
Ioversol Injectable Solution Suppliers & Bulk Manufacturers
Available Forms: Injectable Solution
Available Strengths: 320 mg/mL, 350 mg/mL, 370 mg/mL
Reference Brands: Optiray(US & EU)
Category: Contrast Agent
Ioversol Injectable Solution is available in Injectable Solution and strengths such as 320 mg/mL, 350 mg/mL, 370 mg/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, Ioversol 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) |
Ioversol 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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Product Description: Ioversol injectable solution, marketed as Optiray, is approved in the US by the FDA and in the EU via EMA for diagnostic imaging procedures like CT angiography and vascular imaging. Regulatory approval requires comprehensive dossiers including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial data and quality documentation 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 requirements supports swift approval, safe administration, and global availability, facilitating high-quality radiological diagnostics worldwide.
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