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
Darmstadt, Germany Not on file
Germany, Germany 3002911044
Germany, Germany 3002806792
Germany, Germany 3002808332

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

Filings and GMP by regulator

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

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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.

Sources on this page

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