ST Pharm's Global Approval
During past three decades, ST PHARM has grown into a reliable custom manufacturing partner through strong support and close communication with clients around the world.
ST PHARM provides expert cGMP manufacturing services from the development stage to commercial scale using accumulated process know-hows.
- Korean GMP
1992
1992 – 1998
- Gilead
- DMF Type I for Sihwa factory
(US DMF No.10734)
1994
1994
- DMF Type I for Sihwa factory
- DMF Type II for API (US DMF No.13181)
WHO BGMP by KFDA
1998
1998
- DMF Type II for API (US DMF No.13181)
2000
2000 – 2005
- Gilead
2003
- FDA
2006
2006 – 2011
- BMS
Gilead
Roche
- EDQM
WHO
2007
- EDQM
2008
- FDA
2009
- KFDA
2010
- ANVISA
2011
2012
- EDQM / PMDA / TGA / PAI
2013
2013
- Client M
Client B
- FDA / PMDA / PAI
2014
- KFDA
2015
2015
- Client G
- HPRA / WHO
2016
2016
- Client G
Client J
Client M
Client R
- PMDA / KFDA
2017
2017
- Client B
Client J
- FDA / PMDA / KFDA
2018
2018
- Client N
Client R
Client J
Client M
Client Z
2019
- Client N
Client A
- Client N
- US-FDA (PAI)
Pre-Approval Inspection
2021
2021
- Client N
Client G
- US-FDA (PAI)
