Pharmigene’s mission is to protect human life from adverse effects and to enhance drug efficacy and safety.
PharmiGENE was established in 2005 and funded by venture capitalists and angel investors. Our goal is to innovate and commercialize diagnostic tests that enable everyone to be better informed about his/her genetic makeup and to make decisions that can better their health. We have licensed from Academia Sinica the exclusive rights to key technologies relating to genetic markers associated with adverse drug reactions caused by several popular pharmaceutical products. We have obtained ISO 13485 and GMP certifications, and are manufacturing our DNA genetic tests under the most stringent guidelines. We also have validated our DNA genetic tests with clinical studies that involved hundreds and thousands of patients. Today, our DNA genetic tests are available worldwide, receiving IVD clearance from the Ministry of Health and Welfare of Taiwan.
M.A., Department of Anthropology, University of Tsukuba, Japan
President and General Manager, PharmiGENE, Inc.
President, MAAN Group,Inc.
Director, WEI-ER INTERNATIONAL CO., LTD.
Director, Pan-Jade Engineering Consulting CO., Ltd.
Director, GENE HEALTH CO., LTD.
Chang Gung University, Department of Medical Technology
National University, Institute of Forensic Medicine
Research Associate, National Institutes of Health
Marketing Assistant Manager, Everlight Biotech Co Ltd
Business Associate, PharmiGENE
Business Senior Manager, CellMax Life
Business Senior Manager, INVENTEC APPLIANCES CORPORATION
National Taiwan University, Department of Veterinary Medicine
Institute of Veterinary Clinical Science National Taiwan University
Associate Researcher, Development Center for Biotechnology
15th Anniversary Review and Prospect
Our products are always designed, redesigned, developed, manufactured, and packaged with the highest standards in the industry.
Pharmigene places greatest value in customer’s satisfaction. We deliver our products with promised quality as a trustworthy partner. Fast responses to our customers‘ needs and questions is always our top priority.
Our Manufacturing Service...
Partners Manufacturing at Pharmigene is conducted with uncompromising integrity. We strictly protect our partner‘s intellectual property and know-how while doing our best to assist our partners achieving their goals
The Pharmigene Team...
All Pharmigene team members are committed to a high level of achievement and contribution. At Pharmigene, we regard every employee as a prime asset and resource who are able provide reliable and exceptional solutions and services with integrity as the most important of all corporate values.
To Our Shareholders...
We offer our gratitude to all our shareholders, customers, and business partners for their long-term support and encouragement. Pharmigene and its employees will spare no effort to maintain a firm commitment to enhance its corporate governance and social responsibility. Pharmigene will continue to move toward a sustainable development and to seek better corporate value for its shareholders, customers, and employees
Pharmigene, Inc. was founded.
Pharmigene is licensed with exclusive worldwide rights to key technologies from Academia Sinica, Taiwan (Risk Assessment for Adverse Drug Reactions) and entered into a collaboration with the Genomics Research Center at Academia Sinica.
Pharmigene received ISO-13485 certification (Verification Unit: SGS).
Pharmigene’s HLA-B*1502 Assessment Test received an IVD license from the Department of Health, Taiwan.
2008/06 Pharmigene completed manufacturing facility construction. (Xizhi)
2009/01 Pharmigene obtained GMP certification. (Verification Unit: ITRI Measurement Center)
Pharmigene received CE Marking for the HLA-B*1502 Assessment Test and the HLA-B*5801 Assessment Test.
Pharmigene’s HLA-B*1502 Assessment Test and Warfarin sensitivity kits received approval from Department of Health, Taiwan.
A total of 6 products in Pharmigene’s HLA-B*1502/5801 received IVD List B CE Certification (Verification Unit: SGS)
The warfarin 1075 detection panel obtained an IVD license from the Department of Health.
Pharmigene’s HLA-B*1502 detection was integrated into the National Health Insurance Program of Taiwan.
The HLA-B*5801 Detection received an IVD license from the Department of Health, Taiwan.
Pharmigen’s Warfarin Dosage Prediction kit was approved by HAS in Singapore.
PG1502/5801/5701/3101/1639/1075/0430 ASR completed FDA filing.
GMP inspection for the facility and new products was completed.
Pharmigene’s HLA-B*5801 Assessment Test received approval from the Department of Health, Taiwan.
A new manufacturing plant was built, and the headquarter relocated to Taipei (Neihu).
ISO / CE IVD 2012 annual inspection was completed.
Pharmigene’s HLA-B*5701/3101 received IVD List B CE certification (Verification Unit: SGS)
Pharmigene’s HLA-B27 Detection kit received TFDA approval.
Pharmigene (Taipei) received GMP certification and added UniPharma Co., Ltd. DR70 registration item C.6010 (Verified by: ITRI Measurement Center).
Pharmigene obtained ISO approval to expand the capability of the following: Design and manufacture of gene detection kit and ELISA kit for clinical use.
Pharmigenen launched IVD products for the detection of HLA-B27.
Pharmigene assisted UniPharma Co. to obtain an IVD license for DR-70 from the Ministry of Health and Welfare, Taiwan.
Pharmigene’s HLA-B*1502、HLA-B*5801 Detection Kits were approved by CFDA.
Pharmigene’s HLA products abide by the CE Declaration of Conformity.
UniPharma DR-70 received TFDA approval for product validity extension.
Pharmigene obtained Korea GMP certification (Verification Unit: Korea Testing Certificate, KTC).
Pharmigene’s HLA-B*5801 was approved in Korea.
Pharmigene(Taipei) obtained GMP certification.
Pharmigene’s HLA-B*1502 has been approved by HAS in Singapore.
Pharmigene (Taipei) obtained ISO 13485/9001.
Pharmigene’s HLA-B*27/1502/5801/5701 received IVD List B CE certification (Verification Unit: Bsi)
Pharmigene’s ISO13485:2016 conversion certification was approved. (Verification Unit: Bsi)
Pharmigene’s HLA-B*5801 was approved by HAS in Singapore.
ISO13485:2016 annual inspection was completed.
OPharmigene was publicly traded on Taiwan’s OTC stock market.
Pharmigene developed SARS-CoV-2 Antigen Rapid Tests.
LDTs Lab importer Third Generation Sequencing System.
<Genetic Testing for Common Medications in Children> was successfully developed.
Striving for the HLA-B*5801 test to be included in Taiwan’s National Health Insurance.
OEM COVID-19 Antigen Rapid Test.
Chang Gung Medical Foundation completed Technology Transfer <Sulfonamide Antibiotic (BAKTAR) Profile> to Pharmigene.
Collaboration with Taipei Medical University Hospital.
Self-developed SARS-CoV-2 Antigen Test and <Genetic Testing for Common Medications in Children> entered the Taiwan market.
Pharmigene received accreditation from TFDA for LDTs laboratory registration (Registration Number LDT00100) and ISO/IEC17025 testing laboratory.
|2018||Taipei Biotech Awards「Technology Transfer Award」Silver Award|
|2015||2015 The 12th Ｎational Innovation Awards "Enterprise Innovation Award"|
|2010||The first Pharmacogenetic testing which integrated into National Health Insurance in history|
|2009||Taipei Biotech Awards "Technology Transfer Award"-Special Mention Award|
|2008||Taipei Biotech Awards "Innovation Award"-Gold Award|
|2008||Taiwan Healthcare and Agricultural Biotech Industries Innovation and Excellence Awards--Gold Award|
|2008||Business Startup Awards "Technology-niche Industry Group"-Special Mention Award|
|2008||Taiwan Healthcare and Agricultural Biotech Industries Innovation and Excellence Awards--Silver Award|
|2007||Taipei Biotech Awards "industry-university cooperation"-Gold Award|
|2007||Taipei Biotech Awards "Technology Transfer Award"-Silver Award|
|2022||Pharmigene received accreditation from TFDA - LDTs laboratory registration (registration number LDT0010) and ISO/IEC 17025 testing laboratory.|
|2018||Training and validation of "Laboratory Developed Tests and Services, LDTs" accredited by the Food and Drug Administration.|
|2018||Pharmigene(Taipei)obtained conversion certification ISO13485:2016 (Verification Unit: Bsi).|
|2018||"Precision Medical Molecular Testing Laboratory Testing and Services" passed counseling and verification from the TFDA pilot program|
|2018||Pharmigene’s HLA-B*27/1502/5801/5701 received IVD List B CE certification (Verification Unit: Bsi)|
|2016||Pharmigene obtained Korea GMP certification.。|
|2013||Pharmigene's molecular medical lab got ISO 17025 certificate from TAF.|
|2012||Pharmigene（Taipei）obtained IVD List B CE certification.|
|2012||Pharmigene(Taipei)obtained GMP certification.|
|2012||The headquarter relocated to new office in Taipei (Neihu).|
|2012||New manufacturing plant was built.|
|2012||ISO / CE IVD 2012 annual inspection was completed.|
|2012||GMP inspection for facility and new products was completed.|
|2011||ISO / CE IVD 2011 annual inspection was completed.|
|2010||ISO / CE IVD update validation was completed.|
|2009||Pharmigene obtained GMP certification.|
|2009||Pharmigene obtained CE Marking of Conformity-In Vitro Diagnostic Medical Devices.|
|2008||Factory Registration Certificate, Ministry of Economic Affairs (Xizhi Factory: Shiji Dahu Science Park).|
|2008||Pharmigene obtained Pharmacist manufacturing and Pharmacist selling license.|
|2008||Pharmigene's HLA-B*1502 Assessment Test received approval from Department of Health, Taiwan.|
|2007||The product has been registered by the U.S. FDA as a Class I product.|
|2006||Pharmigene obtained ISO 13485.|
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Partnering With Us
Please find the distributor(s) in your country listed below. If Pharmigene currently does not have a distributor in your country, please contact us. Our sales representative will get in touch with you.
If you are interested in being a distributor for Pharmigene, please feel free to contact us.
Hosp. / Labs
Guangzhou Cell-one Bioscience Co.，Ltd
Room 405&406, G Building, NO.188 Kaiyuan Avenue,Science City, Luogang District 510000, Guangzhou;
Shanghai Size Medical Technology Inc.
Room 909, Building 3, Oriental Blue Ocean International Plaza, NO.1800 Huang Xing Road, Yangpu District,200433, Shanghai;