Suppliers / Laboratorios Rubió

Laboratorios Rubió

Spain 232 employees 2 duplicate records merged Updated 9 July 2026

Laboratorios Rubió is a finished-dose manufacturer based in Spain. It holds one valid CEP. Its filings concentrate with AEMPS (ES), EMA and INFARMED (PT). Its GMP standing is certified by AEMPS (ES) and EMA. Its most recent recorded inspection, by US FDA, closed on 22 September 2022 as VAI.

0
active US DMFs
1
valid CEPs
5
registered plants 1 with an FDA FEI number
219
filings across 7 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 22 September 2022 VAI US FDA
  • 31 October 2019 VAI US FDA
  • 18 June 2019 VAI US FDA
  • 30 June 2017 NAI US FDA

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

Registered plants

Site FDA FEI
Castellbisbal (Barcelona), United Arab Emirates Not on file
S.A. Castellbisbal, Spain Not on file
Barcelona, Spain Not on file
Castellbisbal, Spain Not on file
Spain, Spain 3010164079

What they file, and where

Molecule Regulators Docs
Methylphenidate EDQM 1

Also appears on these molecule pages

Alendronic Acid finished dose Calcitriol finished dose Candesartan finished dose Capecitabine finished dose Clonazepam finished dose Hydralazine finished dose Ibandronic Acid finished dose Oxybutynin finished dose Phenytoin finished dose Prednisone finished dose Sotalol finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
AEMPS (ES) 172 1
EMA 27 1
INFARMED (PT) 13 None
SFDA (Saudi Arabia) 2 None
DIGEMAPS (DO) 2 None
MINSA (CR) 2 None

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Open risk flags

  • The most recent inspection outcome was VAI, on 22 September 2022.

Sources on this page

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