Suppliers / Binex Co.,ltd

Binex Co.,ltd

South Korea 96 employees 2 duplicate records merged Updated 9 July 2026

Binex Co.,ltd is a finished-dose manufacturer based in South Korea. It appears in 75 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by EMA.

0
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
75
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Yeonsu-Gu, South Korea Not on file
South, South Korea 3014475240

Filings and GMP by regulator

Regulator Filings GMP certificates
DAV (Vietnam) 75 None
EMA None 2

Questions about Binex Co.,ltd

Does Binex Co.,ltd hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Binex Co.,ltd. It does have 75 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Binex Co.,ltd FDA-registered?
One site operated by Binex Co.,ltd 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 Binex Co.,ltd manufacture?
2 registered sites are on record, in South Korea (Yeonsu-gu and South). Every site is listed on this page with the register it came from.
Which regulators recognise Binex Co.,ltd'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