Suppliers / Evonik Operations

Evonik Operations

Germany 1EVK.MI Updated 9 July 2026

Evonik Operations is an API manufacturer based in Germany. It holds 3 active US drug master files and 5 valid CEPs across a filed portfolio of 5 molecules. Its GMP standing is certified by ZLG (DE) and US FDA. Its most recent recorded inspection, by US FDA, closed on 24 October 2024 as VAI.

3
active US DMFs
5
valid CEPs
10
registered plants 4 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
4 of 4 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 24 October 2024 VAI US FDA
  • 27 June 2024 VAI US FDA
  • 15 September 2023 NAI US FDA
  • 29 October 2020 VAI US FDA
  • 18 February 2020 NAI US FDA
  • 13 September 2019 NAI US FDA
  • 29 September 2017 VAI US FDA
  • 22 September 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
Essen, Germany Not on file
Dossenheim, Germany Not on file
Dossenheim, Germany Not on file
Germany, Germany 3002808332
Darmstadt, Germany Not on file
Hanau, Germany Not on file

4 further sites are on record.

What they file, and where

Molecule Regulators Docs
Azelastine EDQM, US FDA 2
Lisinopril EDQM, US FDA 2
Lorazepam EDQM, US FDA 2
Dimercaprol EDQM 1
Hydrogen Peroxide Solution (30 Per Cent) EDQM 1

Also appears on these molecule pages

Azelastine API Lisinopril API Lorazepam API

Filings and GMP by regulator

Regulator Filings GMP certificates
ZLG (DE) None 34
US FDA None 3

Questions about Evonik Operations

Does Evonik Operations hold a US DMF or a CEP?
Evonik Operations holds 3 active US drug master files and 5 valid CEPs. 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 Evonik Operations FDA-registered?
4 sites operated by Evonik Operations 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 Evonik Operations's last inspection go?
The most recent inspection on record closed on 24 October 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Evonik Operations manufacture?
10 registered sites are on record, in Germany (Essen, Dossenheim and Germany among others). Every site is listed on this page with the register it came from.
What does Evonik Operations make?
5 molecules are on record against Evonik Operations, including Azelastine, Lisinopril, Lorazepam and Dimercaprol. Each links through to that molecule's full manufacturer list.
Which regulators recognise Evonik Operations's GMP?
Current GMP certificates are on record from ZLG (DE) 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.

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Open risk flags

  • 5 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 24 October 2024.

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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