Ultragenyx Pharmaceutical
United States Updated 9 July 2026
Ultragenyx Pharmaceutical is an API manufacturer based in United States. It holds one active US drug master file. Its filings concentrate with Health Canada and US FDA. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 17 July 2025 as NAI.
1
registered plants
1 with an FDA FEI number
7
filings
across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 17 July 2025 NAI US FDA
- 27 February 2023 NAI US FDA
- 20 June 2017 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Novato, United States | 3012208691 |
What they file, and where
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| Health Canada | 5 | None |
| US FDA | 2 | 1 |
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Open risk flags
- The most recent inspection outcome was NAI, on 17 July 2025.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates