Fujian Fukang Pharmaceutical
China Updated 9 July 2026
Fujian Fukang Pharmaceutical is an API manufacturer based in China. It holds 5 active US drug master files across a filed portfolio of 4 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 12 April 2024 as NAI.
2
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
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.
Inspection history
- 12 April 2024 NAI US FDA
- 26 July 2018 VAI US FDA
- 28 March 2014 VAI US FDA
- 23 September 2011 NAI US FDA
- 19 February 2009 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| China, China | 3004752070 |
| Fuzhou, China | Not on file |
What they file, and where
| Molecule | Regulators | Docs |
| Gentamicin | SFDA (Saudi Arabia), US FDA | 2 |
| Oseltamivir | US FDA | 2 |
| Chlortetracycline | US FDA | 1 |
| Tetracycline | US FDA | 1 |
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| EMA | None | 1 |
| US FDA | None | 1 |
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Open risk flags
- The most recent inspection outcome was NAI, on 12 April 2024.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates