Fingolimod Hydrochloride

Overview

Fingolimod Hydrochloride is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL544665).

API suppliers (21)

Suppliers of Fingolimod Hydrochloride 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
• Zydus Lifesciences LimitedIndia1 active DMF GMP on record
• Intas Pharmaceuticals Ltd.India1 active DMF GMP on record
• NOVUGEN PHARMA MALAYSIA SDN BHD1 active DMF
• SHILPA PHARMA LIFESCIENCES LTDIndia1 active DMF
• RUYUAN HEC PHARM CO LTD1 active DMF
• ALIVUS LIFE SCIENCES LTDIndia1 active DMF GMP on record
• MATRIX PHARMACORP PRIVATE LTDIndia1 active DMF
• Apotex Pharmachem India Pvt. Ltd.India1 active DMF
• Alembic Pharmaceuticals LimitedIndia1 active DMF GMP on record
• TAI HENG INDUSTRY CO LTD1 active DMF
• TAPI NL BVNetherlands1 active DMF
• HONOUR LAB LTDIndia1 active DMF GMP on record
• Emcure Pharmaceuticals LimitedIndia1 active DMF GMP on record
• Biocon LimitedIndia1 active DMF
• Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
• MAPRIMED SAArgentina1 active DMF GMP on record
• Zhejiang Huahai Pharmaceutical Co., Ltd.China1 active DMF GMP on record
• DR REDDYS LABORATORIES LTD GMP on record
• Deva Holding A.Ş.TurkeyCEP
• MSN Laboratories Private LimitedIndiaCEP GMP on record

EU CEP holders (9)

Companies holding a valid EU Certificate of Suitability (CEP) for Fingolimod Hydrochloride, 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 (17 approved US products), the latest listed US patent on Fingolimod Hydrochloride expires 30 Sept 2032. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol;hydrochloride

Canonical SMILES

CCCCCCCCC1=CC=C(C=C1)CCC(CO)(CO)N.Cl

InChIKey

SWZTYAVBMYWFGS-UHFFFAOYSA-N