Suppliers / Baxter Healthcare

Baxter Healthcare

United States 8 duplicate records merged Updated 9 July 2026

Baxter Healthcare is a finished-dose manufacturer based in United States. It holds 3 active US drug master files across a filed portfolio of 3 molecules. Its filings concentrate with MEDSAFE (NZ), US FDA and MHRA (UK). Its GMP standing is certified by MHRA (UK), ANVISA (Brazil) and US FDA, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 29 September 2025 as OAI.

3
active US DMFs
0
valid CEPs
12
registered plants 1 with an FDA FEI number
1,053
filings across 24 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
0 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 29 September 2025 OAI US FDA
  • 26 March 2025 VAI US FDA
  • 1 August 2024 OAI US FDA
  • 19 July 2024 VAI US FDA
  • 9 February 2024 OAI US FDA
  • 29 November 2023 VAI US FDA
  • 15 November 2023 NAI US FDA
  • 31 October 2023 OAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Hayward CA 94545, United Arab Emirates Not on file
THETFORD, United Kingdom Not on file
OXFORD, United Kingdom Not on file
CROYDON, United Kingdom Not on file
NORTHAMPTON, United Kingdom Not on file
READING, United Kingdom Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Cyclophosphamide US FDA 1
Ifosfamide US FDA 1
Mesna US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
MEDSAFE (NZ) 351 None
US FDA 323 3
MHRA (UK) 114 16
DH (HK) 53 None
HSA (SG) 44 3
DAV (Vietnam) 25 None
ANVISA (Brazil) None 4

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Open risk flags

  • 81 active litigation matters are on record.
  • One recent serious compliance event is on record.
  • The most recent inspection outcome was OAI, on 29 September 2025.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates