New Drug CDMOModify Date : 2018-11-17 23:41:25

▣ New Drug CDMO Study

ST Pharm has focused on nucleoside antiviral drugs since the development of zidovudine, a nucleoside AIDS treatment in 1987. As a result, we have been continuously supplying Zidovudine and its intermediate, Cymidine, to GSK, a global pharmaceutical company, and have developed into a global nucleoside-based raw material company by supplying another AIDS drug intermediate to BMS. In recent years, we have achieved a great deal of supply of nucleoside hepatitis C drugs.

ST Pharm has worked together with global big pharma and promising bioventure companies from the early stages of new drug development to produce excellent results through many experiences in production process development and scale-up research. We have been supplying stable raw materials in the long term.

All APIs and intermediates are produced in compliance with cGMP regulations. They are inspected by leading international organizations such as the United States, Europe, Japan, Australia, and the World Health Organization. They are cGMP certified to produce and supply high quality products in international production systems. Doing.

Process, Optimization, Analytical Methods, Documentation, Qualification & Validation

Phase I, Phase II, Phase III

In-Vivo, Pre-Clinical, Clintical Use, Marketed,

Lab Scale, Pilot Scale, Commercial Scale,

Phase Appropriate cGMP Services

Close Communication & Continuous Improvements

ST Pharm's CDMO R & D aims to grow together as a strong partner in our client's new drug development program. Based on the experience of developing various compounds in various clinical stages over the past decades, we provide new drug process solutions in various fields such as development of synthetic processes, method development of intermediates and APIs, process validation (PV), method validation (AMV), and clinical sample production. I will.

We provide the best solutions to our customers based on flexible, mutual cooperation and transparent operation.

New chemical entity, small molecule API

 In addition, we study the process development of various chemicals in the early stages of development.

-We aim for the optimal process development services that our customers need.

With cGMP API production facilities approved by US FDA and EMA

 We produce high quality APIs based on seamless communication and integrated production facilities.