Ketoconazole Tablets Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 200 mg

Reference Brands: Nizoral(US & EU)

Category: Anti-fungal

Ketoconazole Tablets is available in Tablets and strengths such as 200 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, Ketoconazole Tablets is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Ketoconazole Tablets 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: Ketoconazole tablets are approved in the EU and US for treating systemic fungal infections. In the EU, Janssen’s Nizoral tablets are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, the FDA-approved Nizoral and generic versions are based on comprehensive clinical data, biosimilarity assessments, and ongoing pharmacovigilance. Both regions require detailed regulatory dossiers for approval and post-marketing safety monitoring. For expert assistance with pharmaceutical dossiers, regulatory submissions, and compliance, visit PharmaTradz, your trusted partner in regulatory solutions, ensuring smooth market access and ongoing adherence to regulatory standards for ketoconazole tablets.