Suppliers / AOP Orphan Pharmaceuticals

AOP Orphan Pharmaceuticals

Austria Updated 9 July 2026

AOP Orphan Pharmaceuticals is a finished-dose manufacturer based in Austria. It appears in 121 regulatory filings across 13 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, MHRA (UK) and AEMPS (ES). Its GMP standing is certified by EMA.

0
active US DMFs
0
valid CEPs
3
registered plants
121
filings across 13 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
Vienna, United Arab Emirates Not on file
Vienna, Austria Not on file
Vialonga, Portugal Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 40 1
MHRA (UK) 29 None
AEMPS (ES) 12 None
URPL (PL) 8 None
MPA (SE) 7 None
AIFA (IT) 5 None

Questions about AOP Orphan Pharmaceuticals

Does AOP Orphan Pharmaceuticals hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for AOP Orphan Pharmaceuticals. It does have 121 filings with 13 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does AOP Orphan Pharmaceuticals manufacture?
3 registered sites are on record, in United Arab Emirates, Austria and Portugal (Vienna and Vialonga among others). Every site is listed on this page with the register it came from.
Which regulators recognise AOP Orphan Pharmaceuticals's GMP?
Current GMP certificates are on record from 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