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

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 2

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Open risk flags

  • The most recent inspection outcome was VAI, on 28 February 2025.

Sources on this page

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