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 II for API (US DMF No.13181)
      WHO BGMP by KFDA

    1998

    1998

  • 2000

    2000 – 2005

    • Gilead
  • 2003

    • FDA

    2006

    2006 – 2011

    • BMS
      Gilead
      Roche
    • EDQM
      WHO

    2007

  • 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
    • US-FDA (PAI)
      Pre-Approval Inspection

    2021

    2021

    • Client N
      Client G
Succesfully Inspected by