Suppliers / Pharma Waldhof

Pharma Waldhof

Germany Updated 9 July 2026

Pharma Waldhof is a contract manufacturer based in Germany. It holds one active US drug master file and one valid CEP. Its GMP standing is certified by ZLG (DE) and EMA.

1
active US DMFs
1
valid CEPs
3
registered plants
0
filings across 0 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
Duesseldorf, Germany Not on file
Nordrhein-Westfalen, Germany Not on file
Dusseldorf, Germany Not on file

What they file, and where

Molecule Regulators Docs
Adenosine EDQM, US FDA 2

Also appears on these molecule pages

Adenosine contract manufacturing Trifluridine contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
ZLG (DE) None 6
EMA None 1

Questions about Pharma Waldhof

Does Pharma Waldhof hold a US DMF or a CEP?
Pharma Waldhof holds 1 active US drug master file and 1 valid CEP. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Where does Pharma Waldhof manufacture?
3 registered sites are on record, in Germany (Duesseldorf, Nordrhein-westfalen and Dusseldorf). Every site is listed on this page with the register it came from.
What does Pharma Waldhof make?
1 molecule is on record against Pharma Waldhof, including Adenosine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Pharma Waldhof'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