Orlistat Capsule

Form: Capsules

Strength: 120 mg; Alli(60 mg)

Reference Brands: Xenical(US & EU)

Category: Weight Loss drugs

Orlistat capsules, marketed as Xenical (prescription) and Alli (OTC), are approved in the US by the FDA and in the EU via EMA for weight management and obesity. Regulatory approval requires dossiers including safety assessments, clinical efficacy, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial and quality data for effective approval, while the EMA ensures compliance with regional safety and manufacturing regulations. For dossier preparation, regulatory pathways, and market access guidance, visit PharmaTradz. Proper regional adherence supports timely approval, safe use, and global availability, helping consumers worldwide achieve weight loss through effective dietary fat-blocking therapy supported by regional regulations.