Suppliers / CKD Bio

CKD Bio

South Korea 62 employees Updated 9 July 2026

CKD Bio is an API manufacturer based in South Korea. It holds 28 active US drug master files across a filed portfolio of 13 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 7 November 2025 as VAI.

28
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 7 November 2025 VAI US FDA
  • 15 September 2023 VAI US FDA
  • 18 November 2022 NAI US FDA
  • 26 October 2018 VAI US FDA
  • 17 December 2015 NAI US FDA
  • 8 March 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
Ansan-si, Gyeonggi-do, South Korea Not on file
Ansan, South Korea Not on file
South, South Korea 3002806679

What they file, and where

Molecule Regulators Docs
Clavulanic Acid SFDA (Saudi Arabia), US FDA 7
Rifamycin US FDA 4
Cyclosporine SFDA (Saudi Arabia), US FDA 3
Acarbose US FDA 2
Daptomycin US FDA 2
Demeclocycline US FDA 2
Everolimus US FDA 2
Lactobacillus Acidophilus US FDA 2
Peramivir US FDA 2
Rifampin US FDA 2
Show all 13 molecules on file
Tacrolimus US FDA 2
Potassium Clavulanate SFDA (Saudi Arabia) 1
Teicoplanin SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Acarbose API Ciclosporin API Clavulanic Acid API Cyclosporine API Daptomycin API Everolimus API Potassium Clavulanate API Rifampicin API Rifampin API Rifamycin API Tacrolimus API Teicoplanin API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 2
US FDA None 1

Questions about CKD Bio

Does CKD Bio hold a US DMF or a CEP?
CKD Bio holds 28 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 CKD Bio FDA-registered?
One site operated by CKD Bio 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 CKD Bio's last inspection go?
The most recent inspection on record closed on 7 November 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does CKD Bio manufacture?
3 registered sites are on record, in South Korea (Ansan-si, Gyeonggi-do, Ansan and South). Every site is listed on this page with the register it came from.
What does CKD Bio make?
13 molecules are on record against CKD Bio, including Clavulanic Acid, Rifamycin, Cyclosporine and Acarbose. Each links through to that molecule's full manufacturer list.
Which regulators recognise CKD Bio's GMP?
Current GMP certificates are on record from EMA and 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 7 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