Suppliers / Besins Manufacturing Belgium

Besins Manufacturing Belgium

Belgium 21 employees Updated 9 July 2026

Besins Manufacturing Belgium is a finished-dose manufacturer based in Belgium. It appears in 10 regulatory filings across 6 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), INVIMA (CO) and NCELS (KZ). Its GMP standing is certified by EMA and ANVISA (Brazil).

0
active US DMFs
0
valid CEPs
3
registered plants
10
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
DRONGENBOS, Belgium Not on file
Drogenbos, Belgium Not on file
Muel, Spain Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 3 None
INVIMA (CO) 3 None
NCELS (KZ) 1 None
UZPHARM (UZ) 1 None
NPRA (MY) 1 None
MINSA (CR) 1 None
EMA None 5
ANVISA (Brazil) None 2

Questions about Besins Manufacturing Belgium

Does Besins Manufacturing Belgium hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Besins Manufacturing Belgium. It does have 10 filings with 6 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Besins Manufacturing Belgium manufacture?
3 registered sites are on record, in Belgium and Spain (Drongenbos, Drogenbos and Muel). Every site is listed on this page with the register it came from.
Which regulators recognise Besins Manufacturing Belgium's GMP?
Current GMP certificates are on record from EMA and ANVISA (Brazil). 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