Suppliers / Yunnan Hande Bio-Tech

Yunnan Hande Bio-Tech

China 4 employees Updated 9 July 2026

Yunnan Hande Bio-Tech is an API manufacturer based in China. It holds 3 active US drug master files and one valid CEP. Its GMP standing is certified by EMA.

3
active US DMFs
1
valid CEPs
2
registered plants
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Taiping Town, China Not on file
Kunming, China Not on file

What they file, and where

Molecule Regulators Docs
Paclitaxel EDQM, SFDA (Saudi Arabia), US FDA 5

Also appears on these molecule pages

Paclitaxel API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 1

Questions about Yunnan Hande Bio-Tech

Does Yunnan Hande Bio-Tech hold a US DMF or a CEP?
Yunnan Hande Bio-Tech holds 3 active US drug master files and 1 valid CEP. 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.
Where does Yunnan Hande Bio-Tech manufacture?
2 registered sites are on record, in China (Taiping Town and Kunming). Every site is listed on this page with the register it came from.
What does Yunnan Hande Bio-Tech make?
1 molecule is on record against Yunnan Hande Bio-Tech, including Paclitaxel. Each links through to that molecule's full manufacturer list.
Which regulators recognise Yunnan Hande Bio-Tech's GMP?
Current GMP certificates are on record from EMA. 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