Fresenius Kabi AB

Uppsala, SwedenFEI 3002631703API manufacture registered

Fresenius Kabi AB is a drug establishment in Uppsala, Sweden, registered with the US FDA under FEI 3002631703. Its registered operations are: Analytical testing, API manufacture, Drug manufacture. 9 EU/UK GMP certificates are matched to this site, 6 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 (9)

DocumentAuthorityInspectionSource
SE-H-API-25-106059
GMP certificate
Competent authority of Sweden19 Mar 2026
within 3-year review window
EudraGMDP
SE-V-GMP-25-032522
GMP certificate
Competent authority of Sweden24 Jan 2025
within 3-year review window
EudraGMDP
SE-HI-GMP-25-032528
GMP certificate
Competent authority of Sweden24 Jan 2025
within 3-year review window
EudraGMDP
SE-H-GMP-25-032513
GMP certificate
Competent authority of Sweden24 Jan 2025
within 3-year review window
EudraGMDP
SE-H-GMP-24-060321
GMP certificate
Competent authority of Sweden2 May 2024
within 3-year review window
EudraGMDP
SE-V-GMP-24-060654
GMP certificate
Competent authority of Sweden2 May 2024
within 3-year review window
EudraGMDP
SE-H-API-23-061069
GMP certificate
Competent authority of Sweden21 Sept 2023
outside 3-year review window
EudraGMDP
SE-HI-GMP-25-015526
GMP certificate
Competent authority of Sweden21 Apr 2023
outside 3-year review window
EudraGMDP
6.2.1-2019-028920
GMP certificate
Competent authority of Sweden23 May 2019
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.