Suppliers / Orgapharm Sas

Orgapharm Sas

France Updated 9 July 2026

Orgapharm Sas is an API manufacturer based in France. It holds 5 active US drug master files across a filed portfolio of 6 molecules. Its GMP standing is certified by ANSM (FR). Its most recent recorded inspection, by US FDA, closed on 17 March 2022 as VAI.

5
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 17 March 2022 VAI US FDA
  • 7 June 2018 NAI US FDA
  • 9 September 2016 NAI US FDA
  • 23 May 2014 VAI US FDA
  • 9 April 2014 VAI US FDA
  • 8 December 2011 VAI US FDA
  • 17 September 2010 VAI US FDA
  • 11 June 2009 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Pithiviers, France Not on file
France, France 3002807503

What they file, and where

Molecule Regulators Docs
Articaine US FDA 1
Ethionamide US FDA 1
Hemoporfin US FDA 1
Methylene Blue SFDA (Saudi Arabia) 1
Protoporphyrin US FDA 1
Thiothixene US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
ANSM (FR) None 26

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Open risk flags

  • The most recent inspection outcome was VAI, on 17 March 2022.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates