Suppliers / Almirall Hermal

Almirall Hermal

Germany 129 employees Updated 9 July 2026

Almirall Hermal is a finished-dose manufacturer based in Germany. It appears in 123 regulatory filings across 11 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, URPL (PL) and AIFA (IT). Its GMP standing is certified by ZLG (DE), EMA and MINPROMTORG (RU). Its most recent recorded inspection, by US FDA, closed on 6 May 2021 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
123
filings across 11 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 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

  • 6 May 2021 VAI US FDA
  • 29 March 2019 VAI US FDA
  • 26 September 2014 NAI US FDA
  • 13 April 2012 VAI US FDA

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

Registered plants

Site FDA FEI
Reinbek, United Arab Emirates Not on file
Schleswig-Holstein, Germany Not on file
Reinbek, Germany Not on file
Germany, Germany 3002807154

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 45 2
URPL (PL) 34 None
AIFA (IT) 17 None
INFARMED (PT) 8 None
EDA (EG) 4 None
NPRA (MY) 3 None
ZLG (DE) None 12
MINPROMTORG (RU) None 1

Questions about Almirall Hermal

Does Almirall Hermal hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Almirall Hermal. It does have 123 filings with 11 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Almirall Hermal FDA-registered?
One site operated by Almirall Hermal 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 Almirall Hermal's last inspection go?
The most recent inspection on record closed on 6 May 2021 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Almirall Hermal manufacture?
4 registered sites are on record, in United Arab Emirates and Germany (Reinbek, Schleswig-holstein and Germany among others). Every site is listed on this page with the register it came from.
Which regulators recognise Almirall Hermal's GMP?
Current GMP certificates are on record from ZLG (DE), EMA and MINPROMTORG (RU). 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 May 2021.

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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