Suppliers / Interquim

Interquim

Mexico reconciled across 7 public records · 1 entities Updated 9 July 2026

Interquim is an API manufacturer based in Mexico. It holds 24 active US drug master files across a filed portfolio of 26 molecules. Its GMP standing is certified by EDQM, COFEPRIS (MX) and US FDA. Its most recent recorded inspection, by US FDA, closed on 6 September 2024 as VAI.

24
active US DMFs
0
valid CEPs
3
registered plants 2 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 6 September 2024 VAI US FDA
  • 16 December 2022 NAI US FDA
  • 27 September 2019 VAI US FDA
  • 20 December 2018 VAI US FDA
  • 2 June 2017 VAI US FDA
  • 6 May 2016 OAI US FDA
  • 19 June 2015 VAI US FDA
  • 11 October 2013 VAI US FDA
  • 9 September 2011 VAI US FDA

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

Registered plants

Site FDA FEI
Spain, Spain 3002807304
Mexico, Mexico 3005170172
Cuautitlán Izcalli, Mexico Not on file

What they file, and where

Molecule Regulators Docs
Imiquimod SFDA (Saudi Arabia), US FDA 3
Paliperidone SFDA (Saudi Arabia), US FDA 3
Aripiprazole US FDA 2
Celecoxib SFDA (Saudi Arabia), US FDA 2
Ozenoxacin SFDA (Saudi Arabia), US FDA 2
Rivastigmine SFDA (Saudi Arabia), US FDA 2
Aripiprazole Lauroxil US FDA 1
Ciclopirox US FDA 1
Dexmedetomidine US FDA 1
Diacerein SFDA (Saudi Arabia) 1
Show all 26 molecules on file
Diosmin SFDA (Saudi Arabia) 1
Edaravone US FDA 1
Ferric Carboxymaltose US FDA 1
Fosfomycin US FDA 1
Lifitegrast US FDA 1
Pyrimethamine US FDA 1
Rasagiline SFDA (Saudi Arabia) 1
Risperidone US FDA 1
Rivaroxaban US FDA 1
Roflumilast US FDA 1
Rotigotine US FDA 1
Sertaconazole US FDA 1
Solifenacin Succinate US FDA 1
Telmisartan SFDA (Saudi Arabia) 1
Tiamulin US FDA 1
Tolterodine US FDA 1

Also appears on these molecule pages

Show 7 more molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
EDQM None 10
COFEPRIS (MX) None 2
US FDA None 1

Questions about Interquim

Does Interquim hold a US DMF or a CEP?
Interquim holds 24 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 Interquim FDA-registered?
2 sites operated by Interquim 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 Interquim's last inspection go?
The most recent inspection on record closed on 6 September 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 9 inspections are on file, of which 1 closed as OAI.
Where does Interquim manufacture?
3 registered sites are on record, in Spain and Mexico (Spain, Mexico and Cuautitlán Izcalli). Every site is listed on this page with the register it came from.
What does Interquim make?
26 molecules are on record against Interquim, including Imiquimod, Paliperidone, Aripiprazole and Celecoxib. Each links through to that molecule's full manufacturer list.
Which regulators recognise Interquim's GMP?
Current GMP certificates are on record from EDQM, COFEPRIS (MX) and US FDA. 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

  • 4 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 6 September 2024.

Sources on this page

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