Suppliers / Orphan Europe

Orphan Europe

France 61 employees Updated 9 July 2026

Orphan Europe is a finished-dose manufacturer based in France. It appears in 10 regulatory filings across 4 regulators, without an active US DMF or CEP on file. Its filings concentrate with Health Canada, DMP (NO) and TGA (Australia).

0
active US DMFs
0
valid CEPs
0
registered plants
10
filings across 4 regulators

Filings and GMP by regulator

Regulator Filings GMP certificates
Health Canada 7 None
DMP (NO) 1 None
TGA (Australia) 1 None
ANSM (FR) 1 None

Limited public record

Beyond the filing counts above, the public registers hold no plant, inspection or portfolio detail for this company as at 9 July 2026. We report that as a gap rather than inferring an answer.

Questions about Orphan Europe

Does Orphan Europe hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Orphan Europe. It does have 10 filings with 4 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Orphan Europe file?
Filings are on record with Health Canada, DMP (NO), TGA (Australia) and ANSM (FR), 10 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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Comparable suppliers

AdhexPharma also in France Advanced Accelerator Applications also in France Aspen Notre Dame De Bondeville also in France Astrazeneca Dunkerque Production also in France Astrea Fontaine also in France

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability