Suppliers / Artivion

Artivion

United States Updated 9 July 2026

Artivion is an API manufacturer based in United States. It holds one valid CEP.

0
active US DMFs
1
valid CEPs
3
registered plants
3
filings across 1 regulators

Registered plants

Site FDA FEI
Kennesaw, United Arab Emirates Not on file
Hechingen - Germany, Portugal Not on file
Kennesaw, United States Not on file

What they file, and where

Molecule Regulators Docs
Bovine Pericardium EDQM 1

Filings and GMP by regulator

Regulator Filings GMP certificates
EDE (AE) 3 None

Questions about Artivion

Does Artivion hold a US DMF or a CEP?
Artivion holds 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 Artivion manufacture?
3 registered sites are on record, in United Arab Emirates, Portugal and United States (Kennesaw and Hechingen - Germany among others). Every site is listed on this page with the register it came from.
What does Artivion make?
1 molecule is on record against Artivion, including Bovine Pericardium. Each links through to that molecule's full manufacturer list.
Where does Artivion file?
Filings are on record with EDE (AE), 3 in total.

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