Hovione Scientia
United States Updated 9 July 2026
Hovione Scientia is an API manufacturer based in United States. It appears in 3 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by EMA, US FDA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 11 June 2025 as NAI.
3
registered plants
2 with an FDA FEI number
3
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. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.
Inspection history
- 11 June 2025 NAI US FDA
- 20 January 2023 NAI US FDA
- 22 February 2022 VAI US FDA
- 22 January 2020 VAI US FDA
- 22 December 2017 NAI US FDA
- 16 December 2015 VAI US FDA
- 25 July 2014 NAI US FDA
- 26 April 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 |
| Ireland, Ireland | 3008058822 |
| EAST WINDSOR, United States | Not on file |
| East Windsor, United States | 3006106736 |
What they file, and where
| Molecule | Regulators | Docs |
| Doxycycline | SFDA (Saudi Arabia) | 1 |
| Minocycline | SFDA (Saudi Arabia) | 1 |
| Regadenoson | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| INFARMED (PT) | 3 | None |
| EMA | None | 2 |
| US FDA | None | 1 |
| ANVISA (Brazil) | None | 1 |
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Open risk flags
- The most recent inspection outcome was NAI, on 11 June 2025.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates