Suppliers / Tris Pharma

Tris Pharma

United States 494 employees Updated 9 July 2026

Tris Pharma is an API and 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.

6
active US DMFs
0
valid CEPs
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
Plants
1 of 1 confirmed
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

Clonidine finished dose Febuxostat finished dose Ganirelix finished dose Methylphenidate API Paliperidone finished dose Pregabalin finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 29 1
NMPA (CN) 6 None

Questions about Tris Pharma

Does Tris Pharma hold a US DMF or a CEP?
Tris Pharma holds 6 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Tris Pharma FDA-registered?
One site operated by Tris Pharma carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Tris Pharma's last inspection go?
The most recent inspection on record closed on 21 November 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file, of which 2 closed as OAI.
Where does Tris Pharma manufacture?
1 registered site is on record, in United States (Monmouth Junction). Every site is listed on this page with the register it came from.
What does Tris Pharma make?
2 molecules are on record against Tris Pharma, including Methylphenidate and Gamma-Hydroxybutyric Acid. Each links through to that molecule's full manufacturer list.
Which regulators recognise Tris Pharma's GMP?
Current GMP certificates are on record from US FDA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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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.

Comparable suppliers

Ipca Laboratories shares 1 molecule Cohance Lifesciences shares 1 molecule Specgx shares 1 molecule Harman Finochem shares 1 molecule Centaur Pharmaceuticals shares 1 molecule

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates