Levamisole Tablets

Form: Tablets

Strength: 50 mg & 150 mg

Reference Brands: Generic formulations

Category: Anthelmintic

Levamisole tablets are approved primarily in Europe for parasitic infections and immune modulation, with limited regulatory approval in the US. Regulatory dossiers must include clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews quality and safety data, while the EU’s EMA oversees regional safety and quality compliance. For guidance on dossier preparation, regulatory pathways, and market entry, visit PharmaTradz. Proper adherence to regional requirements supports timely approval, safe use, and global availability, ensuring effective treatment of parasitic infections and immune-related conditions worldwide, with a focus on safety and efficacy.