Lansoprazole Delayed release Capsules

Form: Capsules

Strength: 15 mg and 30 mg

Reference Brands: Prevacid(US & EU)

Category: Gastrointestinal Drugs

Lansoprazole capsules, marketed as Prevacid, 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 a comprehensive dossier including clinical efficacy, safety profiles, manufacturing quality, and pharmacovigilance plans. The FDA reviews detailed clinical trial and manufacturing data for timely approval, while the EMA ensures compliance with regional safety and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Adherence to regional regulations supports swift approval, safe medication use, and global availability, helping millions worldwide effectively manage acid-related disorders.