Suppliers / Tutogen Medical

Tutogen Medical

Germany Updated 9 July 2026

Tutogen Medical is an API manufacturer based in Germany. It holds 2 valid CEPs across a filed portfolio of 2 molecules. Its GMP standing is certified by ZLG (DE) and EMA.

0
active US DMFs
2
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
Neunkirchen am Brand, Germany Not on file
Bavaria, Germany Not on file
Neunkirchen A. Brand, Germany Not on file

What they file, and where

Molecule Regulators Docs
Bovine Pericardium EDQM 1
Processed Bovine Bone EDQM 1

Filings and GMP by regulator

Regulator Filings GMP certificates
ZLG (DE) None 4
EMA None 1

Questions about Tutogen Medical

Does Tutogen Medical hold a US DMF or a CEP?
Tutogen Medical holds 2 valid CEPs. 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 Tutogen Medical manufacture?
3 registered sites are on record, in Germany (Neunkirchen Am Brand, Bavaria and Neunkirchen A. Brand). Every site is listed on this page with the register it came from.
What does Tutogen Medical make?
2 molecules are on record against Tutogen Medical, including Bovine Pericardium and Processed Bovine Bone. Each links through to that molecule's full manufacturer list.
Which regulators recognise Tutogen Medical'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