Gadobutrol Injectable Solution Suppliers & Bulk Manufacturers

Available Forms: Injectable Solution

Available Strengths: 1.0 mol/L

Reference Brands: Gadavist(US & EU)

Category: Contrast Agent

Gadobutrol Injectable Solution is available in Injectable Solution and strengths such as 1.0 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, Gadobutrol Injectable Solution is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Gadobutrol 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: Gadobutrol injectable solution, marketed as Gadavist, is approved in the US by the FDA and in the EU via EMA for contrast-enhanced MRI procedures. Regulatory approval requires comprehensive dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial and quality data for timely approval, while the EMA ensures regional safety and manufacturing compliance. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional regulations supports swift approval, safe administration, and global availability, enhancing diagnostic accuracy in neurological, cardiovascular, and musculoskeletal imaging worldwide.