Tetrabenazine Tablets 25 mg, 50 mg, 75 mg Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 25 mg, 50 mg, 75 mg
Reference Brands: Xenazine(US)
Category: Orphan Drugs
Tetrabenazine is a vesicular monoamine transporter 2 (VMAT2) inhibitor that depletes dopamine, serotonin, and norepinephrine in nerve terminals. It effectively reduces hyperkinetic movements like chorea in Huntington’s disease, supporting symptom control, improving motor function, and enhancing quality of life in movement disorder patients worldwide.
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.
Tetrabenazine Tablets — third party manufacturing & bulk supply
Tetrabenazine Tablets 25 mg, 50 mg, 75 mg is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required shelf life
Manufacturers of Tetrabenazine Tablets listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Tetrabenazine Tablets →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Tetrabenazine is used for the treatment of chorea associated with Huntington’s disease. It helps reduce involuntary, irregular, and jerky movements by decreasing excessive dopamine activity in the brain. It may also be used off-label for other hyperkinetic movement disorders under specialist supervision.
Tetrabenazine is a synthetic small-molecule compound developed to reversibly inhibit vesicular monoamine transporter type 2 (VMAT2). This action reduces the storage and release of monoamines such as dopamine, serotonin, and norepinephrine in nerve terminals.
Tetrabenazine is marketed under trade names such as Xenazine and Nitoman.
Xenazine was originally developed by Prestwick Pharmaceuticals and later marketed by Lundbeck. Generic versions of tetrabenazine are manufactured by multiple pharmaceutical companies worldwide.
The complete generic name is tetrabenazine.
The brand names of tetrabenazine include Xenazine and Nitoman, along with various generic brand names depending on the country and manufacturer.
Tetrabenazine is manufactured in multiple countries, including the USA, EU nations, India, and other regulated pharmaceutical markets, depending on the brand owner and generic manufacturer.
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