Gadoxetate Injectable Solution bulk supplier for pharma manufacturers

Gadoxetate Injectable Solution 0.25 mmol/mL Suppliers & Bulk Manufacturers

Available Forms: Injectable Solution

Available Strengths: 0.25 mmol/mL

Reference Brands: Eovist(US)

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.

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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.

Gadoxetate Injectable Solution — third party manufacturing & bulk supply

Gadoxetate Injectable Solution 0.25 mmol/mL is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Gadoxetate Injectable Solution is supplied as Injectable Solution — an injectable dosage form, so the indicative MOQ is 50,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Gadoxetate Injectable Solution listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Gadoxetate Injectable Solution is listed as Injectable Solution in 0.25 mmol/mL. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Gadoxetate Injectable Solution is referenced against Eovist(US). Reference brands are shown for identification only and remain the property of their respective trademark owners.