Itraconazole Capsules 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. Itraconazole Capsules is available in Oral Capsules and strengths such as 100 mg. 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 Capsules 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 Capsules 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 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.
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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