Suppliers / YS Life Science

YS Life Science

South Korea Updated 9 July 2026

YS Life Science is an API manufacturer based in South Korea. It holds 8 active US drug master files and 2 valid CEPs across a filed portfolio of 9 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 14 February 2025 as NAI.

8
active US DMFs
2
valid CEPs
2
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 14 February 2025 NAI US FDA
  • 14 September 2018 NAI US FDA
  • 15 September 2017 OAI US FDA
  • 11 December 2015 VAI US FDA
  • 25 October 2012 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Hwaseong-si, South Korea Not on file
South, South Korea 3005877120

What they file, and where

Molecule Regulators Docs
Cabergoline EDQM, SFDA (Saudi Arabia) 2
Iloprost SFDA (Saudi Arabia), US FDA 2
Latanoprost EDQM, US FDA 2
Bimatoprost US FDA 1
Latanoprostene Bunod US FDA 1
Lubiprostone US FDA 1
Misoprostol US FDA 1
Travoprost US FDA 1
Treprostinil US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about YS Life Science

Does YS Life Science hold a US DMF or a CEP?
YS Life Science holds 8 active US drug master files and 2 valid CEPs. 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 YS Life Science FDA-registered?
One site operated by YS Life Science carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did YS Life Science's last inspection go?
The most recent inspection on record closed on 14 February 2025 as NAI (No Action Indicated: nothing objectionable was found). 5 inspections are on file, of which 1 closed as OAI.
Where does YS Life Science manufacture?
2 registered sites are on record, in South Korea (Hwaseong-si and South). Every site is listed on this page with the register it came from.
What does YS Life Science make?
9 molecules are on record against YS Life Science, including Cabergoline, Iloprost, Latanoprost and Bimatoprost. Each links through to that molecule's full manufacturer list.
Which regulators recognise YS Life Science'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 NAI, on 14 February 2025.

Sources on this page

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