Suppliers / Esteve Huayi Pharmaceutical

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.

1
active US DMFs
0
valid CEPs
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
Plants
1 of 1 confirmed
Inspections
4 of 4 confirmed
EU GMP
1 of 1 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

Bictegravir API Ibrutinib API

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 1 None
EMA None 2
US FDA None 1

Questions about Esteve Huayi Pharmaceutical

Does Esteve Huayi Pharmaceutical hold a US DMF or a CEP?
Esteve Huayi Pharmaceutical holds 1 active US drug master file. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Esteve Huayi Pharmaceutical FDA-registered?
One site operated by Esteve Huayi Pharmaceutical carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Esteve Huayi Pharmaceutical's last inspection go?
The most recent inspection on record closed on 14 March 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Esteve Huayi Pharmaceutical manufacture?
2 registered sites are on record, in China (China and Zhejiang). Every site is listed on this page with the register it came from.
What does Esteve Huayi Pharmaceutical make?
3 molecules are on record against Esteve Huayi Pharmaceutical, including Bictegravir, Ibrutinib and Remdesivir. Each links through to that molecule's full manufacturer list.
Which regulators recognise Esteve Huayi Pharmaceutical's GMP?
Current GMP certificates are on record from EMA and US FDA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was VAI, on 14 March 2025.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates