Suppliers / Solupharm Pharmazeutische Erzeugnisse

Solupharm Pharmazeutische Erzeugnisse

Germany 110 employees Updated 9 July 2026

Solupharm Pharmazeutische Erzeugnisse is a finished-dose manufacturer based in Germany. It appears in 92 regulatory filings across 15 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, DIGEMAPS (DO) and EDE (AE). Its GMP standing is certified by ZLG (DE), EMA and EAEU_EEC, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 29 July 2022 as VAI.

0
active US DMFs
0
valid CEPs
8
registered plants 1 with an FDA FEI number
92
filings across 15 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

  • 29 July 2022 VAI US FDA
  • 2 February 2018 VAI US FDA
  • 21 June 2016 VAI US FDA
  • 22 September 2014 VAI US FDA
  • 22 November 2011 NAI US FDA

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

Registered plants

Site FDA FEI
Ismaning, United Arab Emirates Not on file
Melsungen, United Arab Emirates Not on file
34212 Melsungen, United Arab Emirates Not on file
Ismaning, Germany Not on file
Bavaria, Germany Not on file
MELSUNGEN, Germany Not on file

2 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 30 3
DIGEMAPS (DO) 17 None
EDE (AE) 10 None
ARCSA (EC) 5 None
NPRA (MY) 5 None
MINSA (CR) 5 None
ZLG (DE) None 18
EAEU_EEC None 3
ANVISA (Brazil) None 2

Questions about Solupharm Pharmazeutische Erzeugnisse

Does Solupharm Pharmazeutische Erzeugnisse hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Solupharm Pharmazeutische Erzeugnisse. It does have 92 filings with 15 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Solupharm Pharmazeutische Erzeugnisse FDA-registered?
One site operated by Solupharm Pharmazeutische Erzeugnisse 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 Solupharm Pharmazeutische Erzeugnisse's last inspection go?
The most recent inspection on record closed on 29 July 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Solupharm Pharmazeutische Erzeugnisse manufacture?
8 registered sites are on record, in United Arab Emirates and Germany (Ismaning, Melsungen and 34212 Melsungen among others). Every site is listed on this page with the register it came from.
Which regulators recognise Solupharm Pharmazeutische Erzeugnisse's GMP?
Current GMP certificates are on record from ZLG (DE), EMA, EEC (Eurasian Economic Union) 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 29 July 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