Itf Chemical Ltda
Brazil Updated 9 July 2026
Itf Chemical Ltda is an API manufacturer based in Brazil. It holds 5 active US drug master files across a filed portfolio of 5 molecules. Its most recent recorded inspection, by US FDA, closed on 9 September 2022 as NAI.
1
registered plants
1 with an FDA FEI number
1
filings
across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 9 September 2022 NAI US FDA
- 8 December 2016 VAI US FDA
- 28 March 2014 VAI US FDA
- 4 August 2011 NAI US FDA
- 13 November 2008 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Brazil, Brazil | 3004447173 |
What they file, and where
| Molecule | Regulators | Docs |
| Azacitidine | US FDA | 1 |
| Decitabine | US FDA | 1 |
| Levofloxacin | US FDA | 1 |
| Rosiglitazone | US FDA | 1 |
| Temozolomide | US FDA | 1 |
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| MINSA (CR) | 1 | None |
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Open risk flags
- The most recent inspection outcome was NAI, on 9 September 2022.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability