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
Siheung-Si, South Korea Not on file
Ansan-Si, South Korea Not on file
South, South Korea 3004161413
South, South Korea 3012007381

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

Adenosine contract manufacturing Betahistine API Gadobutrol API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 2

Questions about ST Pharm

Does ST Pharm hold a US DMF or a CEP?
ST Pharm holds 1 active US drug master file and 1 valid CEP. 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 ST Pharm FDA-registered?
2 sites operated by ST 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 ST Pharm's last inspection go?
The most recent inspection on record closed on 8 November 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does ST Pharm manufacture?
4 registered sites are on record, in South Korea (Siheung-si, Ansan-si and South among others). Every site is listed on this page with the register it came from.
What does ST Pharm make?
2 molecules are on record against ST Pharm, including Gadobutrol and Betahistine Dihydrochloride. Each links through to that molecule's full manufacturer list.
Which regulators recognise ST Pharm's GMP?
Current GMP certificates are on record from 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 8 November 2024.

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Sources on this page

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