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Pharma & CDMOKOSDAQ 060590128 approvals36 trials

CTC BIO, INC.

Official website

CTC Bio develops veterinary and human medicines using fermentation and drug-delivery technology, including CTCZYME and a CBD oral film.

As of 2026-10-09, CTC BIO, INC. has 4 Korean MFDS device approvals, 124 Korean MFDS drug approvals, 9 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

Price

Change

Market cap

Business overview

Source: DART corporate disclosure

Founded in 1995, CTC Bio listed on KOSDAQ in 2002 as a company spanning veterinary and human pharmaceuticals. Using fermentation and drug delivery system (DDS) technology, it developed CTCZYME, winner of a World Class Product award and the Jang Yeong-sil Award, along with oral dissolving films (ODF) and combination drugs; its animal-health division supplies feed additives, disinfectants, and vaccines, while its human-health division offers improved new drugs, generics, and health functional foods. It commercialized 'Vectorphage A', a bacteriophage-based product to control bacterial disease at olive flounder farms (7/5 domestic patent applications/registrations, 15 strain deposits), and developed a high-dose, high-bioavailability CBD oral dissolving film versus Epidiolex®, transferring manufacturing technology to German CMO Vektor GmbH and completing pilot-scale batch production.

Products & technology

  • CTCZYME
  • 벡터페이즈 A

Regulatory approvals

data.go.kr

124 Korean MFDS drug approvals · 2006–2024 / 4 Korean MFDS device approvals · 2020–2022

  • MFDS drugCinexin Tab. 240mg2024-11-28
    Drug · OTC · Notification202402823
  • MFDS drugOne-two tab.2024-09-09
    Drug · Prescription · Approval202402179
  • MFDS drugReal GLUTATHIONE Orodispersible Film 100mgRevoked2024-08-28
    Drug · OTC · Approval202402079
  • MFDS drugENUF Orodispersible Film 100mg2024-06-19
    Drug · Prescription · Approval202401479
  • MFDS drugOne-two tab.2024-05-16
    Drug · Prescription · Approval202401189
  • MFDS drugCT On Tab. 30mg2024-02-29
    Drug · Prescription · Approval202400422
  • MFDS drugCTCBIO Gluthathione orodispersible film 105mgRevoked2024-02-16
    Drug · OTC · Approval202400342
  • MFDS drugDuyzen Tab. 60/5mg(Fimasartan Potassium Trihydrate/S-Amlodipine besylate)Revoked2023-01-06
    Drug · Prescription · Approval202300104
  • MFDS drugDuyzen Tab. 60/2.5mg(Fimasartan Potassium Trihydrate/S-Amlodipine besylate)Revoked2023-01-06
    Drug · Prescription · Approval202300121
  • MFDS drugDuyzen Tab. 30/2.5mg(Fimasartan Potassium Trihydrate/S-Amlodipine besylate)Revoked2023-01-06
    Drug · Prescription · Approval202300137
  • MFDSSubsidiary: ㈜씨티씨백IVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2022-10-11
    Product approval · Class 3체외 제허 22-678 호
  • MFDSTool for specimensRevoked2022-05-26
    Product approval · Class 1수신 22-929 호
Show 68 more
  • MFDSTool for specimensRevoked2022-04-13
    Product approval · Class 1제신 22-492 호
  • MFDS drugEsoriumPlus Tab. 20/800mg2021-06-14
    Drug · Prescription · Approval202104524
  • MFDS drugNicobreak Orodispersible Film 1mg (Varenicline salicylate)Revoked2021-04-13
    Drug · Prescription · Approval202103088
  • MFDS drugNicobreak Orodispersible Film 0.5mg (Varenicline salicylate)Revoked2021-04-13
    Drug · Prescription · Approval202103089
  • MFDS drugArotinplus tablet 10/40mg(Ezetimibe/Atorvastatin calcium trihydrate)2021-02-18
    Drug · Prescription · Approval202101484
  • MFDS drugArotinplus tablet 10/20mg(Ezetimibe/Atorvastatin calcium trihydrate)2021-02-18
    Drug · Prescription · Approval202101485
  • MFDS drugArotinplus tablet 10/10mg(Ezetimibe/Atorvastatin calcium trihydrate)2021-02-18
    Drug · Prescription · Approval202101486
  • MFDS drugAllerno Orodispersible Film(Loratadine)Revoked2020-08-28
    Drug · OTC · Notification202006062
  • 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), immunological methodRevoked2020-05-21
    Product approval · Class 3체외 제허 20-384 호
  • MFDS drugSaporelly SR Tab. 300mg2020-05-21
    Drug · Prescription · Approval202003676
  • MFDS drugPregaba Cap. 25mg2020-05-19
    Drug · Prescription · Approval202003631
  • MFDS drugPregaba Cap. 50mg2020-05-19
    Drug · Prescription · Approval202003632
  • MFDS drugSaporelly Tab. 100mg2020-05-13
    Drug · Prescription · Approval202003458
  • MFDS drugC-chroquine Tab. 400mg (for export)2020-05-12
    Drug · Prescription · Approval202003433
  • MFDS drugC-chroquine Tab. 200mg (for export)2020-05-12
    Drug · Prescription · Approval202003434
  • MFDS drugC-chroquine Tab. 100mg (for export)2020-05-12
    Drug · Prescription · Approval202003435
  • MFDS drugTrabit Semi SR Tab.2020-05-08
    Drug · Prescription · Approval202003336
  • MFDS drugTrabit SR Tab.2020-05-08
    Drug · Prescription · Approval202003337
  • MFDS drugEcetal SR Tab.2020-04-29
    Drug · Prescription · Approval202003194
  • MFDS drugRemecept Tab. 10mg2020-03-24
    Drug · Prescription · Approval202002049
  • MFDS drugRemecept Tab. 5mg2020-03-24
    Drug · Prescription · Approval202002058
  • MFDS drugTiciren Tab.Revoked2019-12-31
    Drug · Prescription · Notification201908717
  • MFDS drugEasy Flu Powder 30mg2019-10-28
    Drug · Prescription · Approval201907513
  • MFDS drugEasy Flu Powder 45mg2019-10-28
    Drug · Prescription · Approval201907514
  • MFDS drugEasy Flu Powder 75mg2019-10-28
    Drug · Prescription · Approval201907515
  • MFDS drugCelcoxbrex Cap. 200mg2019-09-11
    Drug · Prescription · Approval201906422
  • MFDS drugCave-CT Tab. 25mg2019-08-07
    Drug · Prescription · Approval201905581
  • MFDS drugCave-CT Tab. 12.5mg2019-08-07
    Drug · Prescription · Approval201905582
  • MFDS drugGODN Tab. 10mg2019-05-21
    Drug · Prescription · Approval201903302
  • MFDS drugGODN Tab. 20mg2019-05-21
    Drug · Prescription · Approval201903303
  • MFDS drugJinnetil Tab. 250mg2019-04-17
    Drug · Prescription · Approval201902352
  • MFDS drugMomeCT Nasal Spray Solution2019-03-04
    Drug · Prescription · Notification201901320
  • MFDS drugNose Quick Orodispersible FilmRevoked2018-12-07
    Drug · OTC · Notification201804948
  • MFDS drugMoktein Cap.Revoked2018-11-08
    Drug · OTC · Notification201804440
  • MFDS drugThioctason Tab.Revoked2018-10-31
    Drug · Prescription · Approval201804313
  • MFDS drugClorac Tab.2018-08-21
    Drug · Prescription · Approval201803418
  • MFDS drugNicobreak Tab. 0.5mg2018-08-14
    Drug · Prescription · Approval201803328
  • MFDS drugNicobreak Tab. 1mg2018-08-14
    Drug · Prescription · Approval201803337
  • MFDS drugC-tos Tab.2018-06-27
    Drug · Prescription · Approval201802670
  • MFDS drugCT ryl Tab.2018-05-21
    Drug · Prescription · Approval201802132
  • MFDS drugCTcin Tab.2018-04-30
    Drug · Prescription · Approval201801841
  • MFDS drugCT Gaba Cap. 100mg2018-04-30
    Drug · Prescription · Approval201801845
  • MFDS drugCT Gaba Cap. 300mg2018-04-30
    Drug · Prescription · Approval201801846
  • MFDS drugTaliad Tab.2018-02-28
    Drug · Prescription · Approval201800999
  • MFDS drugMucomipide Tab.2017-07-20
    Drug · Prescription · Approval201705772
  • MFDS drugBabrone Tab. 10mg2017-07-20
    Drug · Prescription · Approval201705785
  • MFDS drugBabrone Tab. 5mg2017-07-20
    Drug · Prescription · Approval201705786
  • MFDS drugMonteloss Tab. 10mg2017-07-20
    Drug · Prescription · Approval201705792
  • MFDS drugMonteros Chewable Tab. 5mg2017-06-30
    Drug · Prescription · Approval201705154
  • MFDS drugMonteros Chewable Tab. 4mg2017-06-30
    Drug · Prescription · Approval201705155
  • MFDS drugPregaba Cap. 150mg2017-05-29
    Drug · Prescription · Approval201702684
  • MFDS drugPregaba Cap. 75mg2017-05-29
    Drug · Prescription · Approval201702685
  • MFDS drugEasy Flu Cap. 75mg2017-05-26
    Drug · Prescription · Approval201702618
  • MFDS drugSafrep Sol.2016-10-06
    Drug · Prescription · Approval201605940
  • MFDS drugDualsartan Tab. 40/10mg2016-09-30
    Drug · Prescription · Approval201605742
  • MFDS drugDualsartan Tab. 40/5mg2016-09-30
    Drug · Prescription · Approval201605743
  • MFDS drugDualsartan Tab. 80/5mg2016-09-30
    Drug · Prescription · Approval201605744
  • MFDS drugLiconazole Tab.2016-06-24
    Drug · Prescription · Approval201603868
  • MFDS drugAldmac Plus D Tab.2016-06-23
    Drug · Prescription · Approval201603802
  • MFDS drugRaprazole Tab. 20mg2016-06-23
    Drug · Prescription · Approval201603803
  • MFDS drugRaprazole Tab. 10mg2016-06-23
    Drug · Prescription · Approval201603804
  • MFDS drugUrodart Soft Cap. 0.5mg2016-06-21
    Drug · Prescription · Approval201603673
  • MFDS drugAd-S Tab.2016-06-21
    Drug · Prescription · Approval201603676
  • MFDS drugRexamel Tab. 20mg2016-06-21
    Drug · Prescription · Approval201603695
  • MFDS drugRexamel Tab. 10mg2016-06-21
    Drug · Prescription · Approval201603696
  • MFDS drugAmorex Tab. 375mg2016-06-20
    Drug · Prescription · Approval201603597
  • MFDS drugAmorex Tab. 625mg2016-06-20
    Drug · Prescription · Approval201603598
  • MFDS drugUraid Tab.2016-06-20
    Drug · Prescription · Approval201603616

Showing the 80 most recent of 128 records.

Clinical trials

data.go.kr

36 MFDS clinical trial authorisations · 2012–2023 (Bioequivalence 20 · Phase 1 13 · Phase 3 2 · Phase 2 1)

  • Bioequivalence씨티씨니세르골린정30mg(가칭)(니세르골린)2023-05-15

    2 trial sites

  • Bioequivalence듀얼살탄정80/5밀리그램(텔미사르탄, 암로디핀)2021-12-31

    2 trial sites

  • Bioequivalence몬테로스정10mg(몬테루카스트나트륨)2021-10-18

    2 trial sites

  • Bioequivalence고든정20mg(타다라필)2021-08-06

    2 trial sites

  • Bioequivalence라프라졸정20mg2021-08-02

    1 trial site

  • Bioequivalence아로틴정20mg(아토르바스타틴칼슘삼수화물)2020-12-01

    2 trial sites

  • BioequivalenceCDFG05182020-07-24

    2 trial sites

  • BioequivalenceCDFF0218(가칭)2020-07-01

    1 trial site

  • Bioequivalence고든정20mg(타다라필)2019-11-06

    1 trial site

  • Bioequivalence클로첸스정(클로피도그렐황산염)2019-09-23

    2 trial sites

  • Phase 1CDFF03182019-03-11

    1 trial site

  • Phase 3CDFR08122019-03-05

    22 trial sites

Show 24 more
  • BioequivalenceCDFF0817(가칭)2019-02-27

    2 trial sites

  • BioequivalenceCDFF0717(가칭)2018-11-27

    2 trial sites

  • BioequivalenceCDFF0712 (가칭)2018-11-27

    2 trial sites

  • BioequivalenceCDFR03172018-11-27

    2 trial sites

  • Bioequivalence로바이드정20mg(로수바스타틴칼슘)2018-06-07

    2 trial sites

  • Bioequivalence메디솔론정(메틸프레드니솔론)2018-01-24

    3 trial sites

  • Phase 1CDFR02162017-05-15

    1 trial site

  • BioequivalenceCDFF0113(가칭)2016-11-25

    2 trial sites

  • Phase 2CDFR08122015-04-15

    16 trial sites

  • BioequivalenceCDFR01142014-10-24

    2 trial sites

  • Phase 1CDFF05112014-07-23

    1 trial site

  • Phase 1CDFF05112014-07-01

    1 trial site

  • BioequivalenceCTC둘록세틴캡슐60mg(가칭)(둘록세틴염산염)2014-06-12

    2 trial sites

  • Bioequivalence듀레신구강용해필름0.2mg(데스모프레신아세트산염)2014-06-09

    2 trial sites

  • Phase 3CDFR0613(가칭), CDFR0612(가칭)2014-04-29

    4 trial sites

  • Phase 1CDFR02092013-11-18

    1 trial site

  • Phase 1컨덴시아정15밀리그램(클로미프라민염산염), 비아그라정100밀리그람(구연산실데나필)2013-11-05

    1 trial site

  • Phase 1CDFF02132013-08-01

    1 trial site

  • Phase 1CDFF02132013-07-31

    1 trial site

  • Phase 1CDFF06122013-06-19

    1 trial site

  • Phase 1CDFF06122013-06-18

    1 trial site

  • Phase 1CDFR01112013-05-10

    1 trial site

  • Phase 1CDFF02122013-02-27

    1 trial site

  • Phase 1플리즈구강용해필름50밀리그램(실데나필)2012-08-02

    1 trial site

Global clinical trials

ClinicalTrials.gov · sponsor-matched

R&D and key agreements

Source: DART corporate disclosure

CBD 구강용해필름 · 뇌전증 등(Epidiolex® 대비 고용량 CBD 제형) · 제조기술 이전 및 pilot scale batch 생산 완료 · Participated in Gyeongbuk Hemp Regulation-Free Zone project, established Andong Research Institute (task No. P0016082). Solubilization technology achieved higher CBD content and bioavailability equal to or better than Epidiolex®; manufacturing technology transferred to German CMO Vektor GmbH; 3 patents (solubilization, stability, manufacturing method) filed

호흡기 병원성 제어 박테리오파지 · 호흡기 병원성 제어 · 제품화 연구 진행 중 · Isolated bacteriophages with multiple strain deposits and patents secured

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 181 more patents

AI reads

MAA server logs · IP-verified
81
Times AI engines pulled CTC BIO, INC.'s records

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Measured since Aug 27, 2026 · 5 AI engines · last read Oct 9, 2026

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Companies approved for the same productsPharma & CDMO

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

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.

Boditech Med Inc.2 shared

KOSDAQ-listed point-of-care immunodiagnostics company supplying diagnostic cartridges and the ichroma/AFIAS instrument series.

HUMASIS CO., LTD.2 shared

KOSDAQ-listed IVD company producing COVID-19 and HIV point-of-care diagnostic reagents alongside rubber products and entertainment businesses.

OSANG HEALTHCARE CO.,LTD.2 shared

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

Median Diagnostics Inc.2 shared

Founded in 1999 and listed on KONEX in 2017, Median Diagnostics develops and manufactures immunoassay, molecular, and point-of-care in vitro diagnostic kits for animal diseases.

PCL. Inc2 shared

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

RollingStone Co., Ltd.2 shared

KOSDAQ-listed in-vitro diagnostics company developing the LabChip-based VERI-Q molecular diagnostic device series.

Sugentech, Inc.2 shared

Founded in 2011 and KOSDAQ-listed in 2019, Sugentech develops multiplex immunoblot, point-of-care, and digital healthcare diagnostics.

Access Bio, Inc.2 shared

Founded in 2002 and KOSDAQ-listed in 2013, Access Bio develops rapid diagnostic tests for malaria, COVID-19, and other infectious diseases.

GC Medical Science Corporation2 shared

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

CALTH. Inc2 shared

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

SD BIOSENSOR INC.2 shared

KOSPI-listed in-vitro diagnostics company known for the STANDARD Q antigen/antibody test kits.

Sources and updates

Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
Approvals & clinical trials
Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
Key disclosures
KRX KIND via OpenDART exchange filings — updated daily
Global clinical trials
ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
Financials
DART corporate disclosure filings — annual
Publications
PubMed (US National Library of Medicine) — affiliation-matched, updated daily
Patents
KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
AI reads
Our server logs, IP-verified every 6 hours
AI visibility
Measured 2026-10-01

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