Suppliers / Samyang Biopharm

Samyang Biopharm

South Korea 98 employees Updated 9 July 2026

Samyang Biopharm is an API manufacturer based in South Korea. It holds one valid CEP. Its GMP standing is certified by EMA.

0
active US DMFs
1
valid CEPs
2
registered plants
0
filings across 0 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
Seongnam-Si, South Korea Not on file
Daedeok, South Korea Not on file

What they file, and where

Molecule Regulators Docs
Paclitaxel EDQM 1

Also appears on these molecule pages

Paclitaxel API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 1

Questions about Samyang Biopharm

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