Suppliers / Tolmar

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.

0
active US DMFs
0
valid CEPs
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
Plants
2 of 2 confirmed
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
INFARMED (PT) 1 None
MINSA (CR) 1 None
ANVISA (Brazil) None 3

Questions about Tolmar

Does Tolmar hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Tolmar. It does have 35 filings with 8 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Tolmar FDA-registered?
2 sites operated by Tolmar carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Tolmar's last inspection go?
The most recent inspection on record closed on 23 February 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Tolmar manufacture?
3 registered sites are on record, in United States (Fort Collins, Fort Collins and Windsor). Every site is listed on this page with the register it came from.
Which regulators recognise Tolmar's GMP?
Current GMP certificates are on record from ANVISA (Brazil) and 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

  • The most recent inspection outcome was VAI, on 23 February 2024.

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Sources on this page

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