Varenicline

CAS 249296-44-4 22 FDA-DMF suppliersSmall Molecule

Overview

Varenicline is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL1076903).

API suppliers (11)

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

  • TAPI NL BV1 active DMF
  • APOTEX PHARMACHEM INC1 active DMF
  • Lupin LimitedIndia1 active DMF
  • Lupin LimitedIndia1 active DMF
  • MATRIX PHARMACORP PRIVATE LTD1 active DMF
  • TAPI NL BV1 active DMF
  • MEDICHEM SASpain1 active DMF
  • APOTEX PHARMACHEM INC1 active DMF
  • ACTAVIS GROUP PTC EHFIceland1 active DMF
  • Zhejiang Hisun Pharmaceutical Co., Ltd.China
  • Pharmaron Beijing Co., Ltd.China

Patent & exclusivity (US)

Per the FDA Orange Book (42 approved US products), the latest listed US patent on Varenicline expires 18 Oct 2035. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name
(1S,12R)-5,8,14-triazatetracyclo[10.3.1.02,11.04,9]hexadeca-2,4,6,8,10-pentaene
Canonical SMILES
C1[C@@H]2CNC[C@H]1C3=CC4=NC=CN=C4C=C23
InChIKey
JQSHBVHOMNKWFT-DTORHVGOSA-N

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