Suppliers / Siegfried

Siegfried

Germany reconciled across 50 public records · 29 entities Updated 9 July 2026

Siegfried is an API manufacturer based in Germany. It holds 94 active US drug master files and 40 valid CEPs. Its filings concentrate with INHRR (VE), INVIMA (CO) and ANMAT (AR). Its GMP standing is certified by EDQM, ANSM (FR) and ZLG (DE), among 14 authorities. Its most recent recorded inspection, by US FDA, closed on 7 November 2025 as VAI.

94
active US DMFs
40
valid CEPs
36
registered plants 12 with an FDA FEI number
588
filings across 15 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 7 November 2025 VAI US FDA
  • 17 September 2025 NAI US FDA
  • 14 February 2025 VAI US FDA
  • 14 August 2024 NAI US FDA
  • 5 July 2024 NAI US FDA
  • 27 September 2023 VAI US FDA
  • 14 September 2023 VAI US FDA
  • 21 April 2023 VAI US FDA
  • 31 March 2023 VAI US FDA
  • 30 March 2023 VAI US FDA
  • 1 February 2023 VAI US FDA
  • 13 January 2023 VAI US FDA

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

Registered plants

Site FDA FEI
Irvine, United Arab Emirates Not on file
Barbera del Valles (Barcelona), United Arab Emirates Not on file
El Masnou (Barcelona), United Arab Emirates Not on file
Zofingen, Switzerland Not on file
Schlieren, Switzerland Not on file
Evionnaz, Switzerland Not on file

30 further sites are on record.

What they file, and where

Molecule Regulators Docs
Buprenorphine EDQM, SFDA (Saudi Arabia), US FDA 8
Tetracaine EDQM, SFDA (Saudi Arabia), US FDA 6
Xylometazoline EDQM, SFDA (Saudi Arabia), US FDA 6
Prilocaine EDQM, SFDA (Saudi Arabia), US FDA 5
Caffeine EDQM, SFDA (Saudi Arabia), US FDA 4
Ephedrine EDQM, SFDA (Saudi Arabia), US FDA 4
Nicotine SFDA (Saudi Arabia), US FDA 4
Pseudoephedrine EDQM, SFDA (Saudi Arabia), US FDA 4
Theophylline EDQM, US FDA 4
Tretinoin EDQM, SFDA (Saudi Arabia), US FDA 4
Show all 40 molecules on file
Articaine EDQM, SFDA (Saudi Arabia), US FDA 3
Bupivacaine EDQM, US FDA 3
Carbamazepine EDQM, US FDA 3
Dextroamphetamine US FDA 3
Fentanyl EDQM, US FDA 3
Naloxone EDQM, US FDA 3
Oxymetazoline EDQM, SFDA (Saudi Arabia), US FDA 3
Phenylephrine EDQM, SFDA (Saudi Arabia), US FDA 3
Amphetamine US FDA 2
Brimonidine EDQM, US FDA 2
Dobutamine EDQM, US FDA 2
Dopamine EDQM, US FDA 2
Isotretinoin EDQM, US FDA 2
Mepivacaine EDQM, US FDA 2
Methylphenidate EDQM, US FDA 2
Naltrexone US FDA 2
Oxybuprocaine EDQM, US FDA 2
Oxybutynin EDQM, US FDA 2
Theophylline-Ethylenediamine EDQM 2
Trospium EDQM, US FDA 2
Acemetacin EDQM 1
Alitretinoin US FDA 1
Amobarbital US FDA 1
Amorolfine Hydrochloride EDQM 1
Amylmetacresol EDQM 1
Ataluren SFDA (Saudi Arabia) 1
Benzatropine US FDA 1
Benzonatate US FDA 1
Bethanechol US FDA 1
Butalbital US FDA 1

Also appears on these molecule pages

Show 1 more molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
INHRR (VE) 152 None
INVIMA (CO) 151 None
ANMAT (AR) 114 None
ARCSA (EC) 93 1
MINSA (CR) 21 None
DIGEMAPS (DO) 19 None
EDQM None 38
ANSM (FR) None 16
ZLG (DE) None 16
ANVISA (Brazil) None 13
EMA None 8
US FDA None 6
MFDS (Korea) None 4
AEMPS (ES) None 2
NAFDAC (NG) None 2
COFEPRIS (MX) None 2
FDA (GH) None 1
MHRA (UK) None 1
EAEU_EEC None 1

Questions about Siegfried

Does Siegfried hold a US DMF or a CEP?
Siegfried holds 94 active US drug master files and 40 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 Siegfried FDA-registered?
12 sites operated by Siegfried 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 Siegfried's last inspection go?
The most recent inspection on record closed on 7 November 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 24 inspections are on file.
Where does Siegfried manufacture?
36 registered sites are on record, in United Arab Emirates, Switzerland, China and Colombia (Irvine, Barbera Del Valles (barcelona) and El Masnou (barcelona) among others). Every site is listed on this page with the register it came from.
What does Siegfried make?
40 molecules are on record against Siegfried, including Buprenorphine, Tetracaine, Xylometazoline and Prilocaine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Siegfried's GMP?
Current GMP certificates are on record from EDQM, ANSM (FR), ZLG (DE), ANVISA (Brazil), EMA and 9 more. 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 7 November 2025.

Sources on this page

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