Product/Composition:- | Esomeprazole Capsules |
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Strength:- | 20 mg, 40 mg |
Form:- | Capsules |
Reference Brands:- | Nexium(US & EU) |
MOQ | As per the manufacturer batch size |
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Esomeprazole capsules are proton pump inhibitors (PPIs) that irreversibly block gastric acid secretion by inhibiting the H+/K+ ATPase enzyme in stomach cells. They effectively treat GERD, ulcers, and Zollinger-Ellison syndrome, providing relief from acid reflux, promoting mucosal healing, and preventing complications caused by excess stomach acid.
Esomeprazole capsules, marketed as Nexium, are approved in the US by the FDA and in the EU via EMA for gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews detailed clinical trial and quality information for timely approval, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regional compliance supports swift approval, safe use, and global availability of esomeprazole capsules, helping manage acid-related disorders worldwide effectively.