Isotretinoin

CAS 4759-48-2 7 FDA-DMF suppliersSmall Molecule

Overview

Isotretinoin is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL547).

API suppliers (9)

Suppliers of Isotretinoin backed by a verifiable FDA Type II Drug Master File. Source: FDA quarterly DMF list.

  • CHONGQING CARELIFE PHARMACEUTICAL CO LTDChina2 active DMF
  • Sun Pharmaceutical Industries LimitedIndia1 active DMF
  • Sun Pharmaceutical Industries LimitedIndia1 active DMF
  • Sun Pharmaceutical Industries LimitedIndia1 active DMF
  • HAS Healthcare Advanced Synthesis SASwitzerland1 active DMF
  • Sun Pharmaceutical Industries LimitedIndia1 active DMF
  • OLON SPAItaly1 active DMF
  • HAS Healthcare Advanced Synthesis SASwitzerland1 active DMF
  • Ipca Laboratories LimitedIndia

Patent & exclusivity (US)

Per the FDA Orange Book (56 approved US products), the latest listed US patent on Isotretinoin expires 3 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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