AGC Biologics SPA

Bresso, ItalyFEI 3020270660API manufacture registered

AGC Biologics SPA is a drug establishment in Bresso, Italy, registered with the US FDA under FEI 3020270660. Its registered operations are: Analytical testing, API manufacture, Drug manufacture. 7 EU/UK GMP certificates are matched to this site, 4 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.

Analytical testingAPI manufactureDrug manufacture

GMP documents matched to this site (7)

DocumentAuthorityInspectionSource
IT/124/H/2026
GMP certificate
Competent authority of Italy14 May 2026
within 3-year review window
EudraGMDP
IT/123/H/2026
GMP certificate
Competent authority of Italy14 May 2026
within 3-year review window
EudraGMDP
IT/54/H/2026
GMP certificate
Competent authority of Italy23 Oct 2025
within 3-year review window
EudraGMDP
IT/210/H/2025
GMP certificate
Competent authority of Italy23 Oct 2025
within 3-year review window
EudraGMDP
IT/157/H/2023
GMP certificate
Competent authority of Italy2 Dec 2022
outside 3-year review window
EudraGMDP
IT/231/H/2024
GMP certificate
Competent authority of Italy2 Dec 2022
outside 3-year review window
EudraGMDP
IT/92/H/2025
GMP certificate
Competent authority of Italy2 Dec 2022
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.