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Pharma & CDMOKOSPI 002720265 approvals46 trials

Kukje Pharma Co., Ltd.

Official website

Founded in 1959, Kukje Pharma produces prescription and OTC drugs including Cuallon eye drops, Cholencina capsules, and Retium tablets.

Price

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Market cap

Business overview

Source: DART corporate disclosure

Founded in 1959 and listed on KOSPI in 1975, Kukje Pharma is a pharmaceutical company. It produces prescription and OTC drugs including Cuallon eye drops, Cholencina soft capsules, Ezeroba tablets, Identgelt injection, and Retium tablets at its manufacturing/research facility in Ansan, Gyeonggi Province, selling through pharmacies, clinics, hospitals, and wholesalers. In its 68th fiscal year (2025), consolidated revenue rose about 12.2% year-on-year to KRW 175,496 million and separate-entity revenue rose about 13.6% to KRW 170,542 million, while the company had two new drug research programs and three improved new drug research programs underway.

Products & technology

  • Cuallon Eye Drops
  • Cholencina Soft Cap.
  • Ezeroba Tab.
  • Identgelt Injection
  • Retium Tab.

Regulatory approvals

data.go.kr

264 Korean MFDS drug approvals · 1978–2026 / 1 Korean MFDS device approvals · 2014

  • MFDS drugKukje Pitavastatin OD tab. 2mg2026-07-30
    Drug · Prescription · Approval202602222
  • MFDS drugKukje Pitavastatin OD tab. 4mg2026-07-30
    Drug · Prescription · Approval202602223
  • MFDS drugkukje vonoprazan Tab 10mg2026-07-08
    Drug · Prescription · Approval202601982
  • MFDS drugkukje vonoprazan Tab 20mg2026-07-08
    Drug · Prescription · Approval202601983
  • MFDS drugPelofen Tab(Pelubiprofen(micronized))2026-06-30
    Drug · Prescription · Approval202601906
  • MFDS drugEXDUO plus tab. 2.5/80/1.25mg2026-05-06
    Drug · Prescription · Approval202601336
  • MFDS drugEXDUO plus tab. 2.5/160/2.5mg2026-05-06
    Drug · Prescription · Approval202601337
  • MFDS drugEXDUO plus tab. 2.5/160/1.25mg2026-05-06
    Drug · Prescription · Approval202601338
  • MFDS drugRosudipine Tab 5/5mg2026-04-09
    Drug · Prescription · Approval202601021
  • MFDS drugRosudipine Tab 10/5mg2026-04-09
    Drug · Prescription · Approval202601022
  • MFDS drugRosudipine Tab 20/5mg2026-04-09
    Drug · Prescription · Approval202601023
  • MFDS drugEXDUO 2.5/80mg2026-02-25
    Drug · Prescription · Approval202600574
Show 68 more
  • MFDS drugKUKJE GINKGO LEAF DRIDED EXTRACT 120mg2025-10-17
    Drug · OTC · Notification202502694
  • MFDS drugPiperatam Inj, 4.5g(Piperacillin sodium. Tazobactam sodium)2025-10-02
    Drug · Prescription · Approval202502623
  • MFDS drugGLIANCE DUO 12.5/850mg2025-07-08
    Drug · Prescription · Approval202501691
  • MFDS drugGLIANCE DUO 12.5/500mg2025-07-08
    Drug · Prescription · Approval202501692
  • MFDS drugGLIANCE DUO 12.5/1000mg2025-04-17
    Drug · Prescription · Approval202500926
  • MFDS drugLanope Eye drops2024-12-20
    Drug · Prescription · Approval202403034
  • MFDS drugTrazosin tab.2024-11-21
    Drug · Prescription · Approval202402741
  • MFDS drugDikozin tab. 240mg2024-08-14
    Drug · OTC · Notification202401980
  • MFDS drugLEVOKACIN 1.5%(Levofloxacin hydrate)2024-05-10
    Drug · Prescription · Approval202401153
  • MFDS drugNIGOLINE tab.2024-02-29
    Drug · Prescription · Approval202400425
  • MFDS drugJanudi-M Tab.50/1000mg2023-03-13
    Drug · Prescription · Approval202300851
  • MFDS drugJanudi-M Tab.50/500mg2023-03-13
    Drug · Prescription · Approval202300852
  • MFDS drugJanudi-M Tab.50/850mg2023-03-13
    Drug · Prescription · Approval202300853
  • MFDS drugJanudi-M XR Tab.100/1000mg2023-02-17
    Drug · Prescription · Approval202300599
  • MFDS drugJanudi-M XR Tab.50/1000mg2023-02-17
    Drug · Prescription · Approval202300600
  • MFDS drugJanudi-M XR Tab.50/500mg2023-02-17
    Drug · Prescription · Approval202300601
  • MFDS drugFORXIDI-M XR Tab. 5/500mg2023-01-17
    Drug · Prescription · Approval202300273
  • MFDS drugFORXIDI-M XR Tab. 10/500mg2023-01-17
    Drug · Prescription · Approval202300274
  • MFDS drugTABEON SR tab.2022-12-21
    Drug · Prescription · Approval202204558
  • MFDS drugForxiDCM SR Tab. 5/500mg2022-11-10
    Drug · Prescription · Approval202204070
  • MFDS drugForxiDCM SR Tab. 10/500mgRevoked2022-11-10
    Drug · Prescription · Approval202204069
  • MFDS drugONCEEYE Eye Drops 1%(Carboxymethylcellulose sodium)(disposable)2022-06-30
    Drug · OTC · Notification202202694
  • MFDS drugREBAEYE 2%(Rebamipide)2022-06-16
    Drug · Prescription · Approval202202521
  • MFDS drugJOINTOFA 5mg(Tofacitinib citrate)2022-04-20
    Drug · Prescription · Approval202201620
  • MFDS drugGLIANCE DUO 5/500mg2022-04-04
    Drug · Prescription · Approval202201389
  • MFDS drugGLIANCE DUO 5/850mg2022-04-04
    Drug · Prescription · Approval202201390
  • MFDS drugGLIANCE DUO 5/1000mg2022-04-04
    Drug · Prescription · Approval202201391
  • MFDS drugTENELDI-M 20/1000mg2022-04-04
    Drug · Prescription · Approval202201409
  • MFDS drugTENELDI-M 10/750mg2022-04-04
    Drug · Prescription · Approval202201410
  • MFDS drugTENELDI-M 10/500mg2022-04-04
    Drug · Prescription · Approval202201411
  • MFDS drugBrilelor60mg(Ticagrelor)2022-02-04
    Drug · Prescription · Approval202200550
  • MFDS drugBROEYE(Bromfenac sodium sesquihydrate)2022-01-06
    Drug · Prescription · Approval202200106
  • MFDS drugFORXIVIS 10/100mg2022-01-04
    Drug · Prescription · Approval202200043
  • MFDS drugKUKJE HYAL(Sodium Hyaluronate)2021-11-10
    Drug · Prescription · Notification202107382
  • MFDS drugFORXIDI-M 5/1000mg2021-10-29
    Drug · Prescription · Approval202107223
  • MFDS drugFORXIDI-M 10/1000mg2021-10-29
    Drug · Prescription · Approval202107224
  • MFDS drugKUKJE RIVAROXABAN 20mgRevoked2021-04-23
    Drug · Prescription · Approval202103352
  • MFDS drugKUKJE RIVAROXABAN 15mgRevoked2021-04-23
    Drug · Prescription · Approval202103353
  • MFDS drugKUKJE RIVAROXABAN 10mgRevoked2021-04-23
    Drug · Prescription · Approval202103354
  • MFDS drugSITAVIS-S 100mg(Sitagliptin hydrochloride monohydrate)2021-04-06
    Drug · Prescription · Approval202102956
  • MFDS drugSITAVIS-S 25mg(Sitagliptin hydrochloride monohydrate)2021-04-06
    Drug · Prescription · Approval202102957
  • MFDS drugSITAVIS-S 50mg(Sitagliptin hydrochloride monohydrate)2021-04-06
    Drug · Prescription · Approval202102958
  • MFDS drugGLIANCE 10mg(Empagliflozin)2021-02-24
    Drug · Prescription · Approval202101825
  • MFDS drugGLIANCE 25mg(Empagliflozin)2021-02-24
    Drug · Prescription · Approval202101826
  • MFDS drugAPEZET 10/20mg2021-01-08
    Drug · Prescription · Approval202100231
  • MFDS drugAPEZET 10/10mg2021-01-08
    Drug · Prescription · Approval202100232
  • MFDS drugAPEZET 10/40mgRevoked2021-01-08
    Drug · Prescription · Approval202100230
  • MFDS drugCOLENSINA(Choline alfoscerate)2020-11-30
    Drug · Prescription · Approval202008371
  • MFDS drugDITOREN(Cefditoren pivoxil)2020-11-25
    Drug · Prescription · Approval202008182
  • MFDS drugTENELDI 20mg(Teneligliptin hydrochloride hydrate)2020-11-05
    Drug · Prescription · Approval202007626
  • MFDS drugKUKJE GINKGO LEAF EXTRACTRevoked2020-09-16
    Drug · OTC · Notification202006399
  • MFDS drugFORXIDI 10mg(Dapagliflozin anhydrous lactose mixture)2020-07-23
    Drug · Prescription · Approval202005319
  • MFDS drugFORXIDI 5mg(Dapagliflozin anhydrous lactose mixture)Revoked2020-07-23
    Drug · Prescription · Approval202005318
  • MFDS drugTHY-N(Thymosin α1)Revoked2020-05-22
    Drug · Prescription · Approval202003767
  • MFDS drugOMECIN(Omega-3-acid ethyl esters 90)2020-05-19
    Drug · Prescription · Approval202003634
  • MFDS drugKUKJE LEVOFLOXACIN HYDRATE(For export)2020-05-06
    Drug · Prescription · Approval202003289
  • MFDS drugALLEPATADINE 0.7%(Olopatadine hydrochloride)2020-04-29
    Drug · Prescription · Approval202003227
  • MFDS drugUTANAL 0.4mg(Tamsulosin hydrochloride)2020-04-22
    Drug · Prescription · Approval202002875
  • MFDS drugKUKJE MOSARIDE 15mg(Mosapride citrate hydrate)2020-04-22
    Drug · Prescription · Approval202002901
  • MFDS drugKUKJE MOXIFLOXACIN HYDROCHLORIDE(For export)2020-04-09
    Drug · Prescription · Approval202002505
  • MFDS drugNEOBENZOLE(Albendazole)Revoked2020-04-02
    Drug · OTC · Notification202002321
  • MFDS drugKUKJE LINCOMYCIN HYDROCHLORIDE HYDRATE 600mgRevoked2020-03-27
    Drug · Prescription · Notification202002164
  • MFDS drugEpinawon Tab.2020-03-18
    Drug · Prescription · Approval202001881
  • MFDS drugPOLEMAC(Polaprezinc)Revoked2020-03-11
    Drug · Prescription · Approval202001698
  • MFDS drugPAFECTON PLUS2020-03-09
    Drug · Prescription · Approval202001616
  • MFDS drugGLAVIS 1000mg(Metformin hydrochloride)2020-03-05
    Drug · Prescription · Approval202001548
  • MFDS drugDIQUEYE(Diquafosol sodium)(Disposable)2020-02-21
    Drug · Prescription · Approval202001277
  • MFDS drugNAFUDI(Lafutidine)2019-12-24
    Drug · Prescription · Approval201908602

Showing the 80 most recent of 265 records.

Clinical trials

data.go.kr

46 MFDS clinical trial authorisations · 2012–2025 (Bioequivalence 29 · Phase 1 11 · Phase 3 3 · Phase 2a 1 · Phase 2 1)

  • BioequivalenceKJG25-012025-09-01

    2 trial sites

  • BioequivalenceKJD24-012024-06-04

    2 trial sites

  • BioequivalenceKJD23-012024-01-22

    2 trial sites

  • Phase 2aTFC-0032023-05-25

    2 trial sites

  • BioequivalenceKJD23-012023-05-24

    2 trial sites

  • Phase 1KJD22-032023-01-16

    1 trial site

  • Phase 1KJD22-032023-01-02

    1 trial site

  • BioequivalenceKJD22-022022-09-29

    2 trial sites

  • BioequivalenceKJD21-042021-09-14

    2 trial sites

  • BioequivalenceKJD21-042021-09-13

    2 trial sites

  • BioequivalenceKJD21-032021-06-17

    2 trial sites

  • BioequivalenceKJD20-032021-03-12

    2 trial sites

Show 34 more
  • BioequivalenceKJD20-032021-03-12

    2 trial sites

  • BioequivalenceKJD20-042020-12-21

    2 trial sites

  • BioequivalenceKJD20-052020-09-10

    2 trial sites

  • Phase 2HCS-0012020-07-10
  • BioequivalenceKJD20-022020-06-19

    2 trial sites

  • BioequivalenceKJD20-012020-05-25

    2 trial sites

  • Phase 3TFC-0032020-03-17

    27 trial sites

  • BioequivalenceKJD19-022020-02-04

    2 trial sites

  • BioequivalenceKJD19-062019-11-06

    2 trial sites

  • Bioequivalence국제로잘탄플러스에프정2019-07-16

    2 trial sites

  • Phase 2b/3KSR-0012019-07-10

    16 trial sites

  • Bioequivalence유타날캡슐0.4밀리그램(탐스로신염산염)2019-04-19

    2 trial sites

  • Bioequivalence디토렌세립(세프디토렌피복실)2019-04-16

    2 trial sites

  • Bioequivalence유타날캡슐0.4밀리그램(탐스로신염산염)2019-04-16

    2 trial sites

  • Bioequivalence글라비스정1000밀리그램(메트포르민염산염)2019-03-15

    2 trial sites

  • BioequivalenceKJD19-012019-01-22

    2 trial sites

  • Phase 1KSR-0012018-09-17

    1 trial site

  • Bioequivalence안티그렐서방정(사르포그렐레이트염산염)2018-03-23

    2 trial sites

  • Bioequivalence레티움정(도베실산칼슘수화물)2017-12-28

    2 trial sites

  • Phase 1HCS-0012017-10-16

    1 trial site

  • Bioequivalence트라디엠듀오정 2.5/1000mg2017-01-18

    2 trial sites

  • Phase 3KJCS-0052016-12-14

    5 trial sites

  • Bioequivalence트라디엠정 5mg(리나글립틴)2016-11-21

    2 trial sites

  • Bioequivalence콜렌시아정(콜린알포세레이트)2016-10-26

    2 trial sites

  • Phase 1TFC-0032016-06-29

    1 trial site

  • Bioequivalence에릭손정(에페리손염산염)2016-04-27

    2 trial sites

  • Phase 3INT-21502015-11-09

    13 trial sites

  • Phase 1TFC-0032015-11-06

    1 trial site

  • Bioequivalence니코놉서방정(부프로피온염산염)2015-10-14

    2 trial sites

  • Phase 1INT-21502015-03-25

    1 trial site

  • Phase 1INT-21502014-11-20

    1 trial site

  • Phase 1맥시그라구강붕해정50밀리그램(실데나필시트르산염)2012-05-16

    1 trial site

  • Phase 1맥시그라구강붕해정50밀리그램(실데나필시트르산염)2012-04-23

    1 trial site

  • Phase 1맥시그라구강붕해정50밀리그램(실데나필시트르산염)2012-04-20

    1 trial site

R&D and key agreements

Source: DART corporate disclosure

신약 연구(2건) · Two new drug programs underway as of December 31, 2025; specific names/indications not disclosed in the source

개량신약 연구(3건) · Three improved new drug programs underway as of December 31, 2025; specific names/indications not disclosed in the source

Not yet compiled: business overview. Send us materials and we will add them

Companies approved for the same productsPharma & CDMO

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

Huvitz Co., Ltd.1 shared

KOSDAQ-listed medical device company producing auto refractors, auto lensmeters, and other ophthalmic equipment.

IL DONG PHARMACEUTICAL CO., LTD.100

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Yuyu Pharma, Inc.100

Founded in 1941 and listed on the KOSPI in 1975, Yuyu Pharma is a pharmaceutical company with a co-promotion agreement with Dong-A ST for Tanamin.

ILDONG HOLDINGS CO.,LTD100

Founded in 1941 and listed on the KOSPI in 1975, Ildong Holdings is the holding company of the Ildong Pharmaceutical Group, overseeing pharmaceutical, aesthetic medical device, and drug development affiliates.

Medy-Tox Inc.99

Founded 2000, KOSDAQ-listed 2009, Medy-Tox develops and exports botulinum toxin biopharmaceuticals including Meditoxin and Innotox.

GC Biopharma Corp.97

KOSPI-listed comprehensive pharmaceutical company specializing in blood products and vaccines, with FDA-approved immunoglobulin ALYGLO.

BIO-FD&C CO.,LTD.85

Founded 2005, KOSDAQ-listed 2022, BIO-FD&C develops plant-cell platform-based cosmeceutical materials and biopharma pipelines.

DAEWON PHARMACEUTICAL CO.,LTD85

KOSPI-listed pharmaceutical company behind Coldwon cold medicine and Jangdaewon probiotics, developing a P-CAB drug pipeline.

SAMSUNG BIOLOGICS CO.,LTD.85

Founded 2011, listed 2016 — Samsung Biologics is a biopharma CDMO with 785,000L capacity across five Songdo plants.

GENOLUTION INC.85

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

HANDOK Inc.85

KOSPI-listed comprehensive pharma company behind Amaryl diabetes drug and the USD 86.25M HL5101 anticancer out-license deal.

HL GENOMICS Co., Ltd.85

Sources and updates

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

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