Suppliers / Ge Healthcare Buchler Gmbh

Ge Healthcare Buchler Gmbh

Germany Updated 9 July 2026

The public registers hold a second record for Ge Healthcare Buchler Gmbh. The fuller profile, with 13 active US DMFs and 4 valid CEPs, is at GE Healthcare. Figures on this page cover only this record.

Ge Healthcare Buchler Gmbh is a finished-dose manufacturer based in Germany. It holds 3 active US drug master files and one valid CEP across a filed portfolio of 2 molecules. Its filings concentrate with EMA, INFARMED (PT) and MPA (SE). Its GMP standing is certified by ZLG (DE) and EMA. Its most recent recorded inspection, by US FDA, closed on 15 August 2019 as VAI.

3
active US DMFs
1
valid CEPs
6
registered plants 1 with an FDA FEI number
38
filings across 4 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 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

  • 15 August 2019 VAI US FDA
  • 16 February 2017 VAI US FDA
  • 19 March 2014 NAI US FDA
  • 22 September 2010 VAI US FDA

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

Registered plants

Site FDA FEI
Germany, Germany 3002806608
Brunswick, Germany Not on file
Braunschweig, Germany Not on file
Lower Saxony, Germany Not on file
Brunswick, Germany Not on file
Braunschweig, Germany Not on file

What they file, and where

Molecule Regulators Docs
Quinidine EDQM, US FDA 3
Quinine US FDA 1

Also appears on these molecule pages

Gadobutrol finished dose Gadoteric Acid finished dose Iodixanol finished dose Iohexol finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 23 1
INFARMED (PT) 7 None
MPA (SE) 7 None
URPL (PL) 1 None
ZLG (DE) None 12

Questions about Ge Healthcare Buchler Gmbh

Does Ge Healthcare Buchler Gmbh hold a US DMF or a CEP?
Ge Healthcare Buchler Gmbh holds 3 active US drug master files and 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 Ge Healthcare Buchler Gmbh FDA-registered?
One site operated by Ge Healthcare Buchler Gmbh 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 Ge Healthcare Buchler Gmbh's last inspection go?
The most recent inspection on record closed on 15 August 2019 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Ge Healthcare Buchler Gmbh manufacture?
6 registered sites are on record, in Germany (Germany, Brunswick and Braunschweig among others). Every site is listed on this page with the register it came from.
What does Ge Healthcare Buchler Gmbh make?
2 molecules are on record against Ge Healthcare Buchler Gmbh, including Quinidine and Quinine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Ge Healthcare Buchler Gmbh's GMP?
Current GMP certificates are on record from ZLG (DE) and EMA. 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 15 August 2019.

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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