Suppliers / Laboratorio Reig Jofre

Laboratorio Reig Jofre

Spain Updated 9 July 2026

Laboratorio Reig Jofre is a finished-dose manufacturer based in Spain. It appears in 391 regulatory filings across 14 regulators, without an active US DMF or CEP on file. Its filings concentrate with AEMPS (ES), EMA and AIFA (IT). Its GMP standing is certified by AEMPS (ES), ANVISA (Brazil) and EAEU_EEC, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 23 June 2023 as OAI.

0
active US DMFs
0
valid CEPs
8
registered plants 2 with an FDA FEI number
391
filings across 14 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 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

  • 23 June 2023 OAI US FDA
  • 24 July 2015 OAI US FDA
  • 14 July 2015 OAI US FDA
  • 31 July 2013 VAI US FDA

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

Registered plants

Site FDA FEI
Barcelona, United Arab Emirates Not on file
Barcelona, United Arab Emirates Not on file
BARCELONA, Spain Not on file
Toledo, Spain Not on file
Barcelona, Spain Not on file
Toledo, Spain Not on file

2 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
AEMPS (ES) 167 3
EMA 104 1
AIFA (IT) 51 None
INFARMED (PT) 26 None
ANSM (FR) 15 None
MPA (SE) 9 None
ANVISA (Brazil) None 1
EAEU_EEC None 1

Questions about Laboratorio Reig Jofre

Does Laboratorio Reig Jofre hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Laboratorio Reig Jofre. It does have 391 filings with 14 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Laboratorio Reig Jofre FDA-registered?
2 sites operated by Laboratorio Reig Jofre carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Laboratorio Reig Jofre's last inspection go?
The most recent inspection on record closed on 23 June 2023 as OAI (Official Action Indicated, the worst classification: objectionable conditions were found and regulatory action was warranted). 4 inspections are on file, of which 3 closed as OAI.
Where does Laboratorio Reig Jofre manufacture?
8 registered sites are on record, in United Arab Emirates and Spain (Barcelona, Barcelona and Toledo among others). Every site is listed on this page with the register it came from.
Which regulators recognise Laboratorio Reig Jofre's GMP?
Current GMP certificates are on record from AEMPS (ES), ANVISA (Brazil), EEC (Eurasian Economic Union) 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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Open risk flags

  • The most recent inspection outcome was OAI, on 23 June 2023.

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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