Hunan Dongting Pharmaceutical
China Updated 9 July 2026
Hunan Dongting Pharmaceutical is an API manufacturer based in China. It holds one active US drug master file and one valid CEP. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 24 May 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
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 24 May 2024 NAI US FDA
- 6 March 2015 NAI US FDA
- 15 September 2011 NAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Changde, China | Not on file |
| China, China | 3004753289 |
What they file, and where
| Molecule | Regulators | Docs |
| Tranexamic Acid | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
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 NAI, on 24 May 2024.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates