Suppliers / Hubei Zhuxi Humanwell Pharmaceutical

Hubei Zhuxi Humanwell Pharmaceutical

China Updated 9 July 2026

Hubei Zhuxi Humanwell Pharmaceutical is an API manufacturer based in China. It holds 4 active US drug master files across a filed portfolio of 4 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 1 December 2023 as NAI.

4
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

  • 1 December 2023 NAI 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 3012129618

What they file, and where

Molecule Regulators Docs
Abiraterone US FDA 1
Testosterone US FDA 1
Testosterone Cypionate US FDA 1
Testosterone Undecanoate US FDA 1

Also appears on these molecule pages

Abiraterone API Testosterone API Testosterone Cypionate API Testosterone Undecanoate API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Hubei Zhuxi Humanwell Pharmaceutical

Does Hubei Zhuxi Humanwell Pharmaceutical hold a US DMF or a CEP?
Hubei Zhuxi Humanwell Pharmaceutical holds 4 active US drug master files. 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 Hubei Zhuxi Humanwell Pharmaceutical FDA-registered?
One site operated by Hubei Zhuxi Humanwell 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 Hubei Zhuxi Humanwell Pharmaceutical's last inspection go?
The most recent inspection on record closed on 1 December 2023 as NAI (No Action Indicated: nothing objectionable was found). 1 inspection is on file.
Where does Hubei Zhuxi Humanwell Pharmaceutical 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 Hubei Zhuxi Humanwell Pharmaceutical make?
4 molecules are on record against Hubei Zhuxi Humanwell Pharmaceutical, including Abiraterone, Testosterone, Testosterone Cypionate and Testosterone Undecanoate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Hubei Zhuxi Humanwell Pharmaceutical's GMP?
Current GMP certificates are on record from 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 NAI, on 1 December 2023.

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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