Suppliers / CSL Behring

CSL Behring

United States 2 duplicate records merged Updated 9 July 2026

CSL BEHRING is a finished-dose manufacturer based in United States. It holds one valid CEP. Its filings concentrate with EMA, Health Canada and AIFA (IT). Its GMP standing is certified by ZLG (DE), EMA and ANVISA (Brazil), among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 2 March 2023 as VAI.

0
active US DMFs
1
valid CEPs
12
registered plants 2 with an FDA FEI number
1,052
filings across 32 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
4 of 8 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 2 March 2023 VAI US FDA
  • 4 March 2022 VAI US FDA
  • 24 September 2021 VAI US FDA
  • 18 February 2020 VAI US FDA
  • 23 May 2019 VAI US FDA
  • 18 October 2018 VAI US FDA
  • 13 April 2018 VAI US FDA
  • 19 July 2017 VAI US FDA

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

Registered plants

Site FDA FEI
Bern, United Arab Emirates Not on file
Bern, United Arab Emirates Not on file
35041 Marburg, United Arab Emirates Not on file
BERN (BERNA), Switzerland Not on file
Switzerland, Switzerland 3002806716
Bern, Switzerland Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Water For Injections EDQM 1

Also appears on these molecule pages

Carvedilol finished dose Lenacapavir finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 136 6
Health Canada 115 None
AIFA (IT) 115 None
FAMHP (BE) 87 None
INFARMED (PT) 63 None
MEDSAFE (NZ) 61 None
ZLG (DE) None 8
ANVISA (Brazil) None 4
HSA (SG) None 1
EAEU_EEC None 1

Questions about CSL Behring

Does CSL Behring hold a US DMF or a CEP?
CSL Behring holds 1 valid CEP. 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 CSL Behring FDA-registered?
2 sites operated by CSL Behring carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did CSL Behring's last inspection go?
The most recent inspection on record closed on 2 March 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does CSL Behring manufacture?
12 registered sites are on record, in United Arab Emirates, Switzerland, Germany and Denmark (Bern, 35041 Marburg and Bern (berna) among others). Every site is listed on this page with the register it came from.
What does CSL Behring make?
1 molecule is on record against CSL Behring, including Water For Injections. Each links through to that molecule's full manufacturer list.
Which regulators recognise CSL Behring's GMP?
Current GMP certificates are on record from ZLG (DE), EMA, ANVISA (Brazil), HSA (SG) and EEC (Eurasian Economic Union). 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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Open risk flags

  • The most recent inspection outcome was VAI, on 2 March 2023.

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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