Itraconazole

Overview

Itraconazole is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL64391).

API suppliers (14)

Suppliers of Itraconazole evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.

• SMS Pharmaceuticals limitedIndia1 active DMF GMP on record
• VASUDHA PHARMA CHEM LTDIndia1 active DMF
• LEE PHARMA LTDIndia1 active DMF GMP on record
• ALIVUS LIFE SCIENCES LTDIndia1 active DMF GMP on record
• COHANCE LIFESCIENCES LTDIndia1 active DMF GMP on record
• Neuland Laboratories LimitedIndia1 active DMF
• QUIMICA SINTETICA SASpain1 active DMF GMP on record
• W R GRACE AND CO -CONNUnited States1 active DMF
• MATRIX PHARMACORP PRIVATE LTDIndia1 active DMF
• SOCIETA ITALIANA MEDICINALI SCANDICCI
• QUIMICA FINA FARMEX SA DE CV
• Hetero Drugs LimitedIndia GMP on record
• PIRAMAL HEALTHCARE LTD
• APOTECNIA SA

EU CEP holders (7)

Companies holding a valid EU Certificate of Suitability (CEP) for Itraconazole, from the EDQM certification database. A CEP holder is a documented EU-market source of the substance — not necessarily the manufacturer — and these are not yet profiled in our directory.

Patent & exclusivity (US)

Per the FDA Orange Book (11 approved US products), the latest listed US patent on Itraconazole expires 21 Jun 2033. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

2-butan-2-yl-4-[4-[4-[4-[[2-(2,4-dichlorophenyl)-2-(1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-1,2,4-triazol-3-one

Canonical SMILES

CCC(C)N1C(=O)N(C=N1)C2=CC=C(C=C2)N3CCN(CC3)C4=CC=C(C=C4)OCC5COC(O5)(CN6C=NC=N6)C7=C(C=C(C=C7)Cl)Cl

InChIKey

VHVPQPYKVGDNFY-UHFFFAOYSA-N