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

What they file, and where

Molecule Regulators Docs
Opicapone US FDA 2
Eslicarbazepine Acetate US FDA 1

Also appears on these molecule pages

Dipyridamole finished dose Eslicarbazepine API Nortriptyline finished dose Phenobarbital finished dose Praziquantel finished dose Pyrantel finished dose Rupatadine finished dose

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

Questions about BIAL - Portela & Ca

Does BIAL - Portela & Ca hold a US DMF or a CEP?
BIAL - Portela & Ca holds 3 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Where does BIAL - Portela & Ca manufacture?
5 registered sites are on record, in United Arab Emirates and Portugal (S. Mamede Do Coronado, Coronado (são Romão E São Mamede) and São Mamede Do Coronado among others). Every site is listed on this page with the register it came from.
What does BIAL - Portela & Ca make?
2 molecules are on record against BIAL - Portela & Ca, including Opicapone and Eslicarbazepine Acetate. Each links through to that molecule's full manufacturer list.
Which regulators recognise BIAL - Portela & Ca's GMP?
Current GMP certificates are on record from INFARMED (PT) and EMA. 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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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