Itraconazole Capsules 100 mg Suppliers & Bulk Manufacturers
Available Forms: Oral Capsules
Available Strengths: 100 mg
Reference Brands: Sporanox(US & EU)
Category: Anti-fungal
Itraconazole inhibits fungal cytochrome P450 enzyme 14α-demethylase, disrupting ergosterol synthesis and fungal cell membrane formation. It effectively treats a broad range of fungal infections, including systemic and dermatophyte infections. Benefits include oral administration, good tissue penetration, broad-spectrum activity, and a favorable safety profile for managing fungal diseases.
Product Description:
Itraconazole capsules are approved in the EU and US for treating fungal infections. In the EU, Janssen’s Sporanox and generics are regulated by EMA, backed by comprehensive dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, the FDA approved Sporanox and generic versions based on detailed clinical data, biosimilarity assessments, and ongoing pharmacovigilance. Both regions require robust regulatory dossiers for initial approval and continued safety monitoring. For expert assistance with pharmaceutical dossiers, regulatory submissions, and compliance, visit PharmaTradz, your trusted partner in regulatory solutions, helping facilitate timely market access for itraconazole capsules.
Itraconazole Capsules — third party manufacturing & bulk supply
Itraconazole Capsules 100 mg 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 Capsules 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 Capsules →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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