Milestones

Milestones

 

Year Description
April 2021 ScinoPharm Injectable Plant received the first GMP inspection by Taiwan Food and Drug Administration(TFDA)
September 2020 SciAnda (Changshu) Pharmaceutical Ltd. had its first China National Medical Products Administration (NMPA) on-site inspection of drug registration and GMP compliance inspection.
December 2019 Developed by ScinoPharm and sold by Baxter, an injectable formulation of adjuvant antiemetic drugs for chemotherapy patients was launched.
May 2019 Passed the seventh U.S. FDA site inspection in Taiwan
October 2018 The first injectable oncology product was launched in the U.S. market which was the result of our joint venture with SAGENT Pharmaceuticals.
May 2018 SciAnda (Changshu) Pharmaceutical Ltd. passed the first Japanese PMDA site inspections
September 2017 Passed the second Japan Pharmaceuticals and Medical Devices Agency (PMDA) site inspection in Taiwan
February 2017 Passed the sixth U.S. FDA site inspection in Taiwan
October 2016 Passed the first European Directorate for the Quality of Medicine & HealthCare (EDQM) site inspection in Taiwan
October 2015 SciAnda (Changshu) Pharmaceutical Ltd. passed U.S. FDA inspection
March 2015 Passed the fifth U.S. FDA site inspection in Taiwan
August 2014 SciAnda (Changshu) Pharmaceutical Ltd. passed Mexican healthy authority (COFEPRIS) inspection
December 2013 Official inauguration of SciAnda (Changshu) Pharmaceutical Ltd. facility after Phase II construction was completed
August 2013 Passed the first European Medicine Agency (EMA) site inspection in Taiwan
July 2013 Groundbreaking ceremony for new sterile injectable plant facility, constructed as part of ScinoPharm's vertical integration strategy.
December 2012 43 DMFs were registered with the FDA in the United States, and a total of 631 DMFs were registered worldwide
November 2012 Selected as one of the constituent stocks of the Morgan Stanley Capital International (MSCI) Taiwan Index, the first biotech company in Taiwan elected
August 2012 passed the fourth U.S. FDA plant inspection
September 2011 Publicly listed on the Taiwan Stock Exchange Corporation (TWSE), stock code 1789
November 2010 Became the first biotechnology pharmaceutical company to be certified as an Authorized Economic Operator (AEO) by the Taiwan Ministry of Finance
October 2010 Listed as an Emerging Stock on the Taipei Exchange, stock code 1789
August 2010 Signed an investment cooperation pact with Tanvex Biologics, a US company, and Ruentex Group, to jointly develop Biosimilars
August 2009 Investment and establishment of SciAnda (Changshu) Pharmaceutical Ltd.
December 2008 Revenue surpassed USD 100 million
December 2008 New and lagger quality control building commenced operations
October 2008 passed third U.S. FDA plant inspection
September 2008 passed Korean FDA (KFDA) plant inspection
June 2008 passed Japan Pharmaceuticals and Medical Devices Agency (PMDA) plant inspection
June 2008 passed the plant inspection conducted by Hungarian (NIP), an EU member state
October 2007 passed Australian TGA plant inspection
May 2007 Expansion of production line was completed, including Kilo II and ESP II
August 2005 passed second U.S. FDA plant inspection
November 2002 Inauguration of main manufacturing building on Taiwan site
October 2001 passed first U.S. FDA plant inspection
June 2001 Small manufacturing plant (SMU) begins operations
May 2001 Our customer submitted to the abbreviated new drug application (ANDA) for generic drugs to U.S. FDA, being the first one to use the company's active pharmaceutical ingredient (API) Establishment of the reinvested ScinoPharm Biotech Ltd.
February 2001 Establishment of the reinvested ScinoPharm (Kunshan) Biotech Ltd.
January 2001 The first Drug Master File (Drug Master File, DMF) submitted to FDA
November 2000 Mini Plant begins operations
May 2000 Pilot Plant begins operations
March 2000 The first batch of Good Manufacturing Practices (Good Manufacturing Practices, GMP) products delivered to clients
January 2000 Kilo Lab begins operations
October 1999 relocated into the laboratories and offices in Southern Taiwan Science Park
May 1998 Groundbreaking ceremony held at the current site of Southern Taiwan Science Park
May 1998 The US Food and Drug Administration (FDA) screened the company's plant layout design and validation plan
November 1997 ScinoPharm Taiwan, Ltd. established