Is Bial Portela & Ca, S.A. FDA approved?

Bial Portela & Ca, S.A. holds 1 FDA-registered establishment in Portugal. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Bial Portela & Ca, S.A.'s drugs manufactured?

The FDA register lists Sao Mamede Coronado. Registered operations: analytical testing, finished drug manufacture, packaging.

Bial Portela & Ca, S.A.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 0
Live patents: 0
Countries: 1
Base: Portugal

Authorisation

Registered operations

Analytical testing1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Bial Portela & Ca., S.A.Registrant: Bial Portela & Ca, S.A.	Avenida Da Siderurgia Nacional, Sao Mamede Coronado, 4745-457, Portugal (PRT)	Analytical testing, Finished drug manufacture, Packaging	3007703969449155415

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Common questions

Is Bial Portela & Ca, S.A. FDA approved?: Bial Portela & Ca, S.A. holds 1 FDA-registered establishment in Portugal. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Bial Portela & Ca, S.A.'s drugs manufactured?: The FDA register lists Sao Mamede Coronado. Registered operations: analytical testing, finished drug manufacture, packaging.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.