Suppliers / Siegfried Hameln

Siegfried Hameln

Germany 45 employees Updated 9 July 2026

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

Siegfried Hameln is a finished-dose manufacturer based in Germany. It appears in 14 regulatory filings across 7 regulators, without an active US DMF or CEP on file. Its filings concentrate with MINSA (CR), ARCSA (EC) and UZPHARM (UZ). Its GMP standing is certified by ZLG (DE), ANVISA (Brazil) and EMA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 1 September 2022 as VAI.

0
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
14
filings across 7 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

  • 1 September 2022 VAI US FDA
  • 24 April 2018 VAI US FDA
  • 1 July 2016 VAI US FDA
  • 25 July 2014 VAI US FDA
  • 14 June 2012 OAI US FDA
  • 9 November 2009 VAI US FDA

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

Registered plants

Site FDA FEI
HAMELN, Germany Not on file
Lower Saxony, Germany Not on file
Germany, Germany 3002807877

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 6 None
ARCSA (EC) 2 None
UZPHARM (UZ) 2 None
NAFDAC (NG) 1 None
INVIMA (CO) 1 None
JFDA (JO) 1 None
ZLG (DE) None 8
ANVISA (Brazil) None 8
EMA None 2
MFDS (Korea) None 2
EAEU_EEC None 1

Questions about Siegfried Hameln

Does Siegfried Hameln hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Siegfried Hameln. It does have 14 filings with 7 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Siegfried Hameln FDA-registered?
One site operated by Siegfried Hameln 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 Hameln's last inspection go?
The most recent inspection on record closed on 1 September 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file, of which 1 closed as OAI.
Where does Siegfried Hameln manufacture?
3 registered sites are on record, in Germany (Hameln, Lower Saxony and Germany). Every site is listed on this page with the register it came from.
Which regulators recognise Siegfried Hameln's GMP?
Current GMP certificates are on record from ZLG (DE), ANVISA (Brazil), EMA, MFDS (Korea) and EEC (Eurasian Economic Union). 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 1 September 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