Suppliers / ST Pharm

ST Pharm

South Korea 3 duplicate records merged Updated 9 July 2026

ST Pharm is an API manufacturer based in South Korea. It holds one active US drug master file and one valid CEP across a filed portfolio of 2 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 8 November 2024 as VAI.

1
active US DMFs
1
valid CEPs
4
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
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 8 November 2024 VAI US FDA
  • 14 July 2023 VAI US FDA
  • 8 November 2018 VAI US FDA
  • 26 September 2014 VAI US FDA
  • 16 April 2009 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, South Korea Not on file
Siheung-Si, South Korea Not on file
South, South Korea 3012007381
South, South Korea 3004161413

What they file, and where

Molecule Regulators Docs
Gadobutrol EDQM, US FDA 2
Betahistine Dihydrochloride SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Betahistine API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 2

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Open risk flags

  • The most recent inspection outcome was VAI, on 8 November 2024.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates