Posaconazole Tablets

Form: Delayed-Release Tablets

Strength: 300 mg

Reference Brands: Noxafil(US & EU)

Category: Anti-fungal

Posaconazole delayed-release tablets are approved in the EU and US for prophylaxis and treatment of invasive fungal infections. In the EU, MSD’s Noxafil is regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval is based on comprehensive clinical data, biosimilarity assessments, and ongoing pharmacovigilance. Both regions require detailed regulatory dossiers for initial approval and continuous safety monitoring. For expert assistance with dossiers, regulatory submissions, and compliance, visit PharmaTradz, your trusted partner in pharmaceutical regulatory solutions. We facilitate efficient market access for posaconazole delayed-release tablets, ensuring adherence to European and American standards for safe, effective antifungal therapy.