Suppliers / Curium US

Curium US

United States Updated 9 July 2026

Curium US is an API manufacturer based in United States. It holds 9 active US drug master files across a filed portfolio of 9 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 18 April 2025 as VAI.

9
active US DMFs
0
valid CEPs
2
registered plants 2 with an FDA FEI number
18
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 18 April 2025 VAI US FDA
  • 18 August 2023 VAI US FDA
  • 14 June 2019 NAI US FDA
  • 13 November 2015 VAI US FDA
  • 18 June 2014 NAI US FDA
  • 27 March 2013 NAI US FDA
  • 6 August 2012 VAI US FDA
  • 25 May 2011 NAI US FDA

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

Registered plants

Site FDA FEI
Noblesville, United States 3011400787
Maryland Heights, United States 1946929

What they file, and where

Molecule Regulators Docs
Copper Oxodotreotide Cu-64 US FDA 1
Cupric Chloride US FDA 1
Gallium Chloride Ga-67 US FDA 1
Indium US FDA 1
Indium In-111 Chloride US FDA 1
Iodide I-123 US FDA 1
Leucine US FDA 1
Molybdate US FDA 1
Pentetic Acid US FDA 1

Also appears on these molecule pages

Leucine API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 18 2

Questions about Curium US

Does Curium US hold a US DMF or a CEP?
Curium US 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 Curium US FDA-registered?
2 sites operated by Curium US 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 Curium US's last inspection go?
The most recent inspection on record closed on 18 April 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Curium US manufacture?
2 registered sites are on record, in United States (Noblesville and Maryland Heights). Every site is listed on this page with the register it came from.
What does Curium US make?
9 molecules are on record against Curium US, including Copper Oxodotreotide Cu-64, Cupric Chloride, Gallium Chloride Ga-67 and Indium. Each links through to that molecule's full manufacturer list.
Which regulators recognise Curium US's GMP?
Current GMP certificates are on record from 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

  • The most recent inspection outcome was VAI, on 18 April 2025.

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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