Suppliers / B. Braun Melsungen

B. Braun Melsungen

Germany 2 duplicate records merged Updated 9 July 2026

B. Braun Melsungen is a finished-dose manufacturer based in Germany. It appears in 894 regulatory filings across 25 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), EMA and FAMHP (BE). Its GMP standing is certified by ZLG (DE), EMA and ANVISA (Brazil), among 6 authorities.

0
active US DMFs
0
valid CEPs
7
registered plants
894
filings across 25 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
Berlin, United Arab Emirates Not on file
MELSUNGEN, Germany Not on file
Hassia, Germany Not on file
Hessen, Germany Not on file
Berlin, Germany Not on file
Hesse, Germany Not on file

1 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 282 None
EMA 156 13
FAMHP (BE) 135 None
MPA (SE) 82 None
INFARMED (PT) 74 None
DMP (NO) 49 None
ZLG (DE) None 32
ANVISA (Brazil) None 5
MFDS (Korea) None 2
EAEU_EEC None 1
NAFDAC (NG) None 1

Questions about B. Braun Melsungen

Does B. Braun Melsungen hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for B. Braun Melsungen. It does have 894 filings with 25 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does B. Braun Melsungen manufacture?
7 registered sites are on record, in United Arab Emirates, Germany and Saudi Arabia (Berlin, Melsungen and Hassia among others). Every site is listed on this page with the register it came from.
Which regulators recognise B. Braun Melsungen's GMP?
Current GMP certificates are on record from ZLG (DE), EMA, ANVISA (Brazil), MFDS (Korea), EEC (Eurasian Economic Union) and 1 more. 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