Suppliers / Shanghai Techwell Biopharmaceutical

Shanghai Techwell Biopharmaceutical

China Updated 9 July 2026

Shanghai Techwell Biopharmaceutical is an API manufacturer based in China. It appears in 1 regulatory filing across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by MFDS (Korea) and EMA.

0
active US DMFs
0
valid CEPs
1
registered plants
1
filings across 1 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
Shanghai, China Not on file

What they file, and where

Molecule Regulators Docs
Micafungin SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Micafungin API

Filings and GMP by regulator

Regulator Filings GMP certificates
INVIMA (CO) 1 None
MFDS (Korea) None 2
EMA None 1

Questions about Shanghai Techwell Biopharmaceutical

Does Shanghai Techwell Biopharmaceutical hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Shanghai Techwell Biopharmaceutical. It does have 1 filing with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Shanghai Techwell Biopharmaceutical manufacture?
1 registered site is on record, in China (Shanghai). Every site is listed on this page with the register it came from.
What does Shanghai Techwell Biopharmaceutical make?
1 molecule is on record against Shanghai Techwell Biopharmaceutical, including Micafungin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Shanghai Techwell Biopharmaceutical's GMP?
Current GMP certificates are on record from MFDS (Korea) and 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