Dexlansoprazole Capsules

Form: Capsules

Strength: 30 mg and 60 mg

Reference Brands: Dexilant(US & EU)

Category: Gastrointestinal Drugs

Dexlansoprazole capsules, marketed as Dexilant, are approved in the US by the FDA and in the EU via EMA for GERD, erosive esophagitis, and Zollinger-Ellison syndrome. Regulatory approval requires detailed dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial and quality data 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. Proper regional adherence supports swift approval, safe medication use, and global availability, helping millions worldwide effectively manage acid-related disorders.