Suppliers / Pharma Mar

Pharma Mar

Spain Updated 9 July 2026

Pharma Mar is an API manufacturer based in Spain. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its filings concentrate with EMA, FAMHP (BE) and MPA (SE). Its GMP standing is certified by EMA and AEMPS (ES). Its most recent recorded inspection, by US FDA, closed on 26 January 2023 as VAI.

2
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
31
filings across 9 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

  • 26 January 2023 VAI US FDA
  • 21 February 2019 VAI US FDA
  • 24 April 2015 VAI US FDA
  • 30 July 2009 NAI US FDA

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

Registered plants

Site FDA FEI
madrid, United Arab Emirates Not on file
Madrid, Spain Not on file
Spain, Spain 3004983316
Colmenar Viejo, Spain Not on file

What they file, and where

Molecule Regulators Docs
Lurbinectedin SFDA (Saudi Arabia), US FDA 2
Trabectedin SFDA (Saudi Arabia), US FDA 2

Also appears on these molecule pages

Lurbinectedin API Trabectedin API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 6 1
FAMHP (BE) 4 None
MPA (SE) 4 None
INFARMED (PT) 4 None
AEMPS (ES) 4 1
AIFA (IT) 4 None

Questions about Pharma Mar

Does Pharma Mar hold a US DMF or a CEP?
Pharma Mar holds 2 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.
Is Pharma Mar FDA-registered?
One site operated by Pharma Mar 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 Pharma Mar's last inspection go?
The most recent inspection on record closed on 26 January 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Pharma Mar manufacture?
4 registered sites are on record, in United Arab Emirates and Spain (Madrid, Madrid and Spain among others). Every site is listed on this page with the register it came from.
What does Pharma Mar make?
2 molecules are on record against Pharma Mar, including Lurbinectedin and Trabectedin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Pharma Mar'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 26 January 2023.

Comparable suppliers

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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