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.
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
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
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| US FDA | 9 | None |
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Open risk flags
- The most recent inspection outcome was OAI, on 18 June 2025.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability