Suppliers / Umicore Argentina

Umicore Argentina

Argentina 2 duplicate records merged Updated 9 July 2026

Umicore Argentina is an API manufacturer based in Argentina. It holds 4 active US drug master files across a filed portfolio of 4 molecules. Its GMP standing is certified by ZLG (DE). Its most recent recorded inspection, by US FDA, closed on 11 May 2018 as VAI.

4
active US DMFs
0
valid CEPs
2
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
2 of 2 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 11 May 2018 VAI US FDA
  • 26 February 2016 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 3009867894
Hanau-Wolfgang, Germany Not on file

What they file, and where

Molecule Regulators Docs
Arsenic Trioxide SFDA (Saudi Arabia), US FDA 2
Carboplatin SFDA (Saudi Arabia), US FDA 2
Oxaliplatin SFDA (Saudi Arabia), US FDA 2
Cisplatin US FDA 1

Also appears on these molecule pages

Carboplatin API

Filings and GMP by regulator

Regulator Filings GMP certificates
ZLG (DE) None 2

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Open risk flags

  • The most recent inspection outcome was VAI, on 11 May 2018.

Sources on this page

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