Suppliers / Gador S A

Gador S A

Argentina 3 duplicate records merged Updated 9 July 2026

Gador S A is an API and finished-dose manufacturer based in Argentina. It holds 4 active US drug master files across a filed portfolio of 3 molecules. Its filings concentrate with ANMAT (AR), ARCSA (EC) and ISP (CL). Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 3 August 2018 as VAI.

4
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
218
filings across 8 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 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

  • 3 August 2018 VAI US FDA
  • 22 May 2014 NAI US FDA
  • 26 May 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
Argentina, Argentina 3003276678
Pilar, Argentina Not on file
Buenos Aires, Argentina Not on file
BELO HORIZONTE, Brazil Not on file

What they file, and where

Molecule Regulators Docs
Pamidronic Acid US FDA 2
Norgestimate US FDA 1
Zoledronic Acid US FDA 1

Also appears on these molecule pages

Apalutamide finished dose Bictegravir finished dose Cabozantinib finished dose Carfilzomib finished dose Carmustine finished dose Clarithromycin finished dose Dacarbazine finished dose Desvenlafaxine finished dose Dienogest finished dose Diosmin finished dose Eliglustat finished dose Estetrol finished dose
Show 11 more molecule pages
Eszopiclone finished dose Ifosfamide finished dose Ivacaftor finished dose Mirabegron finished dose Norgestimate API Perampanel finished dose Pimavanserin finished dose Sofosbuvir finished dose Tenofovir Alafenamide finished dose Tolvaptan finished dose Zoledronic Acid API

Filings and GMP by regulator

Regulator Filings GMP certificates
ANMAT (AR) 98 None
ARCSA (EC) 55 None
ISP (CL) 28 None
DIGEMAPS (DO) 15 None
INVIMA (CO) 9 None
MINSA (CR) 7 None
EMA None 1

Questions about Gador S A

Does Gador S A hold a US DMF or a CEP?
Gador S A holds 4 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 Gador S A FDA-registered?
One site operated by Gador S A 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 Gador S A's last inspection go?
The most recent inspection on record closed on 3 August 2018 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Gador S A manufacture?
4 registered sites are on record, in Argentina and Brazil (Argentina, Pilar and Buenos Aires among others). Every site is listed on this page with the register it came from.
What does Gador S A make?
3 molecules are on record against Gador S A, including Pamidronic Acid, Norgestimate and Zoledronic Acid. Each links through to that molecule's full manufacturer list.
Which regulators recognise Gador S A's GMP?
Current GMP certificates are on record from 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

  • The most recent inspection outcome was VAI, on 3 August 2018.

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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