ZACH SYSTEM S.A.

AVRILLE, FranceFEI 3002808164API manufacture registered

ZACH SYSTEM S.A. is a drug establishment in AVRILLE, France, registered with the US FDA under FEI 3002808164. Its registered operations are: API manufacture. 5 EU/UK GMP certificates are matched to this site, 2 inspected within the last three years.

Sources: FDA Drug Establishments Current Registration Site (checked 2 Nov 2026); EudraGMDP; MHRA GMDP. Methodology

Registered operations

Business operations this establishment declares in its FDA registration. Registration is not an approval and says nothing about EU or UK GMP status.

API manufacture

GMP documents matched to this site (5)

DocumentAuthorityInspectionSource
25MPP019VFR01
GMP certificate
Competent authority of France11 Apr 2025
within 3-year review window
EudraGMDP
25MPP019HFR01
GMP certificate
Competent authority of France11 Apr 2025
within 3-year review window
EudraGMDP
21MPP009VFR02
GMP certificate
Competent authority of France12 Feb 2021
outside 3-year review window
EudraGMDP
21MPP009VFR03
GMP certificate
Competent authority of France12 Feb 2021
outside 3-year review window
EudraGMDP
21MPP009HFR03
GMP certificate
Competent authority of France12 Feb 2021
outside 3-year review window
EudraGMDP

A GMP document is matched to this site when its address names the site's street and its city or postcode. In our latest internal review 59 of 60 sampled matches were the right site (not yet independently reviewed; measured match quality). Check the certificate's own address before relying on it. The three-year review window is the EMA guideline default after an inspection, not an official expiry date.

What this page does not show

  • Which substances are made here: DMFs and CEPs are filed by organisations, not sites, so we do not link substances to this site.
  • Capacity, scale, price or current availability: no regulator publishes these.
  • FDA inspection classifications for this site, which are not yet linked.