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

Articaine API Ethionamide API Methylene Blue API

Filings and GMP by regulator

Regulator Filings GMP certificates
ANSM (FR) None 26

Questions about Orgapharm Sas

Does Orgapharm Sas hold a US DMF or a CEP?
Orgapharm Sas holds 5 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Orgapharm Sas FDA-registered?
One site operated by Orgapharm Sas carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Orgapharm Sas's last inspection go?
The most recent inspection on record closed on 17 March 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Orgapharm Sas manufacture?
2 registered sites are on record, in France (Pithiviers and France). Every site is listed on this page with the register it came from.
What does Orgapharm Sas make?
6 molecules are on record against Orgapharm Sas, including Articaine, Ethionamide, Hemoporfin and Methylene Blue. Each links through to that molecule's full manufacturer list.
Which regulators recognise Orgapharm Sas's GMP?
Current GMP certificates are on record from ANSM (FR). GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

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

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Sources on this page

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