Suppliers / Siegfried

Siegfried

Switzerland SQG0.F 2 duplicate records merged Updated 9 July 2026

The public registers hold a second record for Siegfried. The fuller profile, with 94 active US DMFs and 40 valid CEPs, is at Siegfried. Figures on this page cover only this record.

Siegfried is an API and finished-dose manufacturer based in Switzerland. It holds 18 active US drug master files and 5 valid CEPs across a filed portfolio of 18 molecules. Its filings concentrate with ANMAT (AR), SAHPRA (ZA) and INVIMA (CO). Its GMP standing is certified by EMA, US FDA and NAFDAC (NG). Its most recent recorded inspection, by US FDA, closed on 14 February 2025 as VAI.

18
active US DMFs
5
valid CEPs
3
registered plants 1 with an FDA FEI number
118
filings across 4 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 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

  • 14 February 2025 VAI US FDA
  • 14 June 2019 NAI US FDA
  • 27 January 2017 VAI US FDA
  • 6 February 2014 NAI US FDA
  • 21 June 2012 VAI US FDA
  • 29 July 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
Zofingen, Switzerland Not on file
Switzerland, Switzerland 3002808158
Barcelona, Nigeria Not on file

What they file, and where

Molecule Regulators Docs
Buprenorphine EDQM, US FDA 6
Nicotine SFDA (Saudi Arabia), US FDA 4
Naltrexone US FDA 3
Acemetacin EDQM 1
Amorolfine Hydrochloride EDQM 1
Ataluren SFDA (Saudi Arabia) 1
Dasatinib SFDA (Saudi Arabia) 1
Fluoxetine US FDA 1
Morphine SFDA (Saudi Arabia) 1
Morphine Hemisulfate 2.5-Hydrate EDQM 1
Show all 18 molecules on file
Naloxone US FDA 1
Nicotine Resinate SFDA (Saudi Arabia) 1
Oxiconazole US FDA 1
Primidone US FDA 1
Proparacaine US FDA 1
Sotalol US FDA 1
Trimethobenzamide US FDA 1
Venlafaxine US FDA 1

Also appears on these molecule pages

Allopurinol finished dose Brexpiprazole finished dose Buprenorphine API Colchicine finished dose Dasatinib API Fluoxetine API Glibenclamide finished dose Glyburide finished dose Hesperidin finished dose Ibandronate finished dose Ibandronic Acid finished dose Morphine API
Show 9 more molecule pages
Naloxone API Naltrexone API Nicotine API Primidone API Prucalopride finished dose Sotalol API Ursodeoxycholic Acid finished dose Venlafaxine API Vortioxetine finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
ANMAT (AR) 114 None
SAHPRA (ZA) 2 None
INVIMA (CO) 1 None
DIGEMAPS (DO) 1 None
EMA None 1
US FDA None 1
NAFDAC (NG) None 1

Questions about Siegfried

Does Siegfried hold a US DMF or a CEP?
Siegfried holds 18 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 Siegfried FDA-registered?
One site operated by Siegfried 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 Siegfried's last inspection go?
The most recent inspection on record closed on 14 February 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Siegfried manufacture?
3 registered sites are on record, in Switzerland and Nigeria (Zofingen, Switzerland and Barcelona). Every site is listed on this page with the register it came from.
What does Siegfried make?
18 molecules are on record against Siegfried, including Buprenorphine, Nicotine, Naltrexone and Acemetacin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Siegfried's GMP?
Current GMP certificates are on record from EMA, US FDA and NAFDAC (NG). 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

  • 4 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 14 February 2025.

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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