Pyrantel Pamoate Chewable Tablets

Form: Tablets

Strength: 11 mg

Reference Brands: Pin-X(US),Combantrin(EU)

Category: Anthelmintic

Pyrantel pamoate tablets, marketed as Pin-X in the US and as generic or local brands in the EU, are approved for treating intestinal parasitic infections. Regulatory approval requires the submission of dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews clinical trial and quality data for timely approval, whereas the EU’s EMA ensures compliance with regional safety standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper compliance supports swift approval, safe use, and global availability, enabling effective antiparasitic therapy worldwide for children and adults.