Suppliers / Haupt Pharma Wuelfing

Haupt Pharma Wuelfing

Germany Updated 9 July 2026

Haupt Pharma Wuelfing is a finished-dose manufacturer based in Germany. It appears in 38 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by ZLG (DE) and US FDA. Its most recent recorded inspection, by US FDA, closed on 6 June 2023 as VAI.

0
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
38
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 6 June 2023 VAI US FDA
  • 7 December 2018 NAI US FDA
  • 17 March 2017 NAI US FDA
  • 28 March 2014 VAI US FDA
  • 20 April 2012 VAI US FDA
  • 6 November 2008 VAI US FDA

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

Registered plants

Site FDA FEI
Germany, Germany 3003183252
Gronau/Leine, Germany Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
NPRA (MY) 38 None
ZLG (DE) None 2
US FDA None 1

Questions about Haupt Pharma Wuelfing

Does Haupt Pharma Wuelfing hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Haupt Pharma Wuelfing. It does have 38 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Haupt Pharma Wuelfing FDA-registered?
One site operated by Haupt Pharma Wuelfing 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 Haupt Pharma Wuelfing's last inspection go?
The most recent inspection on record closed on 6 June 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Haupt Pharma Wuelfing manufacture?
2 registered sites are on record, in Germany (Germany and Gronau/leine). Every site is listed on this page with the register it came from.
Which regulators recognise Haupt Pharma Wuelfing'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

  • The most recent inspection outcome was VAI, on 6 June 2023.

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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