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 is a gadolinium-based contrast agent that shortens relaxation times in MRI scans, enhancing tissue and blood vessel visibility. It provides clear, high-resolution images of the brain, spine, and joints. Benefits include improved diagnostic accuracy, rapid imaging, safety, and support for effective detection of abnormalities.
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.
|
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) |
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.
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