Nortec Quimica
Brazil Updated 9 July 2026
Nortec Quimica is an API manufacturer based in Brazil. It holds 4 active US drug master files across a filed portfolio of 5 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 4 August 2023 as VAI.
1
registered plants
1 with an FDA FEI number
0
filings
across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 4 August 2023 VAI US FDA
- 22 July 2022 OAI US FDA
- 8 December 2016 NAI 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 | 3007616930 |
What they file, and where
| Molecule | Regulators | Docs |
| Prilocaine | SFDA (Saudi Arabia), US FDA | 4 |
| Bupivacaine | US FDA | 1 |
| Esketamine | US FDA | 1 |
| Mepivacaine | SFDA (Saudi Arabia) | 1 |
| Spironolactone | US FDA | 1 |
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| US FDA | None | 1 |
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Open risk flags
- The most recent inspection outcome was VAI, on 4 August 2023.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates