Suppliers / PMC Isochem

PMC Isochem

France Updated 9 July 2026

PMC Isochem is an API manufacturer based in France. It holds 33 active US drug master files across a filed portfolio of 11 molecules. Its GMP standing is certified by ANSM (FR) and US FDA. Its most recent recorded inspection, by US FDA, closed on 17 November 2023 as VAI.

33
active US DMFs
0
valid CEPs
6
registered plants 2 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 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 November 2023 VAI US FDA
  • 24 February 2022 VAI US FDA
  • 6 March 2020 VAI US FDA
  • 8 February 2018 VAI US FDA
  • 17 February 2017 VAI US FDA
  • 28 May 2014 NAI US FDA
  • 27 July 2011 NAI US FDA
  • 21 July 2011 NAI US FDA

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

Registered plants

Site FDA FEI
VERT LE PETIT, France Not on file
France, France 3002807312
France, France 3003955453
Vert Le Petit, France Not on file
Pithiviers, France Not on file
Gennevilliers, France Not on file

What they file, and where

Molecule Regulators Docs
Acetohydroxamic Acid US FDA 3
Amiodarone US FDA 3
Diosmin US FDA 3
Domiphen US FDA 3
Econazole US FDA 3
Indoramin US FDA 3
Loperamide US FDA 3
Nefopam US FDA 3
Pantoprazole US FDA 3
Tocofersolan US FDA 3
Show all 11 molecules on file
Trimebutine US FDA 3

Also appears on these molecule pages

Amiodarone API Dimethyl contract manufacturing Diosmin API Econazole API Loperamide API Nefopam API Trimebutine API Pantoprazole API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 1 None
ANSM (FR) None 42
US FDA None 1

Questions about PMC Isochem

Does PMC Isochem hold a US DMF or a CEP?
PMC Isochem holds 33 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 PMC Isochem FDA-registered?
2 sites operated by PMC Isochem carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did PMC Isochem's last inspection go?
The most recent inspection on record closed on 17 November 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does PMC Isochem manufacture?
6 registered sites are on record, in France (Vert LE Petit, France and Vert Le Petit among others). Every site is listed on this page with the register it came from.
What does PMC Isochem make?
11 molecules are on record against PMC Isochem, including Acetohydroxamic Acid, Amiodarone, Diosmin and Domiphen. Each links through to that molecule's full manufacturer list.
Which regulators recognise PMC Isochem's GMP?
Current GMP certificates are on record from ANSM (FR) and US FDA. 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.

Comparing suppliers?

Choose your molecules and target markets. PMC Isochem comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was VAI, on 17 November 2023.

Comparable suppliers

Olon shares 3 molecules Janssen Pharmaceutica shares 2 molecules Hainan Poly Pharm shares 2 molecules Alivus Life Sciences shares 1 molecule Cambrex Profarmaco Milano shares 1 molecule

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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