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 Cisplatin API Oxaliplatin API

Filings and GMP by regulator

Regulator Filings GMP certificates
ZLG (DE) None 2

Questions about Umicore Argentina

Does Umicore Argentina hold a US DMF or a CEP?
Umicore Argentina 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 Umicore Argentina FDA-registered?
One site operated by Umicore Argentina 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 Umicore Argentina's last inspection go?
The most recent inspection on record closed on 11 May 2018 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Umicore Argentina manufacture?
2 registered sites are on record, in Argentina and Germany (Argentina and Hanau-wolfgang). Every site is listed on this page with the register it came from.
What does Umicore Argentina make?
4 molecules are on record against Umicore Argentina, including Arsenic Trioxide, Carboplatin, Oxaliplatin and Cisplatin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Umicore Argentina's GMP?
Current GMP certificates are on record from ZLG (DE). 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 11 May 2018.

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Sources on this page

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