Suppliers / Ursapharm Arzneimittel

Ursapharm Arzneimittel

Germany 337 employees Updated 9 July 2026

Ursapharm Arzneimittel is a finished-dose manufacturer based in Germany. It appears in 61 regulatory filings across 7 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, EDE (AE) and NPRA (MY). Its GMP standing is certified by ZLG (DE), US FDA and EMA, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 31 October 2024 as VAI.

0
active US DMFs
0
valid CEPs
5
registered plants 1 with an FDA FEI number
61
filings across 7 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

  • 31 October 2024 VAI US FDA
  • 25 September 2015 NAI US FDA
  • 13 September 2013 VAI US FDA

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

Registered plants

Site FDA FEI
Sarrbrucken, United Arab Emirates Not on file
SAARBRÜCKEN, Germany Not on file
Germany, Germany 3004978466
Saarbruecken, Germany Not on file
Saarland, Germany Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 31 1
EDE (AE) 12 None
NPRA (MY) 8 None
ARCSA (EC) 6 None
UZPHARM (UZ) 2 None
SFDA (Saudi Arabia) 1 None
ZLG (DE) None 6
US FDA None 1
ANVISA (Brazil) None 1

Questions about Ursapharm Arzneimittel

Does Ursapharm Arzneimittel hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Ursapharm Arzneimittel. It does have 61 filings with 7 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Ursapharm Arzneimittel FDA-registered?
One site operated by Ursapharm Arzneimittel 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 Ursapharm Arzneimittel's last inspection go?
The most recent inspection on record closed on 31 October 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Ursapharm Arzneimittel manufacture?
5 registered sites are on record, in United Arab Emirates and Germany (Sarrbrucken, Saarbrücken and Germany among others). Every site is listed on this page with the register it came from.
Which regulators recognise Ursapharm Arzneimittel's GMP?
Current GMP certificates are on record from ZLG (DE), US FDA, EMA and ANVISA (Brazil). 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 31 October 2024.

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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