Company

Milestones

2016

Pharmigene obtained Korea GMP certification.

 

2015

Pharmigene's HLA-B*1502、HLA-B*5801 Detection Kit got CFDA approval.

 

2014

ISO / CE IVD 2014 annual inspection was completed.
CFDA held a professional reviwer meeting for HLA-B*1502 & HLA-B*5801 technical reviews.
Pharmigene partners with Bio-Check laboratories Ltd. to expand Taiwan market.
Pharmigene got ISO approval to expand the capability of the following activities " Design and manufacture of gene detection kit and ELISA kit for clinical use".


2013

Pharmigene's molecular medical lab got ISO 17025 certificate from TAF.
New RUO products for detecting CYP2C19*2 and CYP2C19*3 were developed.
New RUO products for UGT1A1*28 and UGT1A1*60 were launched.
Pharmigene's HLA-B27 Detection Kit got TFDA approval.
ISO / CE IVD 2013 annual inspection was completed.
Pharmigene filed HLA-B* 1502 / 5801 registration with CFDA and got CFDA acceptance letter.


2012

New manufacturing plant was built, and the headquarter relocated to new office in Taipei (Neihu).
GMP inspection for facility and new products was completed.
ISO / CE IVD 2012 annual inspection was completed.
Pharmigene's HLA-B*5801 FastGel Kit got TFDA approval.
Clinical trials of HLA-B* 1502 / 5801 test were launched in mainland China.


2011

Launched two IVD products for detection of HLA-B*5701 and HLA-A*3101.
Pharmigene obtained grant for innovative marketing development from Ministry of Economic Affairs.
Pharmigen's Warfarin Dosage Prediction kit has approved by HAS in Singapore.
ISO / CE IVD 2011 annual inspection was completed.
Pharmigene's HLA-B*5801 Detection Kit got TFDA approval.


2010

Pharmigene partners with Hai Kang Life Corp. to enter Hong Kong market.
Pharmigene received patent "Risk Assessment for Adverse Drug Reactions" issued in Australia.
Pharmigene's HLA-B*1502 Assessment Test and Warfarin sensitivity kits received approval from Department of Health, Taiwan.
Pharmigene Secures Patents Related to Genetic-Based Methods to Fight SJS and TENS in the key global regions.more
Pharmigene supports Mayo Medical Laboratories in United States.more


2009

Pharmigene obtained GMP certification.
Pharmigene received CE Marking for HLA-B*1502 Assessment Test and HLA-B*5801 Assessment Test.
Pharmigene partners with BioPro Pharmaceutical to enter China market.
Pharmigene received patent "Risk Assessment for Adverse Drug Reactions" issued in Singapore.


2008

Pharmigene received patents "Risk Assessment for Adverse Drug Reactions" issued in USA and Taiwan.
Pharmigene completed manufacturing facility construction.
Pharmigene's HLA-B*1502 Assessment Test received approval from Department of Health, Taiwan.
Pharmigene's HLA-B*1502 Assessment Test was selected as the key screening test for a clinical prospective study that involved 27 hospitals and 4500 patients.


2007

FDA approved updated labeling to include pharmacogenomics information pertaining to Coumadin® (warfarin). Pharmigene has the rights to the specifically described genetic marker: vitamin K epoxide reductase (VKORC1) through Academia Sinica.
FDA announced updated labeling to include the association of HLA-B*1502 to Tegretol® (carbamazepine) induced Stevens-Johnson syndrome and toxic epidermal necrolysis.


2006

Pharmigene licensed exclusive world-wide rights to key technologies from Academia Sinica, Taiwan.
Pharmigene obtained ISO 13485/9001.


2005

Founded Pharmigene, Inc.