Dimethyl Fumarate Capsule

Form: Capsules

Strength: 120 mg and 240 mg

Reference Brands: Tecfidera(US & EU)

Category: Multiple sclerosis

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.