Suppliers / Xttrium Laboratories

Xttrium Laboratories

United States 122 employees Updated 9 July 2026

Xttrium Laboratories is an API and finished-dose manufacturer based in United States. It holds one active US drug master file and one valid CEP across a filed portfolio of 2 molecules. Its most recent recorded inspection, by US FDA, closed on 18 June 2025 as OAI.

1
active US DMFs
1
valid CEPs
2
registered plants 2 with an FDA FEI number
9
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 June 2025 OAI US FDA
  • 8 March 2024 VAI US FDA
  • 6 February 2024 NAI US FDA
  • 15 March 2018 VAI US FDA
  • 11 July 2016 VAI US FDA
  • 25 May 2016 VAI US FDA
  • 5 December 2013 VAI US FDA
  • 15 January 2013 NAI US FDA

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

Registered plants

Site FDA FEI
Lake Villa, United States 3017764383
Mount Prospect, United States 3008436464

What they file, and where

Molecule Regulators Docs
Chlorhexidine US FDA 1
Chlorhexidine Digluconate EDQM 1

Also appears on these molecule pages

Chlorhexidine API Megestrol finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 9 None

Questions about Xttrium Laboratories

Does Xttrium Laboratories hold a US DMF or a CEP?
Xttrium Laboratories holds 1 active US drug master file and 1 valid CEP. 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 Xttrium Laboratories FDA-registered?
2 sites operated by Xttrium Laboratories 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 Xttrium Laboratories's last inspection go?
The most recent inspection on record closed on 18 June 2025 as OAI (Official Action Indicated, the worst classification: objectionable conditions were found and regulatory action was warranted). 8 inspections are on file, of which 1 closed as OAI.
Where does Xttrium Laboratories manufacture?
2 registered sites are on record, in United States (Lake Villa and Mount Prospect). Every site is listed on this page with the register it came from.
What does Xttrium Laboratories make?
2 molecules are on record against Xttrium Laboratories, including Chlorhexidine and Chlorhexidine Digluconate. Each links through to that molecule's full manufacturer list.
Where does Xttrium Laboratories file?
Filings are on record with US FDA, 9 in total.

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 OAI, on 18 June 2025.

Comparable suppliers

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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