Changzhou Qianhong Bio Pharma
China 88 employees Updated 9 July 2026
Changzhou Qianhong Bio Pharma is an API manufacturer based in China. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its GMP standing is certified by MFDS (Korea), US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 31 October 2025 as VAI.
2
registered plants
1 with an FDA FEI number
2
filings
across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
6 of 6 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
- 31 October 2025 VAI US FDA
- 10 May 2023 VAI US FDA
- 23 October 2019 NAI US FDA
- 15 December 2017 VAI US FDA
- 1 August 2014 VAI US FDA
- 30 April 2010 NAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Changzhou, China | Not on file |
| China, China | 3005275502 |
What they file, and where
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| MINSA (CR) | 2 | None |
| MFDS (Korea) | None | 2 |
| US FDA | None | 1 |
| EMA | None | 1 |
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Open risk flags
- The most recent inspection outcome was VAI, on 31 October 2025.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates