Suppliers / Yichang Humanwell Pharmaceutical

Yichang Humanwell Pharmaceutical

China 121 employees 2 duplicate records merged Updated 9 July 2026

Yichang Humanwell Pharmaceutical is an API and finished-dose manufacturer based in China. It holds one active US drug master file across a filed portfolio of 2 molecules. Its filings concentrate with US FDA, DAV (Vietnam) and ARCSA (EC). Its GMP standing is certified by MFDS (Korea), TMDA (TZ) and ANVISA (Brazil).

1
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
30
filings across 6 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026.

Registered plants

Site FDA FEI
YICHANG, China Not on file
China, China 3004250049
Hubei, Tanzania Not on file

What they file, and where

Molecule Regulators Docs
Remifentanil SFDA (Saudi Arabia), US FDA 2
Hydromorphone SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 22 None
DAV (Vietnam) 3 None
ARCSA (EC) 2 None
EFDA (ET) 1 None
Health Canada 1 None
MINSA (CR) 1 None
MFDS (Korea) None 2
TMDA (TZ) None 1
ANVISA (Brazil) None 1

Questions about Yichang Humanwell Pharmaceutical

Does Yichang Humanwell Pharmaceutical hold a US DMF or a CEP?
Yichang Humanwell 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 Yichang Humanwell Pharmaceutical FDA-registered?
One site operated by Yichang 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.
Where does Yichang Humanwell Pharmaceutical manufacture?
3 registered sites are on record, in China and Tanzania (Yichang, China and Hubei). Every site is listed on this page with the register it came from.
What does Yichang Humanwell Pharmaceutical make?
2 molecules are on record against Yichang Humanwell Pharmaceutical, including Remifentanil and Hydromorphone. Each links through to that molecule's full manufacturer list.
Which regulators recognise Yichang Humanwell Pharmaceutical's GMP?
Current GMP certificates are on record from MFDS (Korea), TMDA (TZ) and ANVISA (Brazil). 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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Sources on this page

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