Gadoteridol Injectable Solution bulk supplier for pharma manufacturers

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 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.

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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.

Frequently Asked Questions

Yes, Gadoteridol Injectable Solution is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Gadoteridol Injectable Solution is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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