Suppliers / Hanmi Fine Chemical

Hanmi Fine Chemical

South Korea 2 duplicate records merged Updated 9 July 2026

Hanmi Fine Chemical is an API manufacturer based in South Korea. It holds 5 valid CEPs across a filed portfolio of 7 molecules. Its GMP standing is certified by EMA.

0
active US DMFs
5
valid CEPs
2
registered plants
2
filings across 1 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
Siheung-si, South Korea Not on file
Shihung-City, South Korea Not on file

What they file, and where

Molecule Regulators Docs
Cefixime EDQM 1
Cefotaxime Sodium EDQM 1
Ceftazidime EDQM 1
Ceftazidime Pentahydrate With Sodium Carbonate For Injection EDQM 1
Ceftriaxone SFDA (Saudi Arabia) 1
Ceftriaxone Sodium EDQM 1
Clopidogrel Napadisilate SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Amlodipine contract manufacturing Atorvastatin contract manufacturing Cefixime API Ceftriaxone API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 2 None
EMA None 1

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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