Esteve Huayi Pharmaceutical
China Updated 9 July 2026
Esteve Huayi Pharmaceutical is an API manufacturer based in China. It holds one active US drug master file across a filed portfolio of 3 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 14 March 2025 as VAI.
2
registered plants
1 with an FDA FEI number
1
filings
across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
4 of 4 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
- 14 March 2025 VAI US FDA
- 23 January 2019 VAI US FDA
- 20 March 2015 NAI US FDA
- 6 January 2012 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 | 3008705620 |
| Zhejiang, China | Not on file |
What they file, and where
| Molecule | Regulators | Docs |
| Bictegravir | SFDA (Saudi Arabia) | 1 |
| Ibrutinib | US FDA | 1 |
| Remdesivir | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| AIFA (IT) | 1 | None |
| EMA | None | 2 |
| US FDA | None | 1 |
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Open risk flags
- The most recent inspection outcome was VAI, on 14 March 2025.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates