Milestones

Milestones

 

Year Description
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

ScinoPharm Taiwan, Ltd.