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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

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Sophia Jan
詹富蕙
President and General Manager

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.

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Andy Liu
劉逸辰
Deputy General Manager, Diagnostic Manufacturing Business Division

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

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Carol Lin
林心郁
Assistant Manager, Diagnostic Manufacturing Business Division

National Taiwan University, Department of Veterinary Medicine
Institute of Veterinary Clinical Science National Taiwan University

Experiences:
Associate Researcher, Development Center for Biotechnology

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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

2005
2006
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022

2005

Pharmigene, Inc. was founded.

2006

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).

 

2008

Pharmigene’s HLA-B*1502 Assessment Test received an IVD license from the Department of Health, Taiwan.

 

2009

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.

 

 

2010

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.

 

2011

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.

 

2012

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)

2013

Pharmigene’s HLA-B27 Detection kit received TFDA approval.

2014

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.

2015

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.

2016

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.

2017

Pharmigene(Taipei) obtained GMP certification.
Pharmigene’s HLA-B*1502 has been approved by HAS in Singapore.
Pharmigene (Taipei) obtained ISO 13485/9001.

 

2018

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)

2019

Pharmigene’s HLA-B*5801 was approved by HAS in Singapore.
ISO13485:2016 annual inspection was completed.

 

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.

2021

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.

 

 

2022

Pharmigene received accreditation from TFDA for LDTs laboratory registration (Registration Number LDT00100) and ISO/IEC17025 testing laboratory.

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

Are you ready to join us?

The health of human beings is our responsibility that we never slacken.
人類的健康,是我們永不懈怠的責任。

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