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

Abiraterone API Acetylcysteine API Bosentan API Fosfomycin API Loteprednol Etabonate API Trimebutine API Gabapentin API

Filings and GMP by regulator

Regulator Filings GMP certificates
ANSM (FR) None 16

Questions about Zach System

Does Zach System hold a US DMF or a CEP?
Zach System holds 3 active US drug master files and 3 valid CEPs. 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 Zach System FDA-registered?
One site operated by Zach System 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 Zach System's last inspection go?
The most recent inspection on record closed on 12 February 2021 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file, of which 1 closed as OAI.
Where does Zach System manufacture?
4 registered sites are on record, in France (Avrillé, France and Avrille among others). Every site is listed on this page with the register it came from.
What does Zach System make?
7 molecules are on record against Zach System, including Bosentan, Loteprednol Etabonate, Abiraterone and Acetylcysteine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zach System'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

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

Comparable suppliers

MSN Laboratories shares 2 molecules Apitoria Pharma shares 2 molecules Cipla shares 2 molecules Honour Lab shares 2 molecules Moehs shares 2 molecules

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