Isotretinoin
Overview
Isotretinoin is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL547).
API suppliers (8)
Suppliers of Isotretinoin 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 6 of 8 suppliers.
5 of 8 hold a GMP certificate on record in the EU or UK registers · 1 holds a European CEP for this substance
- CHONGQING HUAPONT PHARMACEUTICAL CO LTD2 active DMF
- Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
- BIOPHORE INDIA PHARMACEUTICALS PVT LTD1 active DMF
- HAS Healthcare Advanced Synthesis SASwitzerland1 active DMF GMP on record
- OLON SPAItaly1 active DMF GMP on record
- Hetero Drugs LimitedIndia1 active DMF GMP on record
- SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBHGermanyCEP
- Ipca Laboratories LimitedIndia GMP on record
Patent & exclusivity (US)
Per the FDA Orange Book (56 approved US products), the latest listed US patent on Isotretinoin expires 4 Aug 2035. Generic API sourcing typically opens up once these lapse.
Chemical identity
- IUPAC name
- (2Z,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid
- Canonical SMILES
- CC1=C(C(CCC1)(C)C)/C=C/C(=C/C=C/C(=C\C(=O)O)/C)/C
- InChIKey
- SHGAZHPCJJPHSC-XFYACQKRSA-N
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