Steenweg op Mol 129 B-2360 Oud-Turnhout, Belgium   +32 14 720275   info@horsten.be
CHINA
BRUSSELS

REFERENCES

Project Introduction

Xi'an Chiho Pharmaceutical Ltd is a GMP-certified privately owned company in Xi'an, Shaanxi, China. The company was looking for cooperation and toll manufacturing opportunities with interested Western pharmaceutical companies.

The experienced pharmaceutical staff of Horsten assisted the Chinese company to upgrade the quality standard of its facilities and resources to an international level, including assistance in cGMP compliance issues, such as equipment validation, process validation, equipment cleaning procedure validation, analytical method validation, pre-inspections, corrective action plans, etc. As a result the Chinese company passed the UK’s MHRA-inspection. It was one of the very first pharmaceutical companies in China allowed to manufacture and sell finished pharmaceuticals (tablets and capsules) to the European market.

The Chinese company signed an exclusive toll manufacturing agreement with a famous generics company from the United Kingdom.    

Website
www.chiho.com.cn

Involvement of Horsten International

Horsten’s staff assisted the Chinese customer in cGMP compliance issues, such as equipment validation, process validation, equipment cleaning procedure validation, analytical method validation, pre-inspections, corrective action plans, staff etc. At the same time Horsten trained the Chinese staff about European standards and systems.

Horsten also identified and negotiated with European pharmaceutical companies interested in signing a toll manufacturing agreement with the Chinese manufacturer.