Dexamethasone

CAS 50-02-2 19 API suppliersSmall Molecule

Overview

Dexamethasone is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL384467).

API suppliers (19)

Suppliers of Dexamethasone evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.

Where these suppliers are
India2Italy1France1China1

Country recorded for 5 of 19 suppliers.

2 of 19 hold a GMP certificate on record in the EU or UK registers

  • PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INC3 active DMF
  • FARMABIOS SPAItaly2 active DMF
  • SYMBIOTEC PHARMALAB PRIVATE LTDIndia2 active DMF GMP on record
  • EUROAPI FRANCEFrance2 active DMF GMP on record
  • TIANJIN TIANYAO PHARMACEUTICALS CO LTDChina1 active DMF
  • ZHEJIANG XIANJU PHARMACEUTICAL CO LTD1 active DMF
  • MAHIMA LIFE SCIENCES PRIVATE LTDIndia1 active DMF
  • SHANDONG SIRUI PHARMACEUTICAL CO LTD1 active DMF
  • XIAN GUOKANG RUIJIN PHARMACEUTICAL CO LTD1 active DMF
  • SF DURST AND CO INC
  • ANTIBIOTICOS SPA
  • ROUSSEL CORP
  • Organon Usa Inc
  • BLASCHIM SPA
  • CYCLO PRODUCTS INC
  • DIOSYNTH BV
  • SOCIETA ITALIANA CORTICOSTEROIDI SPA
  • COMPANIA ESPANOLA DE SINTESIS QUIMICA SA
  • HOECHST MARION ROUSSEL SA

EU CEP holders (3)

Companies holding a valid EU Certificate of Suitability (CEP) for Dexamethasone, from the EDQM certification database. A CEP holder is a documented EU-market source of the substance — not necessarily the manufacturer — and these are not yet profiled in our directory.

BHAGERIA & JAJODIA PHARMACEUTICALS PRIVATE LIMITED VapiINSHANDONG SIRUI PHARMACEUTICAL CO., LTD. HezeCNTIANJIN TIANYAO PHARMACEUTICALS CO., LTD. TianjinCN

Patent & exclusivity (US)

Per the FDA Orange Book (75 approved US products), the latest listed US patent on Dexamethasone expires 26 Apr 2041 and exclusivity 7 Apr 2028. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name
(8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoro-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one
Canonical SMILES
C[C@@H]1C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@@]4([C@]3([C@H](C[C@@]2([C@]1(C(=O)CO)O)C)O)F)C
InChIKey
UREBDLICKHMUKA-CXSFZGCWSA-N
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