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Pharma & CDMOKOSDAQ 086450483 approvals61 trials

DongKookPharmaceuticalCo.,Ltd.

Official website

KOSDAQ-listed comprehensive healthcare and pharmaceutical company behind the gum treatment Insadol and the wound-care ointment Madecassol.

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Business overview

Source: DART corporate disclosure

Founded in 1968 and listed on KOSDAQ in 2007, DongKook Pharmaceutical is a comprehensive pharmaceutical company spanning OTC drugs, prescription drugs, and healthcare products. Its OTC lineup includes the gum disease treatment Insadol, the plant-based wound treatment Madecassol, the mouth ulcer treatment Oramedy, and the menopause treatment Feramin-Q, while its prescription drug lineup includes Pamiray, Korea's only self-synthesized contrast agent, the anticancer drug Leuprolide Depot, and the general anesthetic Fopol; its healthcare division operates the Centellian24 cosmetics and health functional food brand. The company exports platform-technology products based on microspheres and liposomes to Europe, Asia, the Middle East, Africa, and Latin America, became the first in Korea to pass EU GMP standards for its injectable products, and derives about 85% of its OTC sales through direct transactions.

Products & technology

  • InsadolGum disease treatment
  • MadecassolPlant-based wound treatment
  • OramedyMouth ulcer treatment
  • Feramin-QMenopause symptom treatment
  • PamirayContrast agent
  • Leuprolide DepotAnticancer drug
  • FopolGeneral anesthetic
  • Centellian24Dermocosmetics and health functional food brand

Regulatory approvals

data.go.kr

437 Korean MFDS drug approvals · 1977–2026 / 46 Korean MFDS device approvals · 2010–2026

  • MFDS drugMega Chondro Max 1200 oral gel2026-08-20
    Drug · OTC · Notification202602417
  • MFDS drugEdogaban Tab. 15mg(Edoxaban Tosylate Hydrate)2026-07-31
    Drug · Prescription · Approval202602224
  • MFDS drugEdogaban Tab. 30mg(Edoxaban Tosylate Hydrate)2026-07-31
    Drug · Prescription · Approval202602226
  • MFDS drugPolmiron Capsule2026-07-27
    Drug · Prescription · Approval202602164
  • MFDSDressing, fluid-impermeable film2026-07-23
    Product approval · Class 2제인 26-4682 호
  • MFDS drugRosutanzet OD Tab. 10/20mg (Ezetimibe, Rosuvastatin Calcium)2026-06-30
    Drug · Prescription · Approval202601853
  • MFDS drugRosutanzet OD Tab. 10/5mg (Ezetimibe, Rosuvastatin Calcium)2026-06-30
    Drug · Prescription · Approval202601856
  • MFDS drugRosutanzet OD Tab. 10/10mg (Ezetimibe, Rosuvastatin Calcium)2026-06-30
    Drug · Prescription · Approval202601857
  • MFDS drugGynomella vaginal soft capsule2026-05-28
    Drug · OTC · Notification202601540
  • MFDS drugCens RN Cream2026-05-28
    Drug · OTC · Notification202601541
  • MFDS drugAmlospine-S Tab. 1.25mg (S-Amlodipine besylate 2.5 hydrate)2026-05-11
    Drug · Prescription · Approval202601354
  • MFDS drugVonoti Tab.2026-04-30
    Drug · Prescription · Approval202601315
Show 68 more
  • MFDS drugEntamid soft capsule 40mg(Enzalutamide)2026-04-27
    Drug · Prescription · Approval202601243
  • MFDS drugTegopid Tab. 25mg(Tegoprazan)2026-04-20
    Drug · Prescription · Approval202601117
  • MFDS drugTegopid Tab. 50mg(Tegoprazan)2026-04-20
    Drug · Prescription · Approval202601118
  • MFDS drugEdogaban Tab. 60mg(Edoxaban Tosylate Hydrate)2026-04-14
    Drug · Prescription · Approval202601078
  • MFDS drugArimantin tablet 10/20mg2026-03-16
    Drug · Prescription · Approval202600759
  • MFDS drugCold Nose Ssac Tablet2026-02-05
    Drug · OTC · Notification202600327
  • MFDS drugMelatension Cream 2%(Hydroquinone)2026-01-28
    Drug · OTC · Notification202600238
  • MFDS drugMelatension Cream4%(Hydroquinone)2026-01-28
    Drug · OTC · Notification202600239
  • MFDS drugVicadol Soft Capsule 1mcg(Alfacalcidol)2025-12-09
    Drug · OTC · Notification202503211
  • MFDS drugVicadol Soft Capsule 0.5mcg(Alfacalcidol)2025-12-09
    Drug · OTC · Notification202503212
  • MFDS drugFulverant Prefilled Injection(Fulvestrant)2025-12-08
    Drug · Prescription · Approval202503198
  • MFDS drugColdpro-Phen Soft Capsule2025-11-17
    Drug · OTC · Notification202502969
  • MFDS drugColdpro-Phen Cough Soft Capsule2025-11-17
    Drug · OTC · Notification202502970
  • MFDS drugColdpro-Phen Nose Soft Capsule2025-11-14
    Drug · OTC · Notification202502952
  • MFDS drugFree Easy Tablet2025-11-06
    Drug · OTC · Notification202502878
  • MFDS drugInsacure Gel(Sodium Hyaluronate)2025-10-31
    Drug · OTC · Notification202502833
  • MFDS drugRibonheal inj. (Polydeoxyribonucleotide sodium)2025-09-26
    Drug · Prescription · Approval202502556
  • MFDSThermometer, electronic2025-09-18
    Product approval · Class 2수인 25-4548 호
  • MFDS drugOrabiten Active Tab.2025-08-20
    Drug · OTC · Notification202502162
  • MFDS drugMega Chondro Up800 Tablet2025-07-31
    Drug · OTC · Notification202502005
  • MFDS drugMillifit injection(Deoxycholic acid)2025-07-25
    Drug · Prescription · Approval202501930
  • MFDS drugLinakhanempa Tab.25/5mg(Empagliflozin, Linagliptin)2025-07-15
    Drug · Prescription · Approval202501803
  • MFDS drugLinakhanempa Tab.10/5mg(Empagliflozin, Linagliptin)2025-07-15
    Drug · Prescription · Approval202501804
  • MFDS drugEmpeulzinmet XR Tablet 5/1000mg2025-07-09
    Drug · Prescription · Approval202501717
  • MFDS drugEmpeulzinmet XR Tablet 12.5/1000mg2025-07-09
    Drug · Prescription · Approval202501718
  • MFDS drugEmpeulzinmet XR Tablet 10/1000mg2025-07-09
    Drug · Prescription · Approval202501719
  • MFDS drugEmpeulzinmet XR Tablet 25/1000mg2025-07-09
    Drug · Prescription · Approval202501720
  • MFDS drugSense-on Speed Double Action Liquid2025-06-10
    Drug · OTC · Notification202501426
  • MFDS drugCheesen Tablet 600mg(Diosmin)2025-05-13
    Drug · OTC · Notification202501166
  • MFDS drugPanbiotin Tab. (Biotin)2025-05-12
    Drug · OTC · Notification202501147
  • MFDS drugArgishot. sol.(L-Arginine-L-Aspartate Hydrate)2025-04-28
    Drug · OTC · Notification202501015
  • MFDS drugEficozole Topical Solution2025-04-16
    Drug · Prescription · Approval202500920
  • MFDS drugCensheal Gel2025-04-03
    Drug · OTC · Notification202500789
  • MFDS drugAmphosom inj.(Liposomal Amphotericin B)2025-03-27
    Drug · Prescription · Approval202500709
  • MFDS drugExoraxen Tablet 500/20mg (Naproxen, Esomeprazole Magnesium Trihydrate)2025-03-17
    Drug · Prescription · Approval202500589
  • MFDS drugCenscarna Gel2025-03-14
    Drug · OTC · Notification202500569
  • MFDS drugUresco Tab. 0.5/5mg(dutasteride,tadalafil)2025-01-23
    Drug · Prescription · Approval202500172
  • MFDS drugPansidil 3% Solution (Minoxidil)2024-12-23
    Drug · OTC · Notification202403057
  • MFDS drugFimamono Tablet 30mg (Fimasartan potassium trihydrate)2024-12-11
    Drug · Prescription · Approval202402924
  • MFDS drugFimamono Tablet 60mg (Fimasartan potassium trihydrate)2024-12-11
    Drug · Prescription · Approval202402925
  • MFDS drugSense-quette Tab.2024-11-26
    Drug · OTC · Approval202402775
  • MFDS drugPranpid Tab. 50mg(Pranlukast Hydrate)2024-11-06
    Drug · Prescription · Approval202402624
  • MFDS drugDrymedi Gel2024-09-30
    Drug · OTC · Notification202402344
  • MFDS drugPetaflu inj(Peramivir hydrate)2024-09-20
    Drug · Prescription · Approval202402278
  • MFDS drugSermigoline Tab. 10mg(Nicergoline)2024-08-06
    Drug · Prescription · Approval202401916
  • MFDSGraft/prosthesis, biomaterial2024-08-05
    Product approval · Class 4제허 24-526 호
  • MFDS drugSitakandapeulmet SR Tab. 10/100/1000mg2024-07-24
    Drug · Prescription · Approval202401787
  • MFDS drugSitakandapeulmet SR Tab. 5/50/1000mg2024-07-24
    Drug · Prescription · Approval202401788
  • MFDS drugGinkgota Tablet 240mg (Ginkgo Leaf Dried Extract)2024-07-23
    Drug · OTC · Notification202401784
  • MFDS drugCenskin Cream2024-07-05
    Drug · OTC · Notification202401650
  • MFDSBandage, compression2024-07-02
    Product approval · Class 1수신 24-1211 호
  • MFDS drugRabed-on Tab. 10/600mg(Rabeprazole Sodium, Precipitated Calcium Carbonate)2024-06-20
    Drug · Prescription · Approval202401498
  • MFDS drugRabed-on Tab. 20/600mg(Rabeprazole Sodium, Precipitated Calcium Carbonate)2024-06-20
    Drug · Prescription · Approval202401499
  • MFDS drugOrapainQ Gel2024-06-19
    Drug · OTC · Notification202401470
  • MFDS drugOlmevikar HCT Tab. 5/40/12.5mg2024-05-31
    Drug · Prescription · Approval202401352
  • MFDS drugOlmevikar HCT Tab. 2.5/40/12.5mg2024-05-31
    Drug · Prescription · Approval202401353
  • MFDS drugOlmevikar HCT Tab. 2.5/20/12.5mg2024-05-31
    Drug · Prescription · Approval202401354
  • MFDS drugApigaban Tab. 2.5mg(apixaban)2024-05-14
    Drug · Prescription · Approval202401178
  • MFDS drugInsacureSolution(Sodium hyaluronate)2024-05-08
    Drug · OTC · Notification202401124
  • MFDS drugSugadex Prefilled Injection (Sugammadex Sodium)2024-04-30
    Drug · Prescription · Approval202401070
  • MFDS drugApigaban Tab. 5mg(apixaban)2024-04-11
    Drug · Prescription · Approval202400817
  • MFDS drugMegachonti 800 Tablet2024-04-03
    Drug · OTC · Notification202400751
  • MFDS drugLinakanmet XR Tablet 2.5/1000mg2024-03-22
    Drug · Prescription · Approval202400608
  • MFDS drugLinakanmet XR Tablet 5/1000mg2024-03-22
    Drug · Prescription · Approval202400609
  • MFDS drugAtovanduo Tablet 10/5mg(Ezetimibe, Atorvastatin calcium trihydrate)2024-03-15
    Drug · Prescription · Approval202400543
  • MFDSBandage, compression2024-03-14
    Product approval · Class 1수신 24-434 호
  • MFDS drugRelicheck Injection(Gonadorelin acetate)2024-03-08
    Drug · Prescription · Notification202400497
  • MFDS drugHyaron L prefilled Inj. (BDDE cross-linked sodium hyaluronate gel)2024-03-05
    Drug · Prescription · Approval202400456

Showing the 80 most recent of 483 records.

Clinical trials

data.go.kr

61 MFDS clinical trial authorisations · 2012–2026 (Bioequivalence 42 · Phase 1 14 · Phase 3 4 · Phase 2 1)

  • BioequivalenceDKF-4292026-08-12

    1 trial site

  • BioequivalenceDKF-4292026-08-12

    1 trial site

  • BioequivalenceDKF-4572026-03-13

    2 trial sites

  • BioequivalenceDKF-4582026-02-24

    2 trial sites

  • Phase 1DKF-4652026-02-19

    2 trial sites

  • Phase 1DKF-3352025-11-20

    2 trial sites

  • Phase 1DKF-4602025-10-20

    2 trial sites

  • BioequivalenceDKF-4322025-08-19

    2 trial sites

  • BioequivalenceDKF-4622025-06-12

    2 trial sites

  • Phase 1DKF-4602025-04-02

    2 trial sites

  • Bioequivalence에도가반정60밀리그램(에독사반토실산염수화물)(DKF-427)2025-01-09

    2 trial sites

  • BioequivalenceDKF-417F2024-08-20

    2 trial sites

Show 49 more
  • BioequivalenceDKF-417F2024-03-18

    2 trial sites

  • Bioequivalence보노티정20밀리그램(보노프라잔푸마르산염)[DKF-424]2024-02-27

    2 trial sites

  • BioequivalenceDKF-4472023-11-01

    2 trial sites

  • Phase 3DKF-MA1022023-10-10

    8 trial sites

  • Bioequivalence로수탄젯정10/10밀리그램(DKF-400)2023-08-28

    2 trial sites

  • BioequivalenceDKF-4352023-05-01

    2 trial sites

  • BioequivalenceDKF-4262023-03-29

    2 trial sites

  • BioequivalenceDKF-417F2023-03-24

    2 trial sites

  • BioequivalenceDKF-MA1012022-12-19

    2 trial sites

  • Phase 1DKF-3352022-07-04

    2 trial sites

  • Bioequivalence아세탈정(아세클로페낙)2022-03-30

    2 trial sites

  • Bioequivalence팜클린정250밀리그램(팜시클로비르)(DKF-402)2022-03-28

    2 trial sites

  • Bioequivalence라비스타정(DKF-386)2021-12-01

    2 trial sites

  • Bioequivalence레바피드정(레바미피드)(DKF-387)2021-11-26

    2 trial sites

  • Bioequivalence라베드정20밀리그램(라베프라졸나트륨)(DKF-372)2021-11-24

    2 trial sites

  • Bioequivalence피타론정(피타바스타틴칼슘)(DKF-382)2021-11-24

    2 trial sites

  • Bioequivalence록페린정(록소프로펜나트륨수화물)(DKF-404)2021-10-27

    2 trial sites

  • Phase 1DKF-4072021-10-22

    2 trial sites

  • Bioequivalence클로렐정(클로피도그렐황산수소염)(DKF-388)2021-10-08

    2 trial sites

  • Bioequivalence모사프론정(DKF-385)2021-07-20

    2 trial sites

  • Bioequivalence로수탄젯정10/10밀리그램(DKF-400)2021-06-16

    2 trial sites

  • Bioequivalence엑소라졸정40밀리그램(DKF-373)2021-05-11

    2 trial sites

  • Phase 1DKF-3612021-05-10

    2 trial sites

  • Bioequivalence싱귤몬정10밀리그램(DKF-389)2020-12-09

    2 trial sites

  • Phase 3DKF-3132020-07-09

    19 trial sites

  • Bioequivalence암로스핀정(DKF-381)2020-05-28

    2 trial sites

  • Phase 3GHX02정2020-04-16

    4 trial sites

  • Bioequivalence플루코졸정150mg(DKF-368)2020-03-31

    2 trial sites

  • Phase 1DKF-3402020-02-20

    1 trial site

  • BioequivalenceDKF-3702020-01-30

    2 trial sites

  • Bioequivalence아세탈정(아세클로페낙)2019-11-27

    2 trial sites

  • Bioequivalence암로스핀에스정5밀리그램(에스암로디핀베실산염2.5수화물)2019-11-25

    2 trial sites

  • Bioequivalence동국암포테리신주사(DKF-5122)2019-03-13

    1 trial site

  • Phase 1DKF-3402019-01-22

    1 trial site

  • BioequivalenceDKF-3342018-10-15

    1 trial site

  • Phase 3DKM4122018-08-22

    10 trial sites

  • Bioequivalence동국디에노게스트정2018-04-30

    2 trial sites

  • Bioequivalence동국바제독시펜정20mg(바제독시펜아세테이트)2017-12-13

    2 trial sites

  • Bioequivalence동국알렌드론산나트륨액 20 mL2017-08-29

    2 trial sites

  • Phase 1DKF-3132017-02-23

    1 trial site

  • BioequivalenceDK-LPD2017-01-24

    1 trial site

  • Phase 1DKF-3132016-01-07

    1 trial site

  • Phase 2DKF-3172015-12-01
  • Phase 1DKF-3102015-10-27

    1 trial site

  • Bioequivalence동국실로도신구강붕해정4밀리그램2015-08-03

    2 trial sites

  • Phase 1DKF-3132015-01-06

    1 trial site

  • Bioequivalence동국암포테리신주사2014-04-04

    2 trial sites

  • Phase 1DKF-3132013-07-22

    1 trial site

  • Bioequivalence암로살탄정5/160밀리그램2012-10-31

    2 trial sites

R&D and key agreements

Source: DART corporate disclosure

플랫폼기술(마이크로스피어, 리포좀) · 상업화(수출중) · Products exported to Europe, Asia, the Middle East, Africa, and Latin America

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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.

BNC KOREA, Inc.5 shared

Founded and listed on the KOSDAQ in 2016, BNC Korea is a biohealthcare company specializing in HA fillers, botulinum toxin, and dermo-cosmetics.

Humedix Co., Ltd.5 shared

KOSDAQ-listed aesthetics and CMO company behind the Elravie/Revolax hyaluronic-acid fillers and Leedstox botulinum toxin.

PharmaResearch Co., Ltd.5 shared

KOSDAQ-listed medical device company producing PDRN pharmaceuticals, HA fillers, and Rejuran-branded cosmetics.

HANS BIOMED CORPORATION4 shared

KOSDAQ-listed medical device company producing human tissue implants Bella Cell HD and SureFuse.

Wonbiogen Co.,Ltd.4 shared

Wonbiogen Co.,Ltd., established September 2018, listed on KOSDAQ in December 2018, manufactures wound dressings and moist wound dressings.

BioPlus Co., Ltd3 shared

Founded in 2003 and KOSDAQ-listed in 2021, BioPlus develops HA-based bio medical devices and biopharmaceuticals using its proprietary MDM Technology platform.

DongBang Medical Co., Ltd.3 shared

KOSDAQ-listed medical device maker producing disposable acupuncture needles, cupping cups, and hyaluronic acid dermal fillers.

DONGWHA PHARM.CO.,LTD3 shared

Dongwha Pharm, founded in 1897 and KOSPI-listed in 1976, is a diversified company centered on pharmaceuticals.

JETEMA Co.,Ltd.3 shared

Founded 2009, listed on KOSDAQ in 2019, JETEMA develops hyaluronic acid fillers, botulinum toxin biopharmaceuticals, and lifting threads.

SEJONG MEDICAL Co.Ltd.,3 shared

Founded in 2010 and KOSDAQ-listed in 2018, Sejong Medical manufactures laparoscopic surgical instruments.

CU MEDICAL SYSTEMS Inc.2 shared

Founded in 2001 and KOSDAQ-listed in 2011, CU Medical Systems makes AEDs and other emergency medical devices.

Medy-Tox Inc.2 shared

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

Sources and updates

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

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