Dimethyl Fumarate Capsule Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 120 mg and 240 mg

Reference Brands: Tecfidera(US & EU)

Category: Multiple sclerosis

Dimethyl Fumarate Capsule is available in Capsules and strengths such as 120 mg and 240 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, Dimethyl Fumarate Capsule is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Dimethyl Fumarate Capsule 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.

Product Description: Dimethyl fumarate capsules, marketed as Tecfidera, are approved in the US by the FDA and in the EU via EMA for multiple sclerosis treatment. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. In the US, FDA review involves evaluation of clinical trial results and manufacturing standards, while the EMA ensures compliance with regional safety and quality requirements. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regional regulatory compliance is critical for the timely approval, safe use, and global availability of dimethyl fumarate capsules, supporting effective MS management worldwide.