Isavuconazole High-purity API Suppliers & Bulk Manufacturers

Available Forms: White to off-white crystalline powder

Available Strengths: High-purity API

Reference Brands: Cresemba (US/EU)

Category: Active Pharmaceutical Ingredient

Isavuconazole API, a white to off-white crystalline triazole antifungal powder for formulation, development and reference work. For finished-dose manufacturers and API buyers who need full GMP and impurity documentation.

Product Description:

Isavuconazole is a broad-spectrum triazole antifungal. Like other azoles, it inhibits lanosterol 14-alpha-demethylase, the fungal cytochrome P450 enzyme that makes ergosterol, so the cell membrane loses integrity. This page offers the API as a white to off-white crystalline powder. The finished capsules and infusion vials use isavuconazonium sulfate, a water-soluble prodrug that plasma esterases rapidly convert to isavuconazole, which allows an IV form without a cyclodextrin carrier. Confirm whether you need the prodrug salt or the active moiety.

The finished products are prescription-only hospital medicines for invasive aspergillosis and mucormycosis, the latter in the EU where amphotericin B is unsuitable. They are given orally or by infusion. Isavuconazole is contraindicated with strong CYP3A4 inhibitors and inducers and in familial short QT syndrome, as it shortens QT. Doses are expressed as isavuconazole, so the prodrug salt factor must enter every formula and assay calculation.

Sourcing notes. Ask for the open part of the DMF or ASMF, a synthesis route outline and evidence of ICH Q7 GMP. Check whether a pharmacopoeial monograph applies in your market; otherwise the specification rests on validated in-house methods. Key points are assay, related substances, stereoisomeric purity since the molecule has two chiral centres, residual solvents to ICH Q3C, elemental impurities to ICH Q3D, water and particle size. Regulators now expect a nitrosamine risk assessment for every API. Request a batch CoA, retest period with stability data, the safety data sheet, and sealed liners in drums protected from light and moisture.