Norgestrel

6 FDA-DMF suppliersSmall Molecule

Overview

Norgestrel is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL2107797).

API suppliers (6)

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

  • Gedeon RichterHungary2 active DMF
  • STERLING SPAItaly1 active DMF
  • HUNAN DONGTING PHARMACEUTICAL CO LTDChina1 active DMF
  • Bayer AGGermany1 active DMF
  • Lupin LimitedIndia1 active DMF
  • SCINOPHARM TAIWAN LTDTaiwan

Patent & exclusivity (US)

Per the FDA Orange Book (1 approved US product), the latest listed US patent on Norgestrel expires — and exclusivity 13 Jul 2026. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name
(8R,9S,10R,13S,14S)-13-ethyl-17-ethynyl-17-hydroxy-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-3-one
Canonical SMILES
CC[C@]12CC[C@H]3[C@H]([C@@H]1CCC2(C#C)O)CCC4=CC(=O)CC[C@H]34
InChIKey
WWYNJERNGUHSAO-CULCCENASA-N

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