Suppliers / Quimica Sintetica

Quimica Sintetica

Spain 315 employees 2 duplicate records merged Updated 9 July 2026

Quimica Sintetica is an API manufacturer based in Spain. It holds 41 active US drug master files. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 9 November 2023 as VAI.

41
active US DMFs
0
valid CEPs
4
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
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

  • 9 November 2023 VAI US FDA
  • 6 April 2022 VAI US FDA
  • 17 May 2019 VAI US FDA
  • 22 March 2019 VAI US FDA
  • 6 December 2016 VAI US FDA
  • 9 September 2016 VAI US FDA
  • 21 November 2014 VAI US FDA
  • 31 October 2013 NAI US FDA

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

Registered plants

Site FDA FEI
MENDRISIO, Switzerland Not on file
Switzerland, Switzerland 3004058163
Couvet, Switzerland Not on file
Spain, Spain 3002807965

What they file, and where

Molecule Regulators Docs
Ciprofloxacin SFDA (Saudi Arabia), US FDA 3
Ketorolac SFDA (Saudi Arabia), US FDA 3
Apremilast US FDA 2
Famotidine SFDA (Saudi Arabia), US FDA 2
Indapamide SFDA (Saudi Arabia), US FDA 2
Irbesartan SFDA (Saudi Arabia) 2
Lansoprazole US FDA 2
Levofloxacin SFDA (Saudi Arabia), US FDA 2
Ofloxacin SFDA (Saudi Arabia), US FDA 2
Acyclovir US FDA 1
Show all 30 molecules on file
Benznidazole US FDA 1
Captopril US FDA 1
Chloramphenicol US FDA 1
Droxidopa US FDA 1
Edaravone US FDA 1
Eltrombopag US FDA 1
Fluconazole US FDA 1
Fluoxetine US FDA 1
Fosfomycin US FDA 1
Guanfacine US FDA 1
Isradipine US FDA 1
Itraconazole US FDA 1
Ketoconazole US FDA 1
Levomilnacipran US FDA 1
Loratadine US FDA 1
Meloxicam US FDA 1
Miconazole US FDA 1
Omeprazole US FDA 1
Pantoprazole US FDA 1
Posaconazole US FDA 1

Also appears on these molecule pages

Acyclovir API Captopril API Ciprofloxacin API Droxidopa API Edaravone API Eltrombopag API Famotidine API Fluconazole API Fluoxetine API Fosfomycin API Guanfacine API Indapamide API
Show 20 more molecule pages
Isradipine API Itraconazole API Ketoconazole API Ketorolac Tromethamine API Lansoprazole API Levofloxacin API Levomilnacipran API Loratadine API Meloxicam API Miconazole API Ofloxacin API Posaconazole API Rabeprazole API Sumatriptan API Tamsulosin API Terbinafine API Omeprazole API Pantoprazole API Irbesartan API Apremilast API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 4
US FDA None 1

Questions about Quimica Sintetica

Does Quimica Sintetica hold a US DMF or a CEP?
Quimica Sintetica holds 41 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 Quimica Sintetica FDA-registered?
2 sites operated by Quimica Sintetica 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 Quimica Sintetica's last inspection go?
The most recent inspection on record closed on 9 November 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Quimica Sintetica manufacture?
4 registered sites are on record, in Switzerland and Spain (Mendrisio, Switzerland and Couvet among others). Every site is listed on this page with the register it came from.
What does Quimica Sintetica make?
30 molecules are on record against Quimica Sintetica, including Ciprofloxacin, Ketorolac, Apremilast and Famotidine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Quimica Sintetica's GMP?
Current GMP certificates are on record from EMA 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

  • 8 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 9 November 2023.

Comparable suppliers

Dr Reddy's Laboratories shares 12 molecules Apitoria Pharma shares 10 molecules Zydus Lifesciences shares 9 molecules Hetero shares 7 molecules Cipla shares 7 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