Suppliers / Dongkook Pharmaceutical

Dongkook Pharmaceutical

South Korea Updated 9 July 2026

Dongkook Pharmaceutical is a contract manufacturer based in South Korea. It holds one valid CEP. Its filings concentrate with ARCSA (EC), UZPHARM (UZ) and NCELS (KZ). Its GMP standing is certified by ANVISA (Brazil).

0
active US DMFs
1
valid CEPs
2
registered plants
7
filings across 3 regulators

Registered plants

Site FDA FEI
Seoul, South Korea Not on file
JINCHEON-GUN, South Korea Not on file

What they file, and where

Molecule Regulators Docs
Teicoplanin EDQM 1

Also appears on these molecule pages

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Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 4 None
UZPHARM (UZ) 2 None
NCELS (KZ) 1 None
ANVISA (Brazil) None 1

Questions about Dongkook Pharmaceutical

Does Dongkook Pharmaceutical hold a US DMF or a CEP?
Dongkook Pharmaceutical holds 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 Dongkook Pharmaceutical manufacture?
2 registered sites are on record, in South Korea (Seoul and Jincheon-gun). Every site is listed on this page with the register it came from.
What does Dongkook Pharmaceutical make?
1 molecule is on record against Dongkook Pharmaceutical, including Teicoplanin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Dongkook Pharmaceutical's GMP?
Current GMP certificates are on record from 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