Gadoteridol Injectable Solution Suppliers & Bulk Manufacturers
Available Forms: Injectable Solution
Available Strengths: 0.5 mol/L
Reference Brands: ProHance(US & EU)
Category:
Contrast Agent
Gadoteridol is a gadolinium-based contrast agent that enhances MRI images by increasing tissue radiopacity. It improves visualization of blood vessels, organs, and abnormalities, supporting accurate diagnosis. Benefits include high image clarity, rapid clearance, safety, and detailed imaging that aids effective neurological, cardiovascular, and musculoskeletal assessments worldwide.
Gadoteridol 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, Gadoteridol 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) |
Gadoteridol 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:
Gadoteridol injectable solution, marketed as ProHance, is approved in the US by the FDA and in the EU via EMA for MRI contrast enhancement. 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 compliance with regional safety and manufacturing regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper regional adherence supports swift approval, safe administration, and worldwide availability, enabling high-quality diagnostic imaging for neurological, cardiovascular, and musculoskeletal assessments globally.
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