Tolmar
United States 931 employees Updated 9 July 2026
Tolmar is a finished-dose manufacturer based in United States. It appears in 35 regulatory filings across 8 regulators, without an active US DMF or CEP on file. Its filings concentrate with US FDA, ARCSA (EC) and DIGEMAPS (DO). Its GMP standing is certified by ANVISA (Brazil) and US FDA. Its most recent recorded inspection, by US FDA, closed on 23 February 2024 as VAI.
3
registered plants
2 with an FDA FEI number
35
filings
across 8 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
- 23 February 2024 VAI US FDA
- 31 January 2023 VAI US FDA
- 31 January 2023 NAI US FDA
- 24 February 2020 VAI US FDA
- 28 January 2020 VAI US FDA
- 6 April 2018 VAI US FDA
- 6 December 2017 VAI US FDA
- 26 July 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 |
| Fort Collins, United States | 3006218434 |
| FORT COLLINS, United States | Not on file |
| Windsor, United States | 3010755927 |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| US FDA | 15 | 1 |
| ARCSA (EC) | 9 | None |
| DIGEMAPS (DO) | 4 | None |
| NPRA (MY) | 3 | None |
| Health Canada | 1 | None |
| MINSA (CR) | 1 | None |
| ANVISA (Brazil) | None | 3 |
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Open risk flags
- The most recent inspection outcome was VAI, on 23 February 2024.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates