ScieGen Pharmaceuticals
United States 175 employees Updated 9 July 2026
ScieGen Pharmaceuticals is a finished-dose manufacturer based in United States. It appears in 39 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with US FDA, DMP (NO) and SFDA (Saudi Arabia). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 19 December 2025 as NAI.
1
registered plants
1 with an FDA FEI number
39
filings
across 3 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
- 19 December 2025 NAI US FDA
- 20 February 2024 NAI US FDA
- 21 April 2023 OAI US FDA
- 2 September 2022 VAI US FDA
- 20 December 2021 VAI US FDA
- 21 June 2019 VAI US FDA
- 20 April 2018 NAI US FDA
- 16 March 2018 NAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Hauppauge, United States | 3008298016 |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| US FDA | 31 | 1 |
| DMP (NO) | 6 | None |
| SFDA (Saudi Arabia) | 2 | None |
Comparing suppliers?
Choose your molecules and target markets. ScieGen Pharmaceuticals comes back tiered against every other
supplier able to file there.
Start for free No sales call.
Open risk flags
- The most recent inspection outcome was NAI, on 19 December 2025.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates