Safinamide
Overview
Safinamide is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL396778).
API suppliers (4)
Suppliers of Safinamide evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.
Country recorded for 3 of 4 suppliers.
2 of 4 hold a GMP certificate on record in the EU or UK registers
- FIS FABBRICA ITALIANA SINTETICI SPAItaly1 active DMF GMP on record
- ZAKLADY FARMACEUTYCZNE POLPHARMA SA1 active DMF
- MSN LIFE SCIENCES PRIVATE LIMITEDIndia1 active DMF GMP on record
- Merck KGaAGermany
Patent & exclusivity (US)
Per the FDA Orange Book (8 approved US products), the latest listed US patent on Safinamide expires 21 Mar 2031. Generic API sourcing typically opens up once these lapse.
Chemical identity
- IUPAC name
- (2S)-2-[[4-[(3-fluorophenyl)methoxy]phenyl]methylamino]propanamide
- Canonical SMILES
- C[C@@H](C(=O)N)NCC1=CC=C(C=C1)OCC2=CC(=CC=C2)F
- InChIKey
- NEMGRZFTLSKBAP-LBPRGKRZSA-N
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