GlaxoSmithKline Biologicals SA

Wavre, BelgiumFEI 3003973577

GlaxoSmithKline Biologicals SA is a drug establishment in Wavre, Belgium, registered with the US FDA under FEI 3003973577. Its registered operations are: Analytical testing, Labelling, Drug manufacture, Packaging, Sterilisation. 18 EU/UK GMP certificates are matched to this site, 17 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 testingLabellingDrug manufacturePackagingSterilisation

GMP documents matched to this site (18)

DocumentAuthorityInspectionSource
BE/GMP/2026/056
GMP certificate
Competent authority of Belgium2 Jun 2026
within 3-year review window
EudraGMDP
BE/GMP/2026/021
GMP certificate
Competent authority of Belgium6 Mar 2026
within 3-year review window
EudraGMDP
BE/GMP/2026/020
GMP certificate
Competent authority of Belgium6 Mar 2026
within 3-year review window
EudraGMDP
BE/GMP/2025/174
GMP certificate
Competent authority of Belgium5 Nov 2025
within 3-year review window
EudraGMDP
BE/GMP/2025/117
GMP certificate
Competent authority of Belgium17 Oct 2025
within 3-year review window
EudraGMDP
BE/GMP/2025/159
GMP certificate
Competent authority of Belgium12 Sept 2025
within 3-year review window
EudraGMDP
BE/GMP/2025/100
GMP certificate
Competent authority of Belgium12 Sept 2025
within 3-year review window
EudraGMDP
BE/GMP/2025/048
GMP certificate
Competent authority of Belgium23 May 2025
within 3-year review window
EudraGMDP
BE/GMP/2025/031
GMP certificate
Competent authority of Belgium21 Jan 2025
within 3-year review window
EudraGMDP
BE/GMP/2024/128
GMP certificate
Competent authority of Belgium20 Sept 2024
within 3-year review window
EudraGMDP
BE/GMP/2024/074
GMP certificate
Competent authority of Belgium5 Jul 2024
within 3-year review window
EudraGMDP
BE/GMP/2024/073
GMP certificate
Competent authority of Belgium5 Jul 2024
within 3-year review window
EudraGMDP
BE/GMP/2024/165
GMP certificate
Competent authority of Belgium5 Jun 2024
within 3-year review window
EudraGMDP
BE/GMP/2024/166
GMP certificate
Competent authority of Belgium5 Jun 2024
within 3-year review window
EudraGMDP
BE/GMP/2024/025
GMP certificate
Competent authority of Belgium21 Mar 2024
within 3-year review window
EudraGMDP
BE/GMP/2024/034
GMP certificate
Competent authority of Belgium20 Feb 2024
within 3-year review window
EudraGMDP
BE/GMP/2023/118
GMP certificate
Competent authority of Belgium8 Nov 2023
within 3-year review window
EudraGMDP
BE/GMP/2023/087
GMP certificate
Competent authority of Belgium19 Oct 2023
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.

Other sites registered by the same company