Xinyu Pharmaceutical Co.,Ltd
China Updated 9 July 2026
Xinyu Pharmaceutical Co.,Ltd is an API manufacturer based in China. It holds 6 active US drug master files across a filed portfolio of 2 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 27 June 2025 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
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 27 June 2025 VAI US FDA
- 15 March 2019 VAI US FDA
- 14 September 2016 VAI US FDA
- 14 March 2013 NAI US FDA
- 12 March 2010 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 | 3006895831 |
What they file, and where
| Molecule | Regulators | Docs |
| Clindamycin | US FDA | 4 |
| Lincomycin | US FDA | 2 |
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 27 June 2025.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates