Suppliers / Daewoong Bio

Daewoong Bio

South Korea Updated 9 July 2026

Daewoong Bio is an API manufacturer based in South Korea. It holds 2 active US drug master files and 4 valid CEPs across a filed portfolio of 3 molecules. Its filings concentrate with DAV (Vietnam) and MINSA (CR).

2
active US DMFs
4
valid CEPs
3
registered plants 1 with an FDA FEI number
16
filings across 2 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
Hwaseong-Si, South Korea Not on file
Hwasung-City, South Korea Not on file
South, South Korea 3011083160

What they file, and where

Molecule Regulators Docs
Ursodeoxycholic Acid EDQM, US FDA 5
Cefuroxime Axetil EDQM 1
Fexuprazan SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
DAV (Vietnam) 15 None
MINSA (CR) 1 None

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability