Suppliers / Samchundang Pharm

Samchundang Pharm

South Korea 3 duplicate records merged Updated 9 July 2026

Samchundang Pharm is a finished-dose manufacturer based in South Korea. It appears in 12 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), MINSA (CR) and EFDA (ET). Its GMP standing is certified by EMA.

0
active US DMFs
0
valid CEPs
1
registered plants
12
filings across 3 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
Hwaseong, South Korea Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 8 None
MINSA (CR) 3 None
EFDA (ET) 1 None
EMA None 2

Questions about Samchundang Pharm

Does Samchundang Pharm hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Samchundang Pharm. It does have 12 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Samchundang Pharm manufacture?
1 registered site is on record, in South Korea (Hwaseong). Every site is listed on this page with the register it came from.
Which regulators recognise Samchundang Pharm'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