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

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Open risk flags

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

Sources on this page

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