Suppliers / Merz Pharmaceuticals

Merz Pharmaceuticals

Germany Updated 9 July 2026

Merz Pharmaceuticals is a finished-dose manufacturer based in Germany. It appears in 214 regulatory filings across 14 regulators, without an active US DMF or CEP on file. Its filings concentrate with FAMHP (BE), AIFA (IT) and EMA. Its GMP standing is certified by ZLG (DE) and EMA.

0
active US DMFs
0
valid CEPs
2
registered plants
214
filings across 14 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Frankfurt, Germany Not on file
Frankfurt am Main, Germany Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
FAMHP (BE) 64 None
AIFA (IT) 52 None
EMA 34 1
Health Canada 17 None
MPA (SE) 13 None
INFARMED (PT) 13 None
ZLG (DE) None 4

Questions about Merz Pharmaceuticals

Does Merz Pharmaceuticals hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Merz Pharmaceuticals. It does have 214 filings with 14 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Merz Pharmaceuticals manufacture?
2 registered sites are on record, in Germany (Frankfurt and Frankfurt Am Main). Every site is listed on this page with the register it came from.
Which regulators recognise Merz Pharmaceuticals'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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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates