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

What they file, and where

Molecule Regulators Docs
Progesterone SFDA (Saudi Arabia), US FDA 3
Budesonide SFDA (Saudi Arabia), US FDA 2
Dutasteride US FDA 2
Finasteride SFDA (Saudi Arabia), US FDA 2
Apalutamide US FDA 1
Clascoterone US FDA 1
Cyproterone SFDA (Saudi Arabia) 1
Desonide US FDA 1
Dienogest US FDA 1
Drospirenone US FDA 1
Show all 19 molecules on file
Eslicarbazepine Acetate US FDA 1
Estradiol US FDA 1
Ganciclovir SFDA (Saudi Arabia) 1
Lasmiditan US FDA 1
Levonorgestrel US FDA 1
Medroxyprogesterone Acetate US FDA 1
Mirabegron US FDA 1
Oxcarbazepine US FDA 1
Valganciclovir US FDA 1

Also appears on these molecule pages

Show 1 more molecule pages

Filings and GMP by regulator

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

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Open risk flags

  • The most recent inspection outcome was OAI, on 7 November 2025.

Sources on this page

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