Suppliers / Merz Pharma Gmbh & Co. Kgaa

Merz Pharma Gmbh & Co. Kgaa

Germany Updated 9 July 2026

Merz Pharma Gmbh & Co. Kgaa is a finished-dose manufacturer based in Germany. It appears in 79 regulatory filings across 9 regulators, without an active US DMF or CEP on file. Its filings concentrate with SWISSMEDIC (CH), MHRA (UK) and MINSA (CR). Its GMP standing is certified by ZLG (DE), ANVISA (Brazil) and EMA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 6 November 2024 as VAI.

0
active US DMFs
0
valid CEPs
11
registered plants 2 with an FDA FEI number
79
filings across 9 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 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 November 2024 VAI US FDA
  • 29 June 2022 VAI US FDA
  • 23 August 2019 VAI US FDA
  • 4 July 2017 NAI US FDA
  • 29 April 2016 NAI US FDA
  • 15 September 2015 NAI US FDA
  • 25 September 2013 NAI US FDA
  • 28 October 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
Reinheim, United Arab Emirates Not on file
Reinheim, United Arab Emirates Not on file
Allschwil, Switzerland Not on file
REINHEIM, Germany Not on file
Germany, Germany 3006896175
Sachsen-Anhalt, Germany Not on file

5 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
SWISSMEDIC (CH) 43 None
MHRA (UK) 7 None
MINSA (CR) 6 None
DIGEMAPS (DO) 6 None
UZPHARM (UZ) 5 None
ARCSA (EC) 4 None
ZLG (DE) None 10
ANVISA (Brazil) None 3
EMA None 2
MFDS (Korea) None 2
US FDA None 1

Questions about Merz Pharma Gmbh & Co. Kgaa

Does Merz Pharma Gmbh & Co. Kgaa hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Merz Pharma Gmbh & Co. Kgaa. It does have 79 filings with 9 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Merz Pharma Gmbh & Co. Kgaa FDA-registered?
2 sites operated by Merz Pharma Gmbh & Co. Kgaa carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Merz Pharma Gmbh & Co. Kgaa's last inspection go?
The most recent inspection on record closed on 6 November 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Merz Pharma Gmbh & Co. Kgaa manufacture?
11 registered sites are on record, in United Arab Emirates, Switzerland, Germany and Portugal (Reinheim, Allschwil and Reinheim among others). Every site is listed on this page with the register it came from.
Which regulators recognise Merz Pharma Gmbh & Co. Kgaa's GMP?
Current GMP certificates are on record from ZLG (DE), ANVISA (Brazil), EMA, MFDS (Korea) and US FDA. 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 November 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