Suppliers / Hanmi Pharm

Hanmi Pharm

South Korea 492 employees Updated 9 July 2026

The public registers hold a second record for Hanmi Pharm. The fuller profile, with 1 active US DMFs and 5 valid CEPs, is at Hanmi Fine Chemical. Figures on this page cover only this record.

Hanmi Pharm is a finished-dose manufacturer based in South Korea. It appears in 13 regulatory filings across 5 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), INVIMA (CO) and MINSA (CR). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 2 August 2024 as VAI.

0
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
13
filings across 5 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, 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
HWASEONG, South Korea Not on file
South, South Korea 3009350213

Filings and GMP by regulator

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

Questions about Hanmi Pharm

Does Hanmi Pharm hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Hanmi Pharm. It does have 13 filings with 5 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Hanmi Pharm FDA-registered?
One site operated by Hanmi Pharm 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 Pharm'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 Pharm manufacture?
2 registered sites are on record, in South Korea (Hwaseong and South). Every site is listed on this page with the register it came from.
Which regulators recognise Hanmi Pharm's GMP?
Current GMP certificates are on record from US FDA. 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.

Comparable suppliers

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates