Suppliers / Samyang Holdings

Samyang Holdings

South Korea Updated 9 July 2026

Samyang Holdings is an API manufacturer based in South Korea. It holds one active US drug master file and one valid CEP across a filed portfolio of 2 molecules. Its filings concentrate with NPRA (MY) and ARCSA (EC).

1
active US DMFs
1
valid CEPs
2
registered plants
10
filings across 2 regulators

Registered plants

Site FDA FEI
DAEJEON, South Korea Not on file
Gyeonggi-do, South Korea Not on file

What they file, and where

Molecule Regulators Docs
Docetaxel EDQM 1
Paclitaxel US FDA 1

Also appears on these molecule pages

Paclitaxel API Docetaxel API

Filings and GMP by regulator

Regulator Filings GMP certificates
NPRA (MY) 9 None
ARCSA (EC) 1 None

Questions about Samyang Holdings

Does Samyang Holdings hold a US DMF or a CEP?
Samyang Holdings holds 1 active US drug master file 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 Samyang Holdings manufacture?
2 registered sites are on record, in South Korea (Daejeon and Gyeonggi-do). Every site is listed on this page with the register it came from.
What does Samyang Holdings make?
2 molecules are on record against Samyang Holdings, including Docetaxel and Paclitaxel. Each links through to that molecule's full manufacturer list.
Where does Samyang Holdings file?
Filings are on record with NPRA (MY) and ARCSA (EC), 10 in total.

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