Dronedarone

Overview

Dronedarone is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL184412).

API suppliers (8)

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

• MSN Laboratories Private LimitedIndia2 active DMF GMP on record
• ALIVUS LIFE SCIENCES LTDIndia1 active DMF GMP on record
• CHEMWERTH INCFrance1 active DMF
• LUPIN MANUFACTURING SOLUTIONS LTD1 active DMF
• RAKS PHARMA PVT LTDIndia1 active DMF
• APITORIA PHARMA PRIVATE LTDIndia1 active DMF GMP on record
• Alembic Pharmaceuticals LimitedIndia1 active DMF GMP on record
• AURORE LIFE SCIENCES PRIVATE LTD1 active DMF GMP on record

Patent & exclusivity (US)

Per the FDA Orange Book (1 approved US product), the latest listed US patent on Dronedarone expires 30 Jun 2031. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-1-benzofuran-5-yl]methanesulfonamide

Canonical SMILES

CCCCC1=C(C2=C(O1)C=CC(=C2)NS(=O)(=O)C)C(=O)C3=CC=C(C=C3)OCCCN(CCCC)CCCC

InChIKey

ZQTNQVWKHCQYLQ-UHFFFAOYSA-N