Suppliers / Baxter Oncology

Baxter Oncology

Germany 2 duplicate records merged Updated 9 July 2026

Baxter Oncology is an API and finished-dose manufacturer based in Germany. It holds one active US drug master file. Its filings concentrate with EDE (AE), ARCSA (EC) and INVIMA (CO). Its GMP standing is certified by ZLG (DE), NCELS (KZ) and MFDS (Korea).

1
active US DMFs
0
valid CEPs
2
registered plants
531
filings across 11 regulators

Registered plants

Site FDA FEI
Halle/Westfalen, United Arab Emirates Not on file
Halle (Westf), Germany Not on file

What they file, and where

Molecule Regulators Docs
Cyclophosphamide US FDA 1

Also appears on these molecule pages

Cyclophosphamide API Cytarabine finished dose Ifosfamide finished dose Mesna finished dose Temozolomide finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
EDE (AE) 481 None
ARCSA (EC) 16 None
INVIMA (CO) 10 None
DPM (TN) 7 None
EDA (EG) 7 None
ANPP (DZ) 3 None
ZLG (DE) None 4
NCELS (KZ) None 2
MFDS (Korea) None 2

Questions about Baxter Oncology

Does Baxter Oncology hold a US DMF or a CEP?
Baxter Oncology holds 1 active US drug master file. 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.
Where does Baxter Oncology manufacture?
2 registered sites are on record, in United Arab Emirates and Germany (Halle/westfalen and Halle (westf)). Every site is listed on this page with the register it came from.
What does Baxter Oncology make?
1 molecule is on record against Baxter Oncology, including Cyclophosphamide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Baxter Oncology's GMP?
Current GMP certificates are on record from ZLG (DE), NCELS (KZ) and MFDS (Korea). 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.

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Sources on this page

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