Suppliers / BIAL - Portela & Ca

BIAL - Portela & Ca

Portugal Updated 9 July 2026

BIAL - Portela & Ca is an API and finished-dose manufacturer based in Portugal. It holds 3 active US drug master files across a filed portfolio of 2 molecules. Its filings concentrate with DIGEMAPS (DO), INFARMED (PT) and AIFA (IT). Its GMP standing is certified by INFARMED (PT) and EMA.

3
active US DMFs
0
valid CEPs
5
registered plants
652
filings across 15 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
S. Mamede do Coronado, United Arab Emirates Not on file
Coronado (São Romão e São Mamede), Portugal Not on file
São Mamede do Coronado, Portugal Not on file
S. Mamede do Coronado, Portugal Not on file
SÃO MAMEDE DO CORONADO, Portugal Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
DIGEMAPS (DO) 360 None
INFARMED (PT) 148 6
AIFA (IT) 65 None
FAMHP (BE) 36 None
MPA (SE) 12 None
MINSA (CR) 8 None
EMA None 1

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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