Iohexol Injectable Solution Generics - Manufacturers & Suppliers
Omnipaque(US & EU)
| Product/Composition:- | Iohexol Injectable Solution |
|---|---|
| Strength:- | 240 mg/mL, 300 mg/mL, 350 mg/mL, 140 mg/mL |
| Form:- | Injectable Solution |
| Reference Brands:- | Omnipaque(US & EU) |
| MOQ | As per the manufacturer batch size |
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Iohexol injectable solution is a contrast agent that enhances X-ray and CT imaging by increasing vascular and tissue radiopacity. It provides clear visualization of blood vessels, organs, and tissues, aiding in accurate diagnosis. Benefits include improved imaging quality, safety, rapid excretion, and support for effective disease detection and assessment.
Iohexol injectable solution, marketed as Omnipaque, is approved in the US by the FDA and in the EU via EMA for use as a contrast agent in diagnostic imaging. Regulatory approval requires comprehensive dossiers including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. The FDA reviews detailed clinical trial and quality data for timely approval, while the EMA ensures compliance with regional safety, efficacy, and manufacturing regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence supports swift approval, safe administration, and broad global availability, enabling precise imaging for effective diagnosis and treatment planning worldwide.