Sapropterin
Overview
Sapropterin is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL1201774).
API suppliers (3)
Suppliers of Sapropterin 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 2 of 3 suppliers.
1 of 3 holds a GMP certificate on record in the EU or UK registers
- Asymchem Laboratories (Tianjin) Co., Ltd.China1 active DMF
- DIPHARMA SASwitzerland1 active DMF GMP on record
- SHIRATORI PHARMCEUTICAL CO LTD
Patent & exclusivity (US)
Per the FDA Orange Book (20 approved US products), the latest listed US patent on Sapropterin expires 1 May 2033. Generic API sourcing typically opens up once these lapse.
Chemical identity
- IUPAC name
- (6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro-1H-pteridin-4-one
- Canonical SMILES
- C[C@@H]([C@@H]([C@H]1CNC2=C(N1)C(=O)N=C(N2)N)O)O
- InChIKey
- FNKQXYHWGSIFBK-RPDRRWSUSA-N
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