Suppliers / Hanmi Fine Chemical

Hanmi Fine Chemical

South Korea reconciled across 13 public records · 3 entities Updated 9 July 2026

Hanmi Fine Chemical is an API manufacturer based in South Korea. It holds one active US drug master file and 5 valid CEPs across a filed portfolio of 7 molecules. Its filings concentrate with ARCSA (EC), MINSA (CR) and INVIMA (CO). Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 2 August 2024 as VAI.

1
active US DMFs
5
valid CEPs
4
registered plants 1 with an FDA FEI number
15
filings across 5 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.

Inspection history

  • 2 August 2024 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Shihung-City, South Korea Not on file
Siheung-si, South Korea Not on file
HWASEONG, South Korea Not on file
South, South Korea 3009350213

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 Cefotaxime API Ceftazidime API Ceftriaxone API

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 5 None
MINSA (CR) 4 None
INVIMA (CO) 2 None
NMPA (CN) 2 None
NPRA (MY) 2 None
US FDA None 1
EMA None 1

Questions about Hanmi Fine Chemical

Does Hanmi Fine Chemical hold a US DMF or a CEP?
Hanmi Fine Chemical holds 1 active US drug master file and 5 valid CEPs. 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.
Is Hanmi Fine Chemical FDA-registered?
One site operated by Hanmi Fine Chemical 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.
How did Hanmi Fine Chemical's last inspection go?
The most recent inspection on record closed on 2 August 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Hanmi Fine Chemical manufacture?
4 registered sites are on record, in South Korea (Shihung-city, Siheung-si and Hwaseong among others). Every site is listed on this page with the register it came from.
What does Hanmi Fine Chemical make?
7 molecules are on record against Hanmi Fine Chemical, including Cefixime, Cefotaxime Sodium, Ceftazidime and Ceftazidime Pentahydrate With Sodium Carbonate For Injection. Each links through to that molecule's full manufacturer list.
Which regulators recognise Hanmi Fine Chemical's GMP?
Current GMP certificates are on record from US FDA and 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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Open risk flags

  • The most recent inspection outcome was VAI, on 2 August 2024.

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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