Suppliers / Huatai Pharma

Huatai Pharma

China Updated 9 July 2026

Huatai Pharma is an API manufacturer based in China. It holds one active US drug master file. Its most recent recorded inspection, by US FDA, closed on 24 March 2023 as VAI.

1
active US DMFs
0
valid CEPs
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
Plants
1 of 1 confirmed
Inspections
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 24 March 2023 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 3012212599

What they file, and where

Molecule Regulators Docs
Icosapent Ethyl US FDA 1

Also appears on these molecule pages

Icosapent Ethyl API

Questions about Huatai Pharma

Does Huatai Pharma hold a US DMF or a CEP?
Huatai Pharma 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 Huatai Pharma FDA-registered?
One site operated by Huatai Pharma 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 Huatai Pharma's last inspection go?
The most recent inspection on record closed on 24 March 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Huatai Pharma manufacture?
1 registered site is on record, in China (China). Every site is listed on this page with the register it came from.
What does Huatai Pharma make?
1 molecule is on record against Huatai Pharma, including Icosapent Ethyl. Each links through to that molecule's full manufacturer list.

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 24 March 2023.

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability