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
South, South Korea 3003773799
Asan-Si, South Korea Not on file

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

Cefaclor finished dose Cefdinir finished dose Cefoperazone finished dose Cefotaxime API Ceftriaxone API Dexibuprofen finished dose Lenalidomide API Pemetrexed Disodium Hemipentahydrate API Tiotropium API Trimebutine finished dose

Filings and GMP by regulator

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

Questions about Kyongbo Pharmaceutical

Does Kyongbo Pharmaceutical hold a US DMF or a CEP?
Kyongbo Pharmaceutical holds 1 active US drug master file and 3 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 Kyongbo Pharmaceutical FDA-registered?
One site operated by Kyongbo Pharmaceutical 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 Kyongbo Pharmaceutical's last inspection go?
The most recent inspection on record closed on 11 November 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Kyongbo Pharmaceutical manufacture?
2 registered sites are on record, in South Korea (South and Asan-si). Every site is listed on this page with the register it came from.
What does Kyongbo Pharmaceutical make?
6 molecules are on record against Kyongbo Pharmaceutical, including Cefotaxime, Ceftriaxone, Lenalidomide and Pemetrexed Disodium Hemipentahydrate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Kyongbo Pharmaceutical'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 11 November 2025.

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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