Suppliers / Heraeus Precious Metals GmbH

Heraeus Precious Metals GmbH

Germany 3 employees Updated 9 July 2026

Heraeus Precious Metals GmbH is an API manufacturer based in Germany. It holds 8 active US drug master files across a filed portfolio of 7 molecules. Its GMP standing is certified by ZLG (DE). Its most recent recorded inspection, by US FDA, closed on 5 August 2022 as VAI.

8
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 5 August 2022 VAI US FDA
  • 18 May 2018 VAI US FDA
  • 7 March 2014 NAI US FDA
  • 4 March 2010 NAI 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 3002808476
Hanau, Germany Not on file

What they file, and where

Molecule Regulators Docs
Oxaliplatin SFDA (Saudi Arabia), US FDA 3
Aminolevulinic Acid US FDA 1
Bendamustine US FDA 1
Carboplatin US FDA 1
Cisplatin US FDA 1
Dacarbazine US FDA 1
Thiotepa US FDA 1

Also appears on these molecule pages

Bendamustine contract manufacturing Carboplatin contract manufacturing Cisplatin contract manufacturing Dacarbazine API Oxaliplatin contract manufacturing Thiotepa contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
ZLG (DE) None 4

Questions about Heraeus Precious Metals GmbH

Does Heraeus Precious Metals GmbH hold a US DMF or a CEP?
Heraeus Precious Metals GmbH holds 8 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 Heraeus Precious Metals GmbH FDA-registered?
One site operated by Heraeus Precious Metals 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 Heraeus Precious Metals GmbH's last inspection go?
The most recent inspection on record closed on 5 August 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Heraeus Precious Metals GmbH manufacture?
2 registered sites are on record, in Germany (Germany and Hanau). Every site is listed on this page with the register it came from.
What does Heraeus Precious Metals GmbH make?
7 molecules are on record against Heraeus Precious Metals GmbH, including Oxaliplatin, Aminolevulinic Acid, Bendamustine and Carboplatin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Heraeus Precious Metals GmbH's GMP?
Current GMP certificates are on record from ZLG (DE). 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 5 August 2022.

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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