Tetrabenazine Tablets Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 25 mg, 50 mg, 75 mg
Reference Brands: Xenazine(US)
Category: Orphan Drugs
Tetrabenazine tablets is available in Tablets and strengths such as 25 mg, 50 mg, 75 mg. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Tetrabenazine tablets is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.
| Technical Specifications & Supply Details | |
|---|---|
| Lead Time | 7 to 60 days (depending on batch size & schedule) |
| MOQ | As per manufacturer’s batch size |
| COA | Available with every batch |
| Regulatory Dossier / DMF | Available upon request |
| Export Documentation | FSC, COA, Manufacturing License, Product Permission |
| Standards | IP, BP, USP |
| Certifications | WHO-GMP, EU-GMP, USFDA (as applicable) |
Tetrabenazine tablets can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Product Description: Tetrabenazine tablets, marketed as Xenazine, are approved in the US by the FDA and in the EU via EMA for treating hyperkinetic movement disorders such as Huntington’s disease chorea. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial and quality data to ensure safety and efficacy, while the EMA ensures regional compliance with safety and manufacturing regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper regional adherence supports timely approval, safe use, and worldwide availability, helping improve quality of life for patients with movement disorders.
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