Suppliers / Hevert Arzneimittel GmbH

Hevert Arzneimittel GmbH

Germany Updated 9 July 2026

Hevert Arzneimittel GmbH is a finished-dose manufacturer based in Germany. It appears in 94 regulatory filings across 4 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, EDE (AE) and DMP (NO). Its GMP standing is certified by ZLG (DE) and EMA. Its most recent recorded inspection, by US FDA, closed on 6 December 2022 as VAI.

0
active US DMFs
0
valid CEPs
6
registered plants 1 with an FDA FEI number
94
filings across 4 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 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 December 2022 VAI US FDA
  • 12 March 2020 VAI US FDA
  • 29 September 2017 VAI US FDA

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

Registered plants

Site FDA FEI
Nussbaum, United Arab Emirates Not on file
Germany, Germany 3010165877
Bad Sobernheim, Germany Not on file
Nussbaum, Germany Not on file
Rheinland-Pfalz, Germany Not on file
Bad Sobernheim, Germany Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 87 2
EDE (AE) 3 None
DMP (NO) 3 None
INVIMA (CO) 1 None
ZLG (DE) None 8

Questions about Hevert Arzneimittel GmbH

Does Hevert Arzneimittel GmbH hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Hevert Arzneimittel GmbH. It does have 94 filings with 4 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Hevert Arzneimittel GmbH FDA-registered?
One site operated by Hevert Arzneimittel GmbH 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 Hevert Arzneimittel GmbH's last inspection go?
The most recent inspection on record closed on 6 December 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Hevert Arzneimittel GmbH manufacture?
6 registered sites are on record, in United Arab Emirates and Germany (Nussbaum, Germany and Bad Sobernheim among others). Every site is listed on this page with the register it came from.
Which regulators recognise Hevert Arzneimittel GmbH's GMP?
Current GMP certificates are on record from ZLG (DE) and EMA. 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 December 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