Granule India Pvt Ltd Medicine Approved by US FDA for Ulcer Treatment

The US Food and Drug Administration (FDA) have approved Granules India Limited's Abbreviated New Drug Application (ANDA) for esomeprazole magnesium delayed-release capsules USP, 20 mg and 40 mg. It is bioequivalent and medically equivalent to AstraZeneca Pharmaceuticals LP's Nexium delayed-release capsules (20 mg and 40 mg). Esomeprazole magnesium capsules are approved for the short-term treatment of heartburn and other GERD symptoms, the risk reduction of NSAID-associated gastric ulcer in adults at risk of developing gastric ulcers , the eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin, and the long-term treatment of pathological hypersecretory conditions, including Zollinger-Elli, as per pharmabiz.

Granules now have 62 ANDA approvals from the US FDA (60 final and two provisional). According to MAT Jul 2023, IQVIA/IMS Health, the current annual US market for esomeprazole magnesium delayed-release capsules is around $168 million. Granules India Limited, founded in 1991, is a vertically integrated, fast-growing Indian pharmaceutical firm with best-in-class facilities and a commitment to operational excellence, quality, and customer service. The company is one of the few in the world that manufactures the whole value chain, from active pharmaceutical ingredients (APIs) to pharmaceutical formulation intermediates (PFIs) and final doses (FDs). Within the pharmaceutical value chain, Granules pioneered the concept of commercializing PFIs for high-volume pharmaceuticals. They also provide a variety of completed dosage forms in bulk, blister packs, and bottles, including tablets, caplets, and press-fit capsules.