Suppliers / Zach System

Zach System

France 146 employees Updated 9 July 2026

Zach System is an API manufacturer based in France. It holds 3 active US drug master files and 3 valid CEPs across a filed portfolio of 7 molecules. Its GMP standing is certified by ANSM (FR). Its most recent recorded inspection, by US FDA, closed on 12 February 2021 as VAI.

3
active US DMFs
3
valid CEPs
4
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
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 12 February 2021 VAI US FDA
  • 7 December 2017 VAI US FDA
  • 16 October 2014 NAI US FDA
  • 2 December 2010 NAI US FDA
  • 11 June 2009 OAI US FDA

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

Registered plants

Site FDA FEI
Avrillé, France Not on file
France, France 3002808164
AVRILLE, France Not on file
Avrille, France Not on file

What they file, and where

Molecule Regulators Docs
Bosentan SFDA (Saudi Arabia), US FDA 2
Loteprednol Etabonate SFDA (Saudi Arabia), US FDA 2
Abiraterone US FDA 1
Acetylcysteine EDQM 1
Fosfomycin EDQM 1
Gabapentin SFDA (Saudi Arabia) 1
Trimebutine EDQM 1

Also appears on these molecule pages

Acetylcysteine API Gabapentin API

Filings and GMP by regulator

Regulator Filings GMP certificates
ANSM (FR) None 16

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Open risk flags

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was VAI, on 12 February 2021.

Sources on this page

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