Organon & Co.

Jersey City, New Jersey, United States organon.com

Overview

Organon & Co. is a global healthcare company dedicated to improving the health of women throughout their lives. It was spun off from Merck & Co., Inc. in 2021. The company focuses on the innovation of women’s health solutions and provides a wide range of therapies in reproductive health, heart disease, and more.

Therapeutic areas

Women's HealthBiosimilarsEstablished Brands

Active pharmaceutical ingredients supplied

Substances Organon & Co. is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.

HeparinDexamethasoneEstradiolNorethindroneMegestrol AcetateOxandroloneEthinyl EstradiolPyridostigmine BromideFluphenazine DecanoateNaltrexonePrasteroneDanazolPrednisolone Sodium PhosphatePimozideTestosterone PropionateFentanyl CitrateNalmefene HydrochlorideDroperidolNorgestimateMestranolButorphanol TartrateEstradiol BenzoateEstriolProchlorperazine EdisylateEstropipateDexamethasone AcetateNalbuphine HydrochlorideEdrophonium ChlorideEstrogens, ConjugatedStanoloneTubocurarine ChlorideNorgestometTibolone2-METHOXYESTRADIOL

API / Drug Master Files

Organon & Co. holds 0 active (56 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

  • 2-METHOXYESTRADIOLInactive2007-09-06
  • 16-ALPHA-HYDROXYPREDNISOLONE (INTERMEDIATE)Inactive2006-06-07
  • NORGESTIMATEInactive2006-04-06
  • FENTANYL CITRATEInactive2006-01-03
  • NALTREXONEInactive2004-07-20
  • OXANDROLONEInactive2004-06-09
  • ANDROSTANOLONEInactive2003-10-15
  • ESTERIFIED ESTROGENS TYPE BAInactive2002-12-06
  • HEPARIN SODIUM IIIInactive2002-11-11
  • ESTRADIOL BENZOATEInactive2000-10-11
  • DEHYDROISOANDROSTERONE POLYMORPH IInactive1999-07-12
  • TIBOLONEInactive1998-12-14
  • PORCINE INSULIN HIGHLY PURIFIEDInactive1998-07-27
  • NORGESTOMETInactive1997-01-23
  • MEGESTROL ACETATEInactive1996-10-02

Showing 15 of 56 Drug Master Files.

FDA compliance signals

3 FDA enforcement records linked to this company.

  • recall — Class III2024-06-19

    Defective Container

  • recall — Class III2024-06-19

    Defective Container

  • recall — Class III2024-06-19

    Defective Container

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