About Us
Pharmigene’s mission is to protect human life from adverse effects and to enhance drug efficacy and safety.
About PharmiGENE
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.
Honorary Founder
Education
M.A., Department of Anthropology, University of Tsukuba, Japan
Current position
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
Experiences：
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
Experiences：
Associate Researcher, Development Center for Biotechnology
15th Anniversary Review and Prospect
Our Products...
Our products are always designed, redesigned, developed, manufactured, and packaged with the highest standards in the industry.
Our Customers...
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
Milestones
2016
世基5801基因檢測套組通過韓國KGMP查驗許可、MFDS第三級IVD產品上市許可
2015
世基1502、5801基因檢測套組獲中國上市許可
世基5801產品通過CFDA技術審評，進入行政審評
2014
世基通過ISO/CE IVD年度定期追查
CFDA召開專家會議，進行HLA-B*1502/5801產品技術審評
世基與保吉生化學股份有限公司攜手，擴展台灣市場
世基B27產品獲得CE認證
世基通過ISO認證，擴大ISO證書驗證範圍，可設計和生產ELISA kit
2013
世基生醫分子醫學實驗室取得ISO17025測試實驗室認證(認證機構: TAF)
新增CYP2C19*2和
2020
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.
| Awards | |
|---|---|
| 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 |
| Certifications | |
|---|---|
| 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. |
News and Events
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.
Channel Partners
Hosp. / Labs
Distributors Information
► China
Guangzhou Cell-one Bioscience Co.，Ltd
Room 405&406, G Building, NO.188 Kaiyuan Avenue,Science City, Luogang District 510000, Guangzhou;
Tel: +86-20-87658152
Fax: +86-20-87658552
Email: cell_one@163.com
► China
Shanghai Size Medical Technology Inc.
Room 909, Building 3, Oriental Blue Ocean International Plaza, NO.1800 Huang Xing Road, Yangpu District,200433, Shanghai;
Tel: +86-21-61373799
Fax: +86-21-61373797
Email: info@gene-size.com
► Singapore
SciMed (Asia) Pte Ltd ((Headquarters)
196 Pandan Loop #07-11 Pantech Business Hub Singapore 128384
Tel: (65) 6779 3388
Fax: (65) 6266 3086
Service Hotline: (65) 6735 1333
Sales & Feedback: sales@scimed.com.sg
Services & Support: services@scimed.com.sg
► Korea
Dow Biomedica
3, 5, 6F, Dow Bldg., 29 Yangsan-ro, Songpa-gu, Seoul, 05771, Korea
Tel: 82-2-2201-3602
Fax: 82-2-2201-2166
E-mail:info@dowbiomedica.co.kr
► Italy
LCM Genect
Via Mazzini , 33 – 20099 Sesto San Giovanni (MI) Italy
Tel: +39 02 2422084
Fax: +39 02 2422084
E-mail: info@lcm-genect.com