Itraconazole Oral Solution Suppliers & Bulk Manufacturers
Available Forms: Oral Solution
Available Strengths: 10 mg/mL
Reference Brands: Sporanox(US & EU)
Category: Anti-fungal
traconazole oral solution inhibits fungal cytochrome P450 14α-demethylase, disrupting ergosterol synthesis and fungal cell membrane formation. It effectively treats systemic and dermatophyte fungal infections. Benefits include excellent tissue penetration, broad-spectrum activity, oral administration, and a good safety profile—making it an essential choice for managing various fungal diseases. Itraconazole Oral Solution is available in Oral Solution and strengths such as 10 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, Itraconazole Oral 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 Oral 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 oral solution is approved in the EU and US for treating fungal infections. In the EU, Janssen’s Sporanox oral solution is regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA-approved Sporanox oral solution and generics are backed by comprehensive clinical data, biosimilarity assessments, and pharmacovigilance. Both regions require detailed regulatory dossiers for approval and ongoing safety monitoring. For expert assistance with pharmaceutical dossiers, regulatory submissions, and compliance, visit PharmaTradz, your trusted partner in regulatory solutions, ensuring efficient market access and adherence to regulatory standards for itraconazole oral solutions.
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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