Suppliers / Haupt Pharma Amareg

Haupt Pharma Amareg

Germany Updated 9 July 2026

Haupt Pharma Amareg is a finished-dose manufacturer based in Germany. It appears in 26 regulatory filings across 8 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), NAFDAC (NG) and INVIMA (CO). Its GMP standing is certified by ZLG (DE), EAEU_EEC and ANVISA (Brazil), among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 26 July 2024 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
26
filings across 8 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 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

  • 26 July 2024 VAI US FDA
  • 7 June 2019 VAI US FDA
  • 10 November 2017 VAI US FDA
  • 26 August 2016 VAI US FDA
  • 22 November 2013 NAI US FDA

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

Registered plants

Site FDA FEI
Regensburg, United Arab Emirates Not on file
REGENSBURG, Germany Not on file
Germany, Germany 3008293991
Bavaria, Germany Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 8 None
NAFDAC (NG) 4 None
INVIMA (CO) 4 None
NPRA (MY) 4 None
JFDA (JO) 2 None
EDE (AE) 2 None
ZLG (DE) None 10
EAEU_EEC None 4
ANVISA (Brazil) None 2
EMA None 2
US FDA None 1
NCELS (KZ) None 1

Questions about Haupt Pharma Amareg

Does Haupt Pharma Amareg hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Haupt Pharma Amareg. It does have 26 filings with 8 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Haupt Pharma Amareg FDA-registered?
One site operated by Haupt Pharma Amareg 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 Amareg's last inspection go?
The most recent inspection on record closed on 26 July 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Haupt Pharma Amareg manufacture?
4 registered sites are on record, in United Arab Emirates and Germany (Regensburg, Regensburg and Germany among others). Every site is listed on this page with the register it came from.
Which regulators recognise Haupt Pharma Amareg's GMP?
Current GMP certificates are on record from ZLG (DE), EEC (Eurasian Economic Union), ANVISA (Brazil), EMA, US FDA and 1 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.

Comparing suppliers?

Choose your molecules and target markets. Haupt Pharma Amareg comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was VAI, on 26 July 2024.

Comparable suppliers

AESICA Pharmaceuticals also in Germany Alfred E. Tiefenbacher (GmbH also in Germany Almirall Hermal also in Germany Aqvida also in Germany Aristo Pharma also in Germany

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