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Pharma & CDMOKOSDAQ 067080290 approvals61 trials

DAE HWA PHARM CO., LTD

Official website

KOSDAQ-listed pharmaceutical company behind the world's first oral paclitaxel Liporaxel (DHP107) and the Amalian dermal filler.

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Market cap

Business overview

Source: DART corporate disclosure

Founded in 1989 and listed on KOSDAQ in 2003, Dae Hwa Pharmaceutical is a pharmaceutical company spanning drug manufacturing, wholesale distribution, and aesthetic medical devices. It sells the infection treatment Cephamezil, the digestive treatment Furosfan, the patch products Cataplasma and Plasta, and the facial filler Amalian, and in 2018 signed a 10-year, KRW 100 billion exclusive supply agreement for Amalian with China's Sinopharm Zhijun Pharmaceutical. Its Liporaxel (DHP107), the world's first oral paclitaxel formulation, was out-licensed to China, Taiwan, Hong Kong, and Thailand in 2017 for a total of KRW 28.3 billion and received NMPA marketing approval in China in September 2024; for gastric cancer it received EMA Orphan Drug Designation in February 2024 and was listed on China's National Reimbursement Drug List (NRDL) in December 2025.

Products & technology

  • Cephamezil Tab.Treatment for infectious diseases
  • Furosfan Tab.Digestive system treatment
  • Cataplasma / Plasta patchesAnti-inflammatory analgesic patches
  • Amalian fillerAesthetic medical device for facial wrinkle correction
  • Liporaxel (DHP107)World's first oral paclitaxel anticancer drug

Regulatory approvals

data.go.kr

284 Korean MFDS drug approvals · 1984–2026 / 6 Korean MFDS device approvals · 2006–2025

  • MFDS drugDAEHWA Pospentop Alpha Plaster2026-07-31
    Drug · OTC · Notification202602233
  • MFDS drugEdoxflo Tab. 30mg2026-07-30
    Drug · Prescription · Approval202602205
  • MFDS drugEdoxflo Tab. 15mg2026-07-30
    Drug · Prescription · Approval202602211
  • MFDS drugEdoxflo Tab. 60mg2026-07-29
    Drug · Prescription · Approval202602190
  • MFDS drugPeltrone Tab.2026-06-24
    Drug · Prescription · Approval202601785
  • MFDS drugCereDM Tab. 10/20mg2026-05-12
    Drug · Prescription · Approval202601376
  • MFDS drugKafortri Tab. 2.5/80/1.25mg2026-04-29
    Drug · Prescription · Approval202601280
  • MFDS drugKafortri Tab. 2.5/160/2.5mg2026-04-29
    Drug · Prescription · Approval202601281
  • MFDS drugKafortri Tab. 2.5/160/1.25mg2026-04-29
    Drug · Prescription · Approval202601282
  • MFDS drugMagnesplus tab.2026-04-13
    Drug · OTC · Notification202601057
  • MFDS drugDH Cool Plaster2026-02-24
    Drug · OTC · Notification202600514
  • MFDS drugDaehwa rebamipide SR Tablet 150mg2026-01-14
    Drug · Prescription · Approval202600121
Show 68 more
  • MFDSGraft/prosthesis, biomaterial2025-12-08
    Product approval · Class 4수허 25-210 호
  • MFDSGraft/prosthesis, biomaterial2025-11-27
    Product approval · Class 4수허 25-201 호
  • MFDS drugDaehwa Diclo Cataplasma2025-09-08
    Drug · OTC · Notification202502368
  • MFDS drugEnglina tab 10/5 mg2025-08-22
    Drug · Prescription · Approval202502188
  • MFDS drugEnglina tab 25/5 mg2025-07-07
    Drug · Prescription · Approval202501684
  • MFDS drugOn-Q Coin Plasta2025-05-23
    Drug · OTC · Notification202501291
  • MFDS drugLiporaxel Sol.2024-10-04
    Drug · Prescription · Approval202402377
  • MFDS drugPLOCFEN Plaster 40mg2024-09-05
    Drug · OTC · Notification202402168
  • MFDS drugTamax Tab. 240mg(Ginkgo leaf dry extract)2024-07-26
    Drug · OTC · Notification202401808
  • MFDS drugGastric XR Tab 37.5mg2024-04-25
    Drug · Prescription · Approval202400970
  • MFDS drugCicurin Tab.30mg2024-01-24
    Drug · Prescription · Approval202400183
  • MFDS drugNewOnQ Plaster2023-04-03
    Drug · OTC · Approval202301117
  • MFDS drugSitaviance Duo Tablet 50/850mg2023-03-06
    Drug · Prescription · Approval202300758
  • MFDS drugSitaviance Duo Tablet 50/500mg2023-03-06
    Drug · Prescription · Approval202300759
  • MFDS drugSitaviance Duo Tablet 50/1000mg2023-03-06
    Drug · Prescription · Approval202300760
  • MFDS drugSitaviance Duo XR Tablet 50/500mg2023-02-16
    Drug · Prescription · Approval202300577
  • MFDS drugSitaviance Duo XR Tablet 50/1000mg2023-02-16
    Drug · Prescription · Approval202300578
  • MFDS drugSitaviance Duo XR Tablet 100/1000mg2023-02-16
    Drug · Prescription · Approval202300579
  • MFDS drugGastric XR Tab.2023-02-03
    Drug · Prescription · Approval202300452
  • MFDS drugTapazin Tab. 10mg2023-01-30
    Drug · Prescription · Approval202300370
  • MFDS drugTapazin Tab. 5mg2023-01-30
    Drug · Prescription · Approval202300371
  • MFDS drugTapazinplus SR Tab. 10/500mg2023-01-12
    Drug · Prescription · Approval202300229
  • MFDS drugTapazinplus SR Tab. 10/1000mg2023-01-12
    Drug · Prescription · Approval202300230
  • MFDS drugOlistat Tab. 60mg2023-01-06
    Drug · Prescription · Approval202300155
  • MFDS drugOlistat Tab. 120mg2022-11-18
    Drug · Prescription · Approval202204142
  • MFDS drugPicosulfate Tablet2022-11-15
    Drug · Prescription · Notification202204102
  • MFDS drugMarnaef Tab.2022-03-16
    Drug · OTC · Notification202201078
  • MFDS drugTAPADUO TAB 10/100mg2022-01-04
    Drug · Prescription · Approval202200066
  • MFDS drugHemorex S Suppositories2021-12-10
    Drug · OTC · Notification202107875
  • MFDS drugIPROTOP Plaster2021-06-09
    Drug · OTC · Approval202104481
  • MFDS drugLamoz ODF(lamosetron HCL)Revoked2021-05-31
    Drug · Prescription · Approval202104276
  • MFDS drugZoledron Inj. 5mg/100mL2021-03-25
    Drug · Prescription · Approval202102615
  • MFDS drugDaehwa Bromhexine HCl Tablet2021-03-19
    Drug · OTC · Notification202102461
  • MFDS drugSitaviance Tablet 50mg (Sitagliptin HCl hydrate)2021-03-04
    Drug · Prescription · Approval202102015
  • MFDS drugSitaviance Tablet 25mg (Sitagliptin HCl hydrate)2021-03-04
    Drug · Prescription · Approval202102016
  • MFDS drugSitaviance Tablet 100mg (Sitagliptin HCl hydrate)2021-03-04
    Drug · Prescription · Approval202102017
  • MFDS drugAtorvaF Tab. 10/10mg2021-02-18
    Drug · Prescription · Approval202101518
  • MFDS drugAtorvaF Tab. 10/20mg2021-02-18
    Drug · Prescription · Approval202101519
  • MFDS drugAtorvaF Tab. 10/40mgRevoked2021-02-18
    Drug · Prescription · Approval202101520
  • MFDS drugPRTOP Plaster(Piroxicam)2020-10-22
    Drug · OTC · Notification202007234
  • MFDS drugDAEHWA FAMOTIDINE10mg Tab.Revoked2020-09-17
    Drug · OTC · Notification202006414
  • MFDS drugZang-Free Oro-dispersible film(Simethicone)2020-07-13
    Drug · OTC · Notification202005038
  • MFDS drugTears Eye DropsRevoked2020-06-26
    Drug · Prescription · Notification202004684
  • MFDS drugBrolain Enteric Coated Tab.2020-05-28
    Drug · OTC · Notification202003978
  • MFDS drugDiqusol Eye drops (single use)2020-05-18
    Drug · Prescription · Approval202003601
  • MFDS drugMagnesD Tab.2020-05-08
    Drug · OTC · Notification202003341
  • MFDS drugTelostin Tab. 40/10mgRevoked2020-03-17
    Drug · Prescription · Approval202001836
  • MFDS drugTelostin Tab. 80/20mgRevoked2020-03-17
    Drug · Prescription · Approval202001837
  • MFDS drugTelostin Tab. 40/5mgRevoked2020-03-17
    Drug · Prescription · Approval202001838
  • MFDS drugTelostin Tab. 80/10mgRevoked2020-03-17
    Drug · Prescription · Approval202001839
  • MFDS drugTelostin Tab. 80/20mgRevoked2020-03-17
    Drug · Prescription · Approval202001840
  • MFDS drugTelostin Tab. 80/5mgRevoked2020-03-17
    Drug · Prescription · Approval202001841
  • MFDS drugMarinty Cap.2020-03-10
    Drug · OTC · Notification202001635
  • MFDS drugTrazentin TabRevoked2019-11-07
    Drug · Prescription · Approval201907784
  • MFDS drugTrajenta-duo Tab. 2.5/500mgRevoked2019-10-01
    Drug · Prescription · Approval201907007
  • MFDS drugTrajenta-duo Tab. 2.5/850mgRevoked2019-10-01
    Drug · Prescription · Approval201907008
  • MFDS drugTrajenta-duo Tab. 2.5/1000mgRevoked2019-10-01
    Drug · Prescription · Approval201907009
  • MFDS drugRosuvato Tab 5mg2019-09-27
    Drug · Prescription · Approval201906882
  • MFDS drugFenobe Tab.2019-08-14
    Drug · Prescription · Approval201905775
  • MFDS drugRespela tab.2019-08-07
    Drug · Prescription · Notification201905573
  • MFDS drugLima-A Tab.Revoked2019-08-01
    Drug · Prescription · Approval201905466
  • MFDS drugLinexta Tab.Revoked2019-07-16
    Drug · Prescription · Approval201904744
  • MFDS drugTicabrel Tab 90mgRevoked2019-07-11
    Drug · Prescription · Approval201904674
  • MFDS drugPliocan Cream 5%2019-07-02
    Drug · Prescription · Notification201904500
  • MFDS drugTicabrel Tab 60mgRevoked2019-06-12
    Drug · Prescription · Approval201903824
  • MFDS drugGLIANA Soft Capsule2019-05-16
    Drug · Prescription · Approval201903164
  • MFDS drugAlicete Tab. 10mgRevoked2019-04-25
    Drug · Prescription · Approval201902625
  • MFDS drugTelmitension Plus Tab. 80/12.5mg2019-04-24
    Drug · Prescription · Approval201902559

Showing the 80 most recent of 290 records.

Clinical trials

data.go.kr

61 MFDS clinical trial authorisations · 2012–2026 (Bioequivalence 43 · Phase 1 14 · Phase 3 2 · Phase 2/3 1 · Phase 2b 1)

  • BioequivalenceDHP28472026-06-12

    2 trial sites

  • BioequivalenceDHP28452026-05-22

    2 trial sites

  • BioequivalenceDHP28442025-11-14

    2 trial sites

  • BioequivalenceDHP28352025-09-17

    2 trial sites

  • BioequivalenceDHP28362025-09-01

    2 trial sites

  • Phase 1DHP23062024-11-04

    2 trial sites

  • BioequivalenceDHP28232024-10-22

    2 trial sites

  • BioequivalenceDHP28272024-10-11

    2 trial sites

  • BioequivalenceDHP28242024-09-12

    2 trial sites

  • Phase 1DHP23022023-12-19

    2 trial sites

  • BioequivalenceDHP28192023-10-26

    2 trial sites

  • Phase 1DHP23062023-08-14

    2 trial sites

Show 49 more
  • Phase 1DHP23052023-08-02

    2 trial sites

  • Phase 1DHP23052023-07-07

    2 trial sites

  • BioequivalenceDHP28202023-03-16

    2 trial sites

  • BioequivalenceDHP28112021-07-02

    2 trial sites

  • Phase 1DHP230072021-06-14

    2 trial sites

  • BioequivalenceDHP28022021-05-24

    2 trial sites

  • BioequivalenceDHP28132021-05-13

    2 trial sites

  • BioequivalenceDHP28092021-03-11

    2 trial sites

  • BioequivalenceDHP28052020-11-17

    2 trial sites

  • BioequivalenceDHP28102020-10-15

    2 trial sites

  • BioequivalenceDHP28022020-09-29

    2 trial sites

  • BioequivalenceDHP28022020-09-23

    2 trial sites

  • BioequivalenceDHP28012020-09-04

    2 trial sites

  • BioequivalenceDHP28082020-07-31

    2 trial sites

  • BioequivalenceDHP28032020-07-23

    2 trial sites

  • Phase 1시타비앙듀오엑스알서방정100/1000밀리그램2019-06-25

    2 trial sites

  • Phase 1시타비앙듀오엑스알서방정100/1000밀리그램2019-06-25

    2 trial sites

  • Phase 1시타비앙듀오엑스알서방정50/500밀리그램2019-06-18

    2 trial sites

  • Phase 1시타비앙듀오엑스알서방정50/500밀리그램2019-06-18

    2 trial sites

  • Phase 1시타비앙듀오정50/1000밀리그램2019-06-10

    2 trial sites

  • Phase 1시타비앙정100밀리그램(시타글립틴염산염수화물)2019-05-09

    2 trial sites

  • Bioequivalence하루탐스구강붕해정(탐스로신염산염)2019-02-21

    2 trial sites

  • Bioequivalence설레구강용해필름20밀리그램(타다라필)2018-09-18

    2 trial sites

  • Bioequivalence탑스타틴정20밀리그램(로수바스타틴칼슘)2018-08-10

    2 trial sites

  • Phase 2/3리포락셀액(파클리탁셀)2017-09-11

    21 trial sites

  • Bioequivalence대화와르파린나트륨정5밀리그램2017-01-10

    2 trial sites

  • Bioequivalence올위너정20밀리그램(올메사탄메독소밀)2016-01-11

    2 trial sites

  • Bioequivalence라모즈구강용해필름(라모세트론염산염)2015-12-03

    2 trial sites

  • Bioequivalence대화솔레페나신정10mg2015-12-03

    2 trial sites

  • Bioequivalence하루탐스구강붕해정(탐스로신염산염)2015-11-27

    2 trial sites

  • Bioequivalence베티린정(베포타스틴베실산염)2015-11-27
  • Phase 3리포락셀액(파클리탁셀)2015-11-02

    2 trial sites

  • Phase 2bDHP-14012015-08-10

    16 trial sites

  • Bioequivalence후로스판디정(플로로글루시놀무수물)2015-03-09

    2 trial sites

  • Bioequivalence대화타다라필오디에프20밀리그램2014-10-30

    2 trial sites

  • Bioequivalence바라티스오디에프1밀리그램(엔테카비르)2014-10-30

    2 trial sites

  • Bioequivalence후로스판정(플로로글루시놀수화물)2014-04-15

    2 trial sites

  • Bioequivalence비바스정10/40밀리그램2014-04-09

    2 trial sites

  • Bioequivalence콕스렌캡슐(세레콕시브)2014-03-31

    2 trial sites

  • Phase 1DHP9022013-12-23

    1 trial site

  • Phase 1DHP9022013-11-20

    1 trial site

  • Bioequivalence위코스타정(레바미피드)2013-09-05

    2 trial sites

  • Bioequivalence모렉셀캡슐7.5밀리그램(멜록시캄)2013-06-03
  • Bioequivalence올위너정20밀리그램(올메사탄메독소밀)2013-03-21

    2 trial sites

  • Phase 3리포락셀액(파클리탁셀)2013-02-27

    12 trial sites

  • Bioequivalence대화리바스티그민패취10(리바스티그민)2013-02-01

    2 trial sites

  • Bioequivalence목시플로정400밀리그램(목시플록사신염산염)2012-10-31

    2 trial sites

  • Bioequivalence바라티스정1밀리그램(엔테카비어일수화물)2012-08-06

    2 trial sites

  • Bioequivalence바렉스정(바클로펜)2012-07-25

R&D and key agreements

Source: DART corporate disclosure

리포락셀액(DHP107) 유방암 적응증 확장 · 유방암 · 미국·체코 약동학 및 유방암 2상 완료, 다국적 유방암 임상(한국/중국/헝가리/세르비아/불가리아) 완료, 2025년 4월 MFDS 품목허가 신청 · Chinese partner Haihe Biopharma filed for NMPA approval of the breast cancer indication in June 2025

리포락셀액(DHP107) 위암 2차치료제 · 위암 · 2024년 2월 EMA 희귀의약품 지정(ODD), 2025년 12월 중국 NRDL 등재 · Reimbursement in China began January 1, 2026

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

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

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JEIL PHARMA HOLDINGS INC.1 shared
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OSTEONIC Co., Ltd.1 shared

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DONG-A ST CO.,LTD1 shared

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DongKookPharmaceuticalCo.,Ltd.1 shared

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Sources and updates

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

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