Tris Pharma
United States 494 employees Updated 9 July 2026
Tris Pharma is a finished-dose manufacturer based in United States. It holds 6 active US drug master files across a filed portfolio of 2 molecules. Its filings concentrate with US FDA and NMPA (CN). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 21 November 2025 as VAI.
1
registered plants
1 with an FDA FEI number
35
filings
across 2 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
- 21 November 2025 VAI US FDA
- 8 March 2024 VAI US FDA
- 8 June 2021 VAI US FDA
- 23 January 2019 OAI US FDA
- 16 April 2018 VAI US FDA
- 20 March 2017 OAI US FDA
- 27 January 2016 NAI US FDA
- 12 August 2015 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Monmouth Junction, United States | 3004712471 |
What they file, and where
| Molecule | Regulators | Docs |
| Methylphenidate | US FDA | 4 |
| Gamma-Hydroxybutyric Acid | US FDA | 2 |
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| US FDA | 29 | 1 |
| NMPA (CN) | 6 | None |
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Open risk flags
- 25 active litigation matters are on record.
- The most recent inspection outcome was VAI, on 21 November 2025.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates