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.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Ansan-si, Gyeonggi-do, South Korea | Not on file |
| Ansan, South Korea | Not on file |
| South, South Korea | 3002806679 |
| 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 |
| Tacrolimus | US FDA | 2 |
| Potassium Clavulanate | SFDA (Saudi Arabia) | 1 |
| Teicoplanin | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | None | 2 |
| US FDA | None | 1 |
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