Itraconazole Iv Solution Suppliers & Bulk Manufacturers
Available Forms: Intravenous (IV) solution
Available Strengths: 200 mg/vial
Reference Brands: Sporanox(US & EU)
Category: Anti-fungal
Itraconazole IV inhibits fungal cytochrome P450 14α-demethylase, blocking ergosterol synthesis and disrupting fungal cell membranes. It provides broad-spectrum activity, rapid systemic treatment, and excellent tissue penetration. Benefits include effective management of severe fungal infections, reliable intravenous delivery, and a favorable safety profile for hospitalized patients. Itraconazole IV solution is available in Intravenous (IV) solution and strengths such as 200 mg/vial. 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, Itraconazole IV 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) |
Itraconazole IV 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:
Itraconazole IV solution is approved in the EU and US for severe fungal infections. In the EU, Janssen’s Sporanox IV is regulated by EMA, supported by dossiers demonstrating safety, efficacy, and quality. In the US, FDA approval is based on comprehensive clinical data, biosimilarity assessments, and ongoing pharmacovigilance. Both regions require detailed dossiers for initial approval and continuous safety monitoring. For expert assistance with pharmaceutical dossiers, regulatory submissions, and compliance, visit PharmaTradz, your trusted partner in regulatory solutions, facilitating efficient market access and ensuring adherence to regulatory standards for itraconazole IV formulations.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Itraconazole is used to treat a wide range of fungal infections, including aspergillosis, histoplasmosis, blastomycosis, and certain systemic or deep-tissue fungal diseases. It works by inhibiting fungal cell membrane synthesis, helping stop fungal growth and spread.
Itraconazole contains the active triazole antifungal ingredient itraconazole, along with formulation excipients suitable for parenteral administration.
Common trade names include Sporanox and Onmel (region-specific).
Branded versions such as Sporanox are produced by Janssen Pharmaceuticals. Generic itraconazole is manufactured by multiple GMP-approved pharmaceutical companies globally.
The generic name is itraconazole.
Brand names include Sporanox and Onmel.
Itraconazole is manufactured in various GMP-certified facilities worldwide, depending on the brand and market authorization requirements.
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