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.
Disclaimer: By continuing to browse, you agree to the terms of use of this website and the Trade Marks displayed, in compliance with the provisions of the Trademark Act, 1999, Section 30 and 30(1) under 'Fair use.'
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Back to Listing