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Medical DevicesKOSDAQ 1537108 approvals

Optipharm.CO.,LTD

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Optipharm, founded in 2000 and KOSDAQ-listed in 2018, provides animal disease diagnostics, animal medicine, and biotech.

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Business overview

Source: DART corporate disclosure

Founded in 2000 and listed on KOSDAQ in 2018, Optipharm specializes in animal disease diagnostics, animal medicine, and biotechnology. It operates animal disease diagnostic services using serological, antigen gene (PCR), and histopathological testing, along with molecular diagnostic kits for diseases including African swine fever, porcine reproductive and respiratory syndrome (PRRS), and avian influenza, plus animal medicine distribution, bacteriophage development, the Medipig miniature pig and xenotransplantation business, and VLP vaccine development. It has been designated by the Animal and Plant Quarantine Agency for 84 diseases and 212 test items, transferred a PRRS preventive vaccine strain license in April 2020, and obtained item approval for the swine oral fluid collection kit after registering as an animal medical device manufacturer in August 2019.

Regulatory approvals

data.go.kr

8 Korean MFDS device approvals · 2013–2024

  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2024-09-30
    Product approval · Class 3체외 제허 24-657 호
  • MFDSIVD reagents for cancer related gene2018-03-29
    Product approval · Class 3체외 제허 18-212 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-01-31
    Product approval · Class 3체외 제허 18-56 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2017-05-19
    Product approval · Class 3체외 제허 17-333 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2017-05-19
    Product approval · Class 3체외 제허 17-332 호
  • MFDSIVD reagents for staining or culturing clinical microbiologyRevoked2015-05-19
    Product approval · Class 1대전 체외 제신 15-47 호
  • MFDSIVD reagents for staining or culturing clinical microbiologyRevoked2015-05-19
    Product approval · Class 1대전 체외 제신 15-46 호
  • MFDSIVD reagents for extracting nucleic acids2013-07-08
    Product approval · Class 1대전 체외 제신 13-44 호
Not yet compiled: business overview · products · R&D. Send us materials and we will add them

Companies approved for the same productsMedical Devices

Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.

GC Medical Science Corporation4 shared

GC Medical Science Corporation, KOSDAQ-listed since 2014, operates diagnostic reagent, blood glucose, and hemodialysis solution businesses.

BIONEERCORPORATION3 shared

Bioneer, founded in 1992 and KOSDAQ-listed in 2005, provides gene analysis equipment, molecular diagnostics, and RNAi drug development.

Gencurix Inc.3 shared

Founded 2011, KOSDAQ-listed 2020, Gencurix develops liquid-biopsy diagnostics: breast cancer prognosis and lung/colorectal companion tests.

Genomictree Inc.3 shared

Cancer molecular diagnostics company behind the EarlyTect-C stool-based colorectal cancer test using the SDC2 methylation biomarker.

HLB PANAGENE Co., LTD.3 shared

Founded in 1976 and KOSDAQ-listed in 2000, HLB PANAGENE develops PNA-based molecular diagnostic and diagnostic automation products.

LabGenomics. Co., Ltd.3 shared

KOSDAQ-listed molecular genetic diagnostics company providing NGS-based non-invasive prenatal testing (NIPT) under the MomGuard brand.

SEEGENE, INC.3 shared

Founded in 2000 and KOSDAQ-listed in 2010, Seegene develops syndromic multiplex PCR molecular diagnostic reagents.

CALTH. Inc2 shared

Holds manufacturing approvals for 42 point-of-care diagnostic reagents and devices in the IVD market.

GENOLUTION INC.2 shared

Founded in 2006 and listed on KOSDAQ in 2020, Genolution is a molecular diagnostics and RNAi company producing nucleic acid extraction reagents and devices.

NanoenTek,Inc.2 shared

Founded in 1987 and listed on KOSDAQ in 2000, NanoenTek develops Lab-On-a-Chip in-vitro diagnostic devices and life science instruments.

OSANG HEALTHCARE CO.,LTD.2 shared

Founded 1996, listed on KOSDAQ in 2024, OSANG HEALTHCARE develops and sells biochemistry, immunodiagnostic, and molecular IVD products.

PCL. Inc2 shared

KOSDAQ-listed IVD company using SG Cap™ multiplex diagnostic technology for infectious disease, cancer, and companion animal testing.

Sources and updates

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
AI visibility
Measured 2026-08-13

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