Suppliers / Lianyungang Kangle Pharmaceutical
Lianyungang Kangle Pharmaceutical
China Updated 9 July 2026
Lianyungang Kangle Pharmaceutical is an API manufacturer based in China. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 19 September 2025 as VAI.
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. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.
Inspection history
- 19 September 2025 VAI US FDA
- 31 May 2019 VAI US FDA
- 15 July 2016 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Lianyungang, Jiangsu Province, China | Not on file |
| China, China | 3010728729 |
What they file, and where
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 VAI, on 19 September 2025.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates