Suppliers / Laboratorios Rubió

Laboratorios Rubió

Spain 232 employees 2 duplicate records merged Updated 9 July 2026

Laboratorios Rubió is an API and 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 EMA and AEMPS (ES). 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

Atomoxetine finished dose Candesartan finished dose Cholestyramine finished dose Clonazepam finished dose Colesevelam finished dose Erlotinib finished dose Flumazenil finished dose Fluorescein finished dose Ganciclovir finished dose Hydralazine finished dose Hydroxychloroquine finished dose Hydroxyurea finished dose
Show 12 more molecule pages
Methylphenidate API Midodrine finished dose Orlistat finished dose Oxybutynin finished dose Penicillamine finished dose Phenytoin finished dose Prednisone finished dose Primidone finished dose Sevelamer finished dose Sotalol finished dose Teriparatide finished dose Valganciclovir finished dose

Filings and GMP by regulator

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

Questions about Laboratorios Rubió

Does Laboratorios Rubió hold a US DMF or a CEP?
Laboratorios Rubió holds 1 valid CEP. 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.
Is Laboratorios Rubió FDA-registered?
One site operated by Laboratorios Rubió carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Laboratorios Rubió's last inspection go?
The most recent inspection on record closed on 22 September 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Laboratorios Rubió manufacture?
5 registered sites are on record, in United Arab Emirates and Spain (Castellbisbal (barcelona), S.a. Castellbisbal and Barcelona among others). Every site is listed on this page with the register it came from.
What does Laboratorios Rubió make?
1 molecule is on record against Laboratorios Rubió, including Methylphenidate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Laboratorios Rubió's GMP?
Current GMP certificates are on record from EMA and AEMPS (ES). 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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Open risk flags

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

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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