
Thiabendazole Tablets
Form: Tablets
Strength: 500 mg
Reference Brands: Mintezol(US), Tebanic(EU)
Category: Anthelmintic
Thiabendazole tablets, marketed as Mintezol and Tebanic, are approved in the US by the FDA and in the EU via EMA for treating parasitic infections. Regulatory approval requires detailed dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial and quality data, while the EMA ensures compliance with regional safety and manufacturing regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper compliance supports timely approval, safe use, and global availability, effectively managing intestinal and skin parasitic infections worldwide, supporting health efforts against parasitic diseases.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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