Gadodiamide Injectable Solution Suppliers & Bulk Manufacturers
Available Forms: Injectable Solution
Available Strengths: 0.5 mol/L
Reference Brands: Omniscan(U & EU)
Category:
Contrast Agent
Gadodiamide is a gadolinium-based contrast agent that enhances MRI scans by increasing tissue radiopacity. It improves visualization of blood vessels, organs, and abnormalities, supporting accurate diagnosis. Benefits include high image quality, rapid excretion, safety, and detailed imaging support in neurological, cardiovascular, and musculoskeletal diagnostics worldwide.
Gadodiamide 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, Gadodiamide 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) |
Gadodiamide 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:
Gadodiamide, marketed as Omniscan, is approved in the US by the FDA and in the EU via EMA for MRI contrast enhancement of neurological, cardiovascular, and musculoskeletal imaging. Regulatory approval requires a comprehensive dossier 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 standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional regulations supports swift approval, safe use, and global availability, facilitating high-quality diagnostic imaging worldwide.
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