Suppliers / Laboratorios B Braun

Laboratorios B Braun

Spain Updated 9 July 2026

Laboratorios B Braun is a finished-dose manufacturer based in Spain. It appears in 450 regulatory filings across 12 regulators, without an active US DMF or CEP on file. Its filings concentrate with US FDA, ANVISA (Brazil) and HSA (SG). Its GMP standing is certified by BPOM (ID), HSA (SG) and ANVISA (Brazil). Its most recent recorded inspection, by ANSM (FR), closed on 26 March 2026 as NAI.

0
active US DMFs
0
valid CEPs
5
registered plants
450
filings across 12 regulators

Inspection history

  • 26 March 2026 NAI ANSM (FR)

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
SAO GONCALO, Brazil Not on file
KAB. KARAWANG, Indonesia Not on file
-, Indonesia Not on file
Machakos, Kenya Not on file
HARARE, Zimbabwe Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 152 None
ANVISA (Brazil) 126 1
HSA (SG) 63 2
SFDA (Saudi Arabia) 30 None
PPB (KE) 25 None
BPOM (ID) 14 4

Questions about Laboratorios B Braun

Does Laboratorios B Braun hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Laboratorios B Braun. It does have 450 filings with 12 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
How did Laboratorios B Braun's last inspection go?
The most recent inspection on record closed on 26 March 2026 as NAI (No Action Indicated: nothing objectionable was found). 1 inspection is on file.
Where does Laboratorios B Braun manufacture?
5 registered sites are on record, in Brazil, Indonesia, Kenya and Zimbabwe (SAO Goncalo, Kab. Karawang and - among others). Every site is listed on this page with the register it came from.
Which regulators recognise Laboratorios B Braun's GMP?
Current GMP certificates are on record from BPOM (ID), HSA (SG) 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.

Comparing suppliers?

Choose your molecules and target markets. Laboratorios B Braun comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was NAI, on 26 March 2026.

Comparable suppliers

Alcaliber S A also in Spain Altan Pharmaceuticals also in Spain Berlimed also in Spain Casen Recordati, S.L also in Spain Cyndea Pharma, S.L also in Spain

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates