Itraconazole Oral Solution 10 mg/mL 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.
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.
Itraconazole Oral Solution — third party manufacturing & bulk supply
Itraconazole Oral Solution 10 mg/mL is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required shelf life
Manufacturers of Itraconazole Oral Solution listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Itraconazole Oral Solution →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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