Suppliers / Farmhispania

Farmhispania

Spain 2 duplicate records merged Updated 9 July 2026

Farmhispania is an API manufacturer based in Spain. It holds 17 active US drug master files across a filed portfolio of 15 molecules. Its GMP standing is certified by US FDA, AEMPS (ES) and EMA. Its most recent recorded inspection, by US FDA, closed on 12 May 2023 as VAI.

17
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
3
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 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

  • 12 May 2023 VAI US FDA
  • 16 March 2018 VAI US FDA
  • 15 January 2016 VAI US FDA
  • 12 December 2012 VAI US FDA
  • 29 April 2009 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, Spain Not on file
Spain, Spain 3002806964

What they file, and where

Molecule Regulators Docs
Rocuronium SFDA (Saudi Arabia), US FDA 5
Metformin SFDA (Saudi Arabia), US FDA 3
Atracurium Besylate SFDA (Saudi Arabia), US FDA 2
Everolimus US FDA 2
Milrinone SFDA (Saudi Arabia), US FDA 2
Benazepril US FDA 1
Cisatracurium US FDA 1
Decitabine US FDA 1
Deutetrabenazine US FDA 1
Enalapril US FDA 1
Show all 15 molecules on file
Gemcitabine US FDA 1
Pemetrexed SFDA (Saudi Arabia) 1
Quinapril US FDA 1
Sugammadex US FDA 1
Tacrolimus US FDA 1

Also appears on these molecule pages

Atracurium API Benazepril API Cisatracurium API Decitabine API Deutetrabenazine API Enalapril API Everolimus API Gemcitabine API Metformin API Milrinone API Pemetrexed API Quinapril API
Show 3 more molecule pages
Rocuronium API Sugammadex API Tacrolimus API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 3 None
US FDA None 1
AEMPS (ES) None 1
EMA None 1

Questions about Farmhispania

Does Farmhispania hold a US DMF or a CEP?
Farmhispania holds 17 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 Farmhispania FDA-registered?
One site operated by Farmhispania 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 Farmhispania's last inspection go?
The most recent inspection on record closed on 12 May 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Farmhispania manufacture?
2 registered sites are on record, in Spain (Barcelona and Spain). Every site is listed on this page with the register it came from.
What does Farmhispania make?
15 molecules are on record against Farmhispania, including Rocuronium, Metformin, Atracurium Besylate and Everolimus. Each links through to that molecule's full manufacturer list.
Which regulators recognise Farmhispania's GMP?
Current GMP certificates are on record from US FDA, AEMPS (ES) 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

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was VAI, on 12 May 2023.

Comparable suppliers

Apitoria Pharma shares 5 molecules Dr Reddy's Laboratories shares 5 molecules MSN Laboratories shares 4 molecules Zhejiang Huahai Pharmaceutical shares 4 molecules Gland Pharma shares 4 molecules

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