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.
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