Suppliers / High Tech Pharm

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.

0
active US DMFs
0
valid CEPs
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
Plants
2 of 2 confirmed
Inspections
5 of 5 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

  • 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

Ertapenem API Imipenem API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1
EMA None 1

Questions about High Tech Pharm

Is High Tech Pharm FDA-registered?
2 sites operated by High Tech Pharm carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did High Tech Pharm's last inspection go?
The most recent inspection on record closed on 13 October 2023 as NAI (No Action Indicated: nothing objectionable was found). 5 inspections are on file.
Where does High Tech Pharm manufacture?
3 registered sites are on record, in South Korea (Chungju and South among others). Every site is listed on this page with the register it came from.
What does High Tech Pharm make?
2 molecules are on record against High Tech Pharm, including Ertapenem and Imipenem. Each links through to that molecule's full manufacturer list.
Which regulators recognise High Tech Pharm's GMP?
Current GMP certificates are on record from US FDA and EMA. 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 NAI, on 13 October 2023.

Comparable suppliers

Acs Dobfar shares 2 molecules Shandong Anhong Pharmaceutical shares 2 molecules Savior Lifetec shares 2 molecules Jilin Asymchem Pharmaceuticals shares 2 molecules Apitoria Pharma shares 1 molecule

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