated Indian pharmaceutical company headquartered at Hyderabad. The Company is among the few pharmaceutical companies in the world to be present in the manufacturing of entire value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs). Its products are being distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 80+ countries with offices across India, U.S. and U.K. The Company has 7 manufacturing facilities out of which 6 are located in India and 1 in USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.
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