Baxalta Belgium Manufacturing SA

Lessines, BelgiumFEI 3002806503API manufacture registered

Baxalta Belgium Manufacturing SA is a drug establishment in Lessines, Belgium, registered with the US FDA under FEI 3002806503. Its registered operations are: Analytical testing, API manufacture, Labelling, Drug manufacture, Packaging. 10 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 manufactureLabellingDrug manufacturePackaging

GMP documents matched to this site (10)

DocumentAuthorityInspectionSource
BE/GMP/2026/087
GMP certificate
Competent authority of Belgium19 Jun 2026
within 3-year review window
EudraGMDP
BE/GMP/2026/086
GMP certificate
Competent authority of Belgium19 Jun 2026
within 3-year review window
EudraGMDP
BE/GMP/2025/161
GMP certificate
Competent authority of Belgium28 Nov 2025
within 3-year review window
EudraGMDP
BE/GMP/2025/162
GMP certificate
Competent authority of Belgium28 Nov 2025
within 3-year review window
EudraGMDP
BE/GMP/2024/078
GMP certificate
Competent authority of Belgium8 Jul 2024
within 3-year review window
EudraGMDP
BE/GMP/2024/059
GMP certificate
Competent authority of Belgium8 Jul 2024
within 3-year review window
EudraGMDP
BE/GMP/2023/051
GMP certificate
Competent authority of Belgium23 Jun 2023
outside 3-year review window
EudraGMDP
BE/GMP/2023/050
GMP certificate
Competent authority of Belgium23 Jun 2023
outside 3-year review window
EudraGMDP
BE/GMP/2020/106
GMP certificate
Competent authority of Belgium17 Dec 2020
outside 3-year review window
EudraGMDP
BE/GMP/2020/105
GMP certificate
Competent authority of Belgium17 Dec 2020
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