Gadoterate Meglumine Injectable Solution Suppliers & Bulk Manufacturers

Available Forms: Injectable Solution

Available Strengths: 0.5 mol/L

Reference Brands: Dotarem(US & EU)

Category: Contrast Agent

Gadoterate Meglumine Injectable Solution is available in Injectable Solution and strengths such as 0.5 mol/L. 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, Gadoterate Meglumine Injectable Solution is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Gadoterate Meglumine Injectable Solution 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: Gadoterate meglumine, marketed as Dotarem, is approved in the US by the FDA and in the EU via EMA for MRI diagnostics of brain, spinal cord, and joints. Regulatory approval requires comprehensive dossiers including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. The FDA reviews detailed clinical trial and quality data for timely approval, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper regional adherence supports swift approval, safe administration, and global availability, assisting healthcare providers worldwide in delivering high-quality diagnostic imaging.