Suppliers / Yuhan Chemical

Yuhan Chemical

South Korea Updated 9 July 2026

Yuhan Chemical is an API manufacturer based in South Korea. It holds 2 active US drug master files across a filed portfolio of 5 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 28 February 2025 as VAI.

2
active US DMFs
0
valid CEPs
2
registered plants 2 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 28 February 2025 VAI US FDA
  • 12 January 2024 VAI US FDA
  • 17 January 2020 VAI US FDA
  • 1 November 2018 NAI US FDA
  • 22 September 2017 VAI US FDA
  • 4 December 2015 VAI US FDA
  • 27 June 2014 NAI US FDA
  • 8 November 2012 VAI US FDA

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

Registered plants

Site FDA FEI
South, South Korea 3008853591
South, South Korea 3004015296

What they file, and where

Molecule Regulators Docs
Emtricitabine SFDA (Saudi Arabia) 1
Piperacillin US FDA 1
Ribavirin US FDA 1
Velpatasvir SFDA (Saudi Arabia) 1
Voxilaprevir SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Emtricitabine API Piperacillin API Ribavirin API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 2

Questions about Yuhan Chemical

Does Yuhan Chemical hold a US DMF or a CEP?
Yuhan Chemical holds 2 active US drug master files. 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 Yuhan Chemical FDA-registered?
2 sites operated by Yuhan Chemical carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Yuhan Chemical's last inspection go?
The most recent inspection on record closed on 28 February 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Yuhan Chemical manufacture?
2 registered sites are on record, in South Korea (South among others). Every site is listed on this page with the register it came from.
What does Yuhan Chemical make?
5 molecules are on record against Yuhan Chemical, including Emtricitabine, Piperacillin, Ribavirin and Velpatasvir. Each links through to that molecule's full manufacturer list.
Which regulators recognise Yuhan Chemical'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 28 February 2025.

Comparable suppliers

Apitoria Pharma shares 3 molecules Hetero shares 1 molecule Cipla shares 1 molecule Matrix Pharmacorp shares 1 molecule Macleods Pharmaceuticals shares 1 molecule

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