Suppliers / Hubei Gedian humanwell Pharmaceutical

Hubei Gedian humanwell Pharmaceutical

China 40 employees Updated 9 July 2026

Hubei Gedian humanwell Pharmaceutical is an API manufacturer based in China. It holds 19 active US drug master files across a filed portfolio of 19 molecules. Its filings concentrate with MINSA (CR) and DAV (Vietnam). Its GMP standing is certified by MFDS (Korea). Its most recent recorded inspection, by US FDA, closed on 7 November 2025 as OAI.

19
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
4
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 7 November 2025 OAI US FDA
  • 28 June 2019 VAI US FDA
  • 13 May 2016 VAI US FDA
  • 17 October 2013 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 3004117486

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 3 None
DAV (Vietnam) 1 None
MFDS (Korea) None 4

Questions about Hubei Gedian humanwell Pharmaceutical

Does Hubei Gedian humanwell Pharmaceutical hold a US DMF or a CEP?
Hubei Gedian humanwell Pharmaceutical holds 19 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 Gedian humanwell Pharmaceutical FDA-registered?
One site operated by Hubei Gedian 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 Gedian humanwell Pharmaceutical's last inspection go?
The most recent inspection on record closed on 7 November 2025 as OAI (Official Action Indicated, the worst classification: objectionable conditions were found and regulatory action was warranted). 4 inspections are on file, of which 1 closed as OAI.
Where does Hubei Gedian 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 Gedian humanwell Pharmaceutical make?
19 molecules are on record against Hubei Gedian humanwell Pharmaceutical, including Progesterone, Budesonide, Dutasteride and Finasteride. Each links through to that molecule's full manufacturer list.
Which regulators recognise Hubei Gedian humanwell Pharmaceutical's GMP?
Current GMP certificates are on record from MFDS (Korea). 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 OAI, on 7 November 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