Suppliers / Galenica AB

Galenica AB

Sweden 60 employees Updated 9 July 2026

Galenica AB is a finished-dose manufacturer based in Sweden. It appears in 16 regulatory filings across 6 regulators, without an active US DMF or CEP on file. Its filings concentrate with DKMA (DK), EMA and MPA (SE). Its GMP standing is certified by EMA.

0
active US DMFs
0
valid CEPs
3
registered plants
16
filings across 6 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
Kryoneri, United Arab Emirates Not on file
CASABLANCA, Morocco Not on file
Malmo, Sweden Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
DKMA (DK) 5 None
EMA 4 2
MPA (SE) 3 None
DMP (NO) 2 None
EDE (AE) 1 None
INFARMED (PT) 1 None

Questions about Galenica AB

Does Galenica AB hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Galenica AB. It does have 16 filings with 6 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Galenica AB manufacture?
3 registered sites are on record, in United Arab Emirates, Morocco and Sweden (Kryoneri, Casablanca and Malmo). Every site is listed on this page with the register it came from.
Which regulators recognise Galenica AB'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