Suppliers / Kyongbo Pharmaceutical

Kyongbo Pharmaceutical

South Korea Updated 9 July 2026

Kyongbo Pharmaceutical is an API and finished-dose manufacturer based in South Korea. It holds one active US drug master file and 3 valid CEPs across a filed portfolio of 6 molecules. Its filings concentrate with DAV (Vietnam) and ARCSA (EC). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 11 November 2025 as VAI.

1
active US DMFs
3
valid CEPs
2
registered plants 1 with an FDA FEI number
77
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 11 November 2025 VAI US FDA
  • 6 December 2019 VAI US FDA
  • 1 December 2017 VAI US FDA
  • 26 February 2016 VAI US FDA
  • 28 June 2011 VAI US FDA

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

Registered plants

Site FDA FEI
Asan-Si, South Korea Not on file
South, South Korea 3003773799

What they file, and where

Molecule Regulators Docs
Cefotaxime EDQM 1
Ceftriaxone EDQM 1
Lenalidomide US FDA 1
Pemetrexed Disodium Hemipentahydrate SFDA (Saudi Arabia) 1
Polmacoxib SFDA (Saudi Arabia) 1
Tiotropium EDQM 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
DAV (Vietnam) 76 None
ARCSA (EC) 1 None
US FDA None 1

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Open risk flags

  • The most recent inspection outcome was VAI, on 11 November 2025.

Sources on this page

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