Esomeprazole Magnesium Capsules

Form: Capsules

Strength: 20 mg, 40 mg

Reference Brands: Nexium(US & EU)

Category: Gastrointestinal Drugs

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.