Suppliers / Daewoong

Daewoong

South Korea reconciled across 9 public records · 5 entities Updated 9 July 2026

Daewoong 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), BPOM (ID) and ARCSA (EC). Its GMP standing is certified by BPOM (ID) and EDQM.

2
active US DMFs
4
valid CEPs
9
registered plants 1 with an FDA FEI number
132
filings across 12 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
Gyeonggi-do, United Arab Emirates Not on file
Cheongju-si, United Arab Emirates Not on file
-, Indonesia Not on file
KAB. PASURUAN, Indonesia Not on file
KAB. BEKASI, Indonesia Not on file
Hwasung-City, South Korea Not on file

3 further sites are on record.

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

Cefuroxime Axetil API Ursodeoxycholic Acid API

Filings and GMP by regulator

Regulator Filings GMP certificates
DAV (Vietnam) 84 None
BPOM (ID) 23 14
ARCSA (EC) 6 None
NMPA (CN) 6 None
MINSA (CR) 4 None
US FDA 2 None
EDQM None 4

Questions about Daewoong

Does Daewoong hold a US DMF or a CEP?
Daewoong holds 2 active US drug master files and 4 valid CEPs. 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 Daewoong FDA-registered?
One site operated by Daewoong 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 Daewoong manufacture?
9 registered sites are on record, in United Arab Emirates, Indonesia and South Korea (Gyeonggi-do, Cheongju-si and - among others). Every site is listed on this page with the register it came from.
What does Daewoong make?
3 molecules are on record against Daewoong, including Ursodeoxycholic Acid, Cefuroxime Axetil and Fexuprazan. Each links through to that molecule's full manufacturer list.
Which regulators recognise Daewoong's GMP?
Current GMP certificates are on record from BPOM (ID) and EDQM. 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