Teriflunomide

Overview

Teriflunomide is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL973).

API suppliers (18)

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

• Alembic Pharmaceuticals LimitedIndia1 active DMF GMP on record
• ALIVUS LIFE SCIENCES LTDIndia1 active DMF GMP on record
• PHARMAZELL GMBHGermany1 active DMF GMP on record
• RAKS PHARMA PVT LTDIndia1 active DMF
• Formosa Laboratories, Inc.Taiwan1 active DMF GMP on record
• Tianjin Weijie Pharmaceutical Co., Ltd.China1 active DMF
• Biocon LimitedIndia1 active DMF
• APITORIA PHARMA PRIVATE LTDIndia1 active DMF GMP on record
• OLON SPAItaly1 active DMF GMP on record
• Emcure Pharmaceuticals LimitedIndia1 active DMF GMP on record
• Zydus Lifesciences LimitedIndia1 active DMF GMP on record
• Intas Pharmaceuticals Ltd.India1 active DMF GMP on record
• Natco Pharma Usa1 active DMF
• SHILPA PHARMA LIFESCIENCES LTDIndia1 active DMF
• OPTIMUS DRUGS PRIVATE LTDIndia1 active DMF
• MAPRIMED SAArgentina1 active DMF GMP on record
• HONOUR LAB LTDIndia1 active DMF GMP on record
• Unichem Laboratories Ltd.India1 active DMF GMP on record

EU CEP holders (14)

Companies holding a valid EU Certificate of Suitability (CEP) for Teriflunomide, 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 (28 approved US products), the latest listed US patent on Teriflunomide expires 4 Aug 2034. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

(Z)-2-cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]but-2-enamide

Canonical SMILES

C/C(=C(\C#N)/C(=O)NC1=CC=C(C=C1)C(F)(F)F)/O

InChIKey

UTNUDOFZCWSZMS-YFHOEESVSA-N