Suppliers / Baxter Healthcare

Baxter Healthcare

United States 8 duplicate records merged Updated 9 July 2026

Baxter Healthcare is an API and 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 HSA (SG), 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
READING, United Kingdom Not on file
LIVERPOOL, United Kingdom Not on file
NORTHAMPTON, United Kingdom Not on file
CROYDON, United Kingdom Not on file
THETFORD, 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

Arginine finished dose Bendamustine finished dose Benzylpenicillin finished dose Cyclophosphamide API Dalbavancin finished dose Eptifibatide finished dose Eribulin finished dose Esmolol finished dose Foscarnet finished dose Ifosfamide API Isoflurane finished dose Ketamine finished dose
Show 10 more molecule pages
Mesna API Micafungin finished dose Milrinone finished dose Nicardipine finished dose Oxacillin finished dose Regadenoson finished dose Ropivacaine finished dose Scopolamine finished dose Sevoflurane finished dose Threonine finished dose

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

Questions about Baxter Healthcare

Does Baxter Healthcare hold a US DMF or a CEP?
Baxter Healthcare holds 3 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Baxter Healthcare FDA-registered?
One site operated by Baxter Healthcare carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Baxter Healthcare's last inspection go?
The most recent inspection on record closed on 29 September 2025 as OAI (Official Action Indicated, the worst classification: objectionable conditions were found and regulatory action was warranted). 8 inspections are on file, of which 4 closed as OAI.
Where does Baxter Healthcare manufacture?
12 registered sites are on record, in United Arab Emirates, United Kingdom, Puerto Rico and United States (Hayward CA 94545, Reading and Liverpool among others). Every site is listed on this page with the register it came from.
What does Baxter Healthcare make?
3 molecules are on record against Baxter Healthcare, including Cyclophosphamide, Ifosfamide and Mesna. Each links through to that molecule's full manufacturer list.
Which regulators recognise Baxter Healthcare's GMP?
Current GMP certificates are on record from MHRA (UK), ANVISA (Brazil), HSA (SG) and US FDA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

Comparing suppliers?

Choose your molecules and target markets. Baxter Healthcare comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

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

Comparable suppliers

Aarti Pharmalabs shares 3 molecules Jiangsu Hengrui shares 2 molecules MSN Laboratories shares 1 molecule Hetero shares 1 molecule Solara Active Pharma Sciences shares 1 molecule

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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