Suppliers / Catalent Belgium

Catalent Belgium

Belgium 31 employees 2 duplicate records merged Updated 9 July 2026

Catalent Belgium is a finished-dose manufacturer based in Belgium. It appears in 68 regulatory filings across 9 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), ANVISA (Brazil) and DIGEMAPS (DO). Its GMP standing is certified by ZLG (DE) and EMA.

0
active US DMFs
0
valid CEPs
5
registered plants
68
filings across 9 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
0 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Aprilia (LT), United Arab Emirates Not on file
South San Francisco, United Arab Emirates Not on file
Langenfeld (Rheinland), Germany Not on file
Nordrhein-Westfalen, Germany Not on file
Aprilia, Italy Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 25 None
ANVISA (Brazil) 11 None
DIGEMAPS (DO) 8 None
MINSA (CR) 7 None
INVIMA (CO) 5 None
EDE (AE) 4 None
ZLG (DE) None 4
EMA None 2

Questions about Catalent Belgium

Does Catalent Belgium hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Catalent Belgium. It does have 68 filings with 9 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Catalent Belgium manufacture?
5 registered sites are on record, in United Arab Emirates, Germany and Italy (Aprilia (lt), South San Francisco and Langenfeld (rheinland) among others). Every site is listed on this page with the register it came from.
Which regulators recognise Catalent Belgium'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