Suppliers / Derivados Quimicos SAU

Derivados Quimicos SAU

Spain Updated 9 July 2026

Derivados Quimicos SAU is an API manufacturer based in Spain. It holds 9 active US drug master files across a filed portfolio of 9 molecules. Its most recent recorded inspection, by US FDA, closed on 2 February 2023 as VAI.

9
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 2 February 2023 VAI US FDA
  • 14 June 2018 VAI US FDA
  • 23 October 2015 VAI US FDA
  • 15 November 2012 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 3003468553

What they file, and where

Molecule Regulators Docs
Meloxicam SFDA (Saudi Arabia), US FDA 2
Butoconazole US FDA 1
Cicletanine US FDA 1
Cyclobenzaprine US FDA 1
Fenofibrate US FDA 1
Ketoconazole US FDA 1
Milnacipran US FDA 1
Racepinephrine US FDA 1
Terconazole US FDA 1

Also appears on these molecule pages

Cyclobenzaprine API Fenofibrate API Ketoconazole API Meloxicam API Milnacipran API

Questions about Derivados Quimicos SAU

Does Derivados Quimicos SAU hold a US DMF or a CEP?
Derivados Quimicos SAU holds 9 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 Derivados Quimicos SAU FDA-registered?
One site operated by Derivados Quimicos SAU 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 Derivados Quimicos SAU's last inspection go?
The most recent inspection on record closed on 2 February 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Derivados Quimicos SAU manufacture?
1 registered site is on record, in Spain (Spain). Every site is listed on this page with the register it came from.
What does Derivados Quimicos SAU make?
9 molecules are on record against Derivados Quimicos SAU, including Meloxicam, Butoconazole, Cicletanine and Cyclobenzaprine. Each links through to that molecule's full manufacturer list.

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 2 February 2023.

Comparable suppliers

Hetero shares 3 molecules Ipca Laboratories shares 2 molecules Macleods Pharmaceuticals shares 2 molecules Lupin shares 2 molecules Quimica Sintetica shares 2 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