Company

Certification

 

Pharmigene, Inc.

2016  Pharmigene obtained Korea GMP certification.

2013  Pharmigene's molecular medical lab got ISO 17025 certificate from TAF.

2012  ISO / CE IVD 2012 annual inspection was completed. GMP inspection for facility and new products was completed.

2011  ISO / CE IVD 2011 annual inspection was completed. 
Pharmigene's HLA-B*5801 Detection Kit got TFDA approval.

2010  ISO / CE IVD 2010 annual inspection was completed.

2009  Pharmigene obtained GMP certification. Pharmigene obtained CE Marking of Conformity-IVD。

2008  PG1502 DNA detection kit received approval from TFDA, listed in the Annex II medical device (No.002588).

2007  US FDA listing (ASR)

2006  Pharmigene obtained ISO 13485/9001.