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 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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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.
Frequently Asked Questions
Related Products
Nystatin Oral Suspensions/Tablets
Strength:
Tab: 500,000 units, 1,000,000 units; Sus: 100,000 units/mL, 500,000 units/5 mL
Form: Tablets/Suspensions
Reference Brands: Mycostatin, Nilstat, Nystop(US)
View Details
Nystatin Topical Creams And Ointments
Strength:
100,000 units/g, 100,000–300,000 units/g
Form: Topical Creams and Ointments
Reference Brands: Mycostatin, Nilstat, Nystop(US)
View Details
Micafungin Intravenous (Iv) Powder
Strength:
50 mg, 100 mg/vial
Form: Intravenous (IV) Powder
Reference Brands: Mycamine(US & EU)
View Details
Anidulafungin Injection
Strength:
50 mg/vial
Form: Intravenous (IV) Powder
Reference Brands: Eraxis(US)
View DetailsQuick Response Guaranteed | Verified Suppliers
