Milestones

Milestones

 

Year Description
2017 Passed the sixth U.S. FDA site inspection in Taiwan
2016

Passed the first European Directorate for the Quality of Medicine & HealthCare (EDQM) site inspection in Taiwan

2015

ScinoPharm (Changshu) Pharmaceutical Ltd.passed U.S. FDA inspection

2015

Passed the fifth U.S. FDA site inspection in Taiwan

2014

ScinoPharm (Changshu) Pharmaceutical Ltd.passed Mexican healthy authority(COFEPRIS) inspection

2013

Passed the first European Medicine Agency (EMA) site inspection in Taiwan

2012

Passed the fourth U.S. FDA site inspection in Taiwan Added to Morgan Stanley Capital International Taiwan Index, the first biotech company in Taiwan elected

2011

Successfully completed IPO in Taiwan on September 29 (Traded on the TSEC, Company Code 1789)

2010

Strategic investment in Tanvex Biologics, Inc., a United States company specializing in the development of biosimilars Listed on the Emerging Stock Market in Taiwan

2009

ScinoPharm (Changshu) Pharmaceutical Ltd. Established in China Received Industrial Technology Advancement Award from the Ministry of Economic Affairs

2008

Passed Japanese PMDA, Korean FDA & Hungarian NIP site inspections in Taiwan Passed the third U.S. FDA site inspection in Taiwan

2007

10-year anniversary Passed Australian TGA site inspection in Taiwan

2006

Worldwide customers and DMF registrations exceed 1000

2005

First NCE API supplied for commercial launch in Europe Growing product offerings including Oncology APIs, supplied to customers in Europe and South America Passed the second U.S. FDA site inspection in Taiwan Awarded the 2005 Entrepreneurial Company Award by Frost & Sullivan

2004

First dedicated facility for early clinical material completed

2003

First generic API supplied for commercial launch in the U.S.

2002

Two of the three large-scale production bays validated for cGMP operations

2001

Passed the first U.S. FDA site inspection at Taiwan manufacturing site ScinoPharm Kunshan in China and ScinoPharm Biotech established

2000

cGMP production began in small-scale units

1999

Relocated temporary labs and offices to present site

1998

U.S. GMP plant construction began in the Tainan Science-Based Industrial Park

1997

ScinoPharm Taiwan, Ltd. established