High Tech Pharm
South Korea Updated 9 July 2026
High Tech Pharm is an API manufacturer based in South Korea. Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 13 October 2023 as NAI.
3
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
Inspections
5 of 5 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
- 13 October 2023 NAI US FDA
- 11 November 2022 NAI US FDA
- 28 September 2017 VAI US FDA
- 27 March 2015 VAI US FDA
- 21 September 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 |
| Chungju, South Korea | Not on file |
| South, South Korea | 3003663236 |
| South, South Korea | 3015364229 |
What they file, and where
| Molecule | Regulators | Docs |
| Ertapenem | SFDA (Saudi Arabia) | 1 |
| Imipenem | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| US FDA | None | 1 |
| EMA | None | 1 |
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Open risk flags
- The most recent inspection outcome was NAI, on 13 October 2023.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates