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 is a gadolinium-based contrast agent that enhances MRI images by shortening relaxation times, improving tissue contrast. It provides clear visualization of blood vessels, organs, and abnormalities. Benefits include high image quality, safety, rapid clearance, and support for accurate diagnosis in neurological, cardiovascular, and musculoskeletal imaging.
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.
|
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) |
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.
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