
Baclofen Tablets: Suppliers & Bulk Manufacturers
Available Forms: Tablet
Available Strengths: 10 mg and 20 mg
Reference Brands: Lioresal, Gablofen(US & EU)
Category: Multiple sclerosis
Baclofen Tablets: is available in Tablet and strengths such as 10 mg and 20 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, Baclofen 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) |
Baclofen 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:
Baclofen tablets, marketed as Lioresal, are approved in the US by the FDA and in the EU via EMA for treating spasticity in multiple sclerosis, spinal cord injury, and other neurological conditions. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trial and manufacturing information, while the EMA ensures compliance with regional safety and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring thorough regulatory compliance is crucial for timely approval, safe use, and global availability of Baclofen tablets, supporting optimal patient management worldwide.
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