Baxter SA
Baxter SA is a drug establishment in Lessines, Belgium, registered with the US FDA under FEI 3005468265. Its registered operations are: Analytical testing, Labelling, Drug manufacture, Packaging, Sterilisation. 9 EU/UK GMP certificates are matched to this site, 7 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.
GMP documents matched to this site (9)
| Document | Authority | Inspection | Source |
|---|---|---|---|
BE/GMP/2025/140 GMP certificate | Competent authority of Belgium | 3 Oct 2025 within 3-year review window | EudraGMDP |
BE/GMP/2025/139 GMP certificate | Competent authority of Belgium | 3 Oct 2025 within 3-year review window | EudraGMDP |
BE/GMP/2024/125 GMP certificate | Competent authority of Belgium | 14 Jun 2024 within 3-year review window | EudraGMDP |
BE/GMP/2024/126 GMP certificate | Competent authority of Belgium | 14 Jun 2024 within 3-year review window | EudraGMDP |
BE/GMP/2024/094 GMP certificate | Competent authority of Belgium | 14 Jun 2024 within 3-year review window | EudraGMDP |
BE/GMP/2023/104 GMP certificate | Competent authority of Belgium | 17 Nov 2023 within 3-year review window | EudraGMDP |
BE/GMP/2023/105 GMP certificate | Competent authority of Belgium | 17 Nov 2023 within 3-year review window | EudraGMDP |
BE/GMP/2021/147 GMP certificate | Competent authority of Belgium | 6 Oct 2021 outside 3-year review window | EudraGMDP |
BE/GMP/2020/127 GMP certificate | Competent authority of Belgium | 14 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
- Baxter Deutschland GmbHBielefeld, Germany · API manufacture
- Baxter Healthcare CorporationGuayama, United States · API manufacture
- Baxter Healthcare CorporationMarion, United States · API manufacture
- Baxter Healthcare LtdThetford, United Kingdom
- BAXTER PHARMACEUTICALS INDIA PRIVATE LIMITEDAhmedabad, India
- Baxter R and D EuropeBraine l� Alleud, Belgium
- Bieffe Medital SASabinanigo (Senegue), Spain