Gadoxetate Injectable Solution Suppliers & Bulk Manufacturers
Available Forms: Injectable Solution
Available Strengths: 0.25 mmol/mL
Reference Brands: Eovist(US)
Category:
Contrast Agent
Gadoxetate is a gadolinium-based contrast agent that accumulates in liver cells, enhancing MRI images for detailed hepatobiliary assessment. It improves detection of liver lesions, supports early diagnosis, and aids in differentiating benign from malignant tumors. Benefits include high-resolution imaging, early detection, and accurate disease staging.
Gadoxetate Injectable Solution is available in Injectable Solution
and strengths such as 0.25 mmol/mL.
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, Gadoxetate 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) |
Gadoxetate 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:
Gadoxetate, marketed as Primovist in the EU and Eovist in the US, is approved for liver MRI by the EMA and FDA for hepatobiliary imaging. Regulatory approval requires a detailed dossier, including clinical efficacy, safety profiles, 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 supports swift approval, safe administration, and worldwide availability, supporting early diagnosis and optimal management of liver diseases across healthcare regions globally.
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