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Pharma & CDMOKOSPI 128940Orphan Drug474 approvals190 trials

Hanmi Pharm. Co., Ltd.

KOSPI-listed pharmaceutical company behind the combination drugs Amosartan (hypertension) and Rosuzet (dyslipidemia).

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Business overview

Source: DART corporate disclosure

Founded and listed on the KOSPI in 2010, Hanmi Pharm is a pharmaceutical manufacturing and sales company. It sells the combination antihypertensive Amosartan, the combination dyslipidemia drug Rosuzet, the GERD treatment Esomezol, the BPH treatment Hanmi Tamsulosin Capsule, and the erectile dysfunction drug Palpal Tab., while operating the raw-material API subsidiary Hanmi Fine Chemical Co. and the overseas subsidiary Beijing Hanmi Pharmaceutical Co. Hanmi Fine Chemical passed a 2006 FDA inspection of its sterile API division and, after completing a new API synthesis plant in 2007, obtained cGMP certifications from the US FDA, Germany's BSG, Australia's TGA, and Japan's PMDA, exporting to more than 40 countries; Beijing Hanmi sells around 20 products including the children's digestive aid Mamiai and the cough syrup Yitanjing, and launched the combination antihypertensive Meiyaping (marketed in Korea as Amosartan) in 2022.

Products & technology

  • AmosartanCombination antihypertensive
  • RosuzetCombination dyslipidemia treatment
  • EsomezolGERD treatment
  • Hanmi Tamsulosin CapsuleBPH treatment
  • Palpal Tab.Erectile dysfunction treatment
  • MamiaiChildren's digestive aid (sold in China)
  • YitanjingCough and phlegm remedy (sold in China)
  • MeiyapingCombination antihypertensive sold in China (marketed in Korea as Amosartan)

Regulatory approvals

data.go.kr

4 Orphan Drug designations · 2018–2025 / 465 Korean MFDS drug approvals · 1980–2026 / 5 Korean MFDS device approvals · 2012–2016

  • OrphanHM15421/GC1134A(피하주사제)2025-01-15
    Orphan Drug designation · in development20240176136
  • OrphanHM15912(주사제)2019-06-24
    Orphan Drug designation · in development20190050457
  • OrphanHM43239(경구제)2019-02-15
    Orphan Drug designation · in development20190000054
  • OrphanHM15136(주사제)2018-11-12
    Orphan Drug designation · in development20180279514
  • MFDS drugRolontis Auto-Injector Inj.2026-04-14
    Drug · Prescription · Approval202601086
  • MFDS drug.2026-04-10
    Drug · OTC · Notification202601034
  • MFDS drugEnzaron Soft Cap. 40mg2026-03-18
    Drug · Prescription · Approval202600792
  • MFDS drugHanmi Pentosan Cap.2026-03-17
    Drug · Prescription · Approval202600777
  • MFDS drugSulmum Chewable Tab.2026-02-27
    Drug · OTC · Notification202600604
  • MFDS drugOlotadine Eye Drop 0.2%2026-01-28
    Drug · Prescription · Approval202600249
  • MFDS drugAmosartan XQ Tab. 5/50/2.5/10mg2025-09-22
    Drug · Prescription · Approval202502506
  • MFDS drugAmosartan XQ Tab. 5/100/2.5/10mg2025-09-22
    Drug · Prescription · Approval202502507
Show 68 more
  • MFDS drugMaxibupen Cold Soft Cap.2025-08-06
    Drug · OTC · Notification202502043
  • MFDS drugMaxibupen Cough Soft Cap.2025-08-06
    Drug · OTC · Notification202502046
  • MFDS drugEmpalon Duo SR Tab. 5/1000mg2025-07-24
    Drug · Prescription · Approval202501902
  • MFDS drugEmpalon Duo SR Tab. 12.5/1000mg2025-07-24
    Drug · Prescription · Approval202501903
  • MFDS drugMaxibupen Nose Soft Cap.2025-07-22
    Drug · OTC · Notification202501849
  • MFDS drugSuspen Kids Syrup2025-07-17
    Drug · OTC · Notification202501821
  • MFDS drugEmpalon Duo SR tab. 25/1000mg2025-07-11
    Drug · Prescription · Approval202501759
  • MFDS drugEmpalon Duo SR tab. 10/1000mg2025-07-11
    Drug · Prescription · Approval202501760
  • MFDS drugAmoprel Tab. 1.67/16.67/4.17mg(Amlodipine, Losartan, Chlorthalidone)2025-05-30
    Drug · Prescription · Approval202501344
  • MFDS drugCal MD Tab.2025-05-28
    Drug · OTC · Notification202501318
  • MFDS drugHanmi Peramivir inj.2025-03-31
    Drug · Prescription · Approval202500751
  • MFDS drugMujonal Max Solution2025-03-10
    Drug · OTC · Approval202500523
  • MFDS drugHanmi Ginkgo Tablet 80mg2025-02-27
    Drug · OTC · Notification202500437
  • MFDS drugMagne B Speed Solution2024-12-19
    Drug · OTC · Notification202403017
  • MFDS drugHanmi Ginkgo Tablet 240mg2024-09-12
    Drug · OTC · Notification202402238
  • MFDS drugCo and Cool S Nasal Spray2024-05-14
    Drug · OTC · Notification202401177
  • MFDS drugNunenCool Eye Drop 0.6%2024-03-29
    Drug · OTC · Notification202400682
  • MFDS drugRelaxdam Tab.2024-02-19
    Drug · OTC · Notification202400351
  • MFDS drugAbiterone Duo Tab. 500/2.5mg(Abiraterone, Prednisolone)2024-02-14
    Drug · Prescription · Approval202400316
  • MFDS drugLinaglomet XR Tab. 5/1000mg(Linagliptin,Metformin)2024-01-24
    Drug · Prescription · Approval202400188
  • MFDS drugLinaglomet XR Tab. 2.5/1000mg(Linagliptin,Metformin)2024-01-24
    Drug · Prescription · Approval202400189
  • MFDS drugRaspirin Cap. 100/5mg(Aspirin, Rabeprazole)2023-10-30
    Drug · Prescription · Approval202303032
  • MFDS drugOmest Soft Capsule 5/1000mg2023-08-30
    Drug · Prescription · Approval202302554
  • MFDS drugOmest Soft Capsule 10/1000mg2023-08-30
    Drug · Prescription · Approval202302555
  • MFDS drugNunenQ Eye Drop2023-08-22
    Drug · OTC · Notification202302477
  • MFDS drugAbiteron Tab. 500mg(Abiraterone Acetate(micronized))2023-06-14
    Drug · Prescription · Approval202301839
  • MFDS drugSildapa M SR Tab. 5/50/1000mg2023-05-22
    Drug · Prescription · Approval202301623
  • MFDS drugSildapa M SR Tab. 5/50/500mg2023-05-22
    Drug · Prescription · Approval202301624
  • MFDS drugSildapa M SR Tab. 5/50/750mg2023-05-22
    Drug · Prescription · Approval202301625
  • MFDS drugClosartan Tab. 50/6.25mg(Losartan Potassium/Chlorthalidone)2023-04-28
    Drug · Prescription · Approval202301412
  • MFDS drugEdoxban Tab. 30mg2023-04-12
    Drug · Prescription · Approval202301209
  • MFDS drugEdoxban Tab. 15mg2023-04-12
    Drug · Prescription · Approval202301210
  • MFDS drugNocotine Tab. 1mg2023-03-31
    Drug · Prescription · Approval202301089
  • MFDS drugNocotine Tab. 0.5mg2023-03-31
    Drug · Prescription · Approval202301090
  • MFDS drugSpeedpain Easy Soft Cap.2023-02-09
    Drug · OTC · Notification202300495
  • MFDS drugNicegoline tab. 10mg2023-01-31
    Drug · Prescription · Approval202300405
  • MFDS drugNicegoline tab. 30mg2023-01-31
    Drug · Prescription · Approval202300406
  • MFDS drugLevoxacin Eye Drops 1.5%2023-01-25
    Drug · Prescription · Approval202300326
  • MFDS drugEdoxban Tab. 60mg2022-12-05
    Drug · Prescription · Approval202204362
  • MFDS drugSildapa Tab. 10/100mg2022-11-04
    Drug · Prescription · Approval202204006
  • MFDS drugEsomezol DR SR Cap. 10mg(Esomeprazole magnesium trihydrate)2022-09-30
    Drug · Prescription · Approval202203716
  • MFDS drugHanmi Bromfenac Sodium Hydrate Eye Drops(Single-use)(tentatively named)2022-09-07
    Drug · Prescription · Approval202203503
  • MFDS drugDapalon Duo SR tab. 5/500mg2022-06-15
    Drug · Prescription · Approval202202497
  • MFDS drugDapalon Duo SR tab. 5/1000mg2022-06-15
    Drug · Prescription · Approval202202498
  • MFDS drugDapalon Duo SR tab. 10/500mg2022-06-15
    Drug · Prescription · Approval202202499
  • MFDS drugDapalon Duo SR tab. 10/1000mg2022-06-15
    Drug · Prescription · Approval202202500
  • MFDS drugClosartan Tab. 100/12.5mg2022-05-31
    Drug · Prescription · Approval202202296
  • MFDS drugClosartan Tab. 50/12.5mg2022-05-31
    Drug · Prescription · Approval202202297
  • MFDS drugEsomezol plus Tab. 20/350mg2022-03-21
    Drug · Prescription · Approval202201119
  • MFDS drugEsomezol plus Tab. 40/350mg2021-10-22
    Drug · Prescription · Approval202107076
  • MFDS drugRosuzet Tab. 10/2.5mg2021-09-24
    Drug · Prescription · Approval202106637
  • MFDS drugSuvast Tab. 2.5mg2021-08-17
    Drug · Prescription · Approval202105987
  • MFDS drugEmpalon Tab. 25mg2021-08-11
    Drug · Prescription · Approval202105848
  • MFDS drugEmpalon Tab. 10mg2021-08-11
    Drug · Prescription · Approval202105849
  • MFDS drugVildaglemet Tab. 50/500mg2021-07-13
    Drug · Prescription · Approval202105309
  • MFDS drugVildaglemet Tab. 50/1000mg2021-07-13
    Drug · Prescription · Approval202105310
  • MFDS drugVildaglemet Tab. 50/850mg2021-07-13
    Drug · Prescription · Approval202105311
  • MFDS drugGliterol Inhalation Cap. 110/50mcgRevoked2021-06-08
    Drug · Prescription · Approval202104446
  • MFDS drugRolontis Prefilled Syringe Inj.2021-03-18
    Drug · Prescription · Approval202102429
  • MFDS drugVildagle Tab. 50mg2021-02-10
    Drug · Prescription · Approval202101225
  • MFDS drugMujonal Power Spray SolutionRevoked2020-11-19
    Drug · OTC · Notification202008020
  • MFDS drugAmosartan XQ Tab. 5/50/5/10mg2020-11-09
    Drug · Prescription · Approval202007691
  • MFDS drugAmosartan XQ Tab. 5/50/20/10mg2020-11-09
    Drug · Prescription · Approval202007692
  • MFDS drugAmosartan XQ Tab. 5/50/10/10mg2020-11-09
    Drug · Prescription · Approval202007693
  • MFDS drugAmosartan XQ Tab. 5/100/5/10mg2020-11-09
    Drug · Prescription · Approval202007694
  • MFDS drugAmosartan XQ Tab. 5/100/20/10mg2020-11-09
    Drug · Prescription · Approval202007695
  • MFDS drugAmosartan XQ Tab. 5/100/10/10mg2020-11-09
    Drug · Prescription · Approval202007696
  • MFDS drugSoranib Tab. 200mg2020-10-29
    Drug · Prescription · Approval202007416

Showing the 80 most recent of 474 records.

Clinical trials

data.go.kr

190 MFDS clinical trial authorisations · 2012–2026 (Phase 1 92 · Bioequivalence 47 · Phase 3 33 · Phase 2 17 · Phase 1/2 1)

  • Phase 3HCP1803-42026-05-29

    11 trial sites

  • BioequivalenceHCP1004-A2026-04-21

    2 trial sites

  • BioequivalenceHCP1004-A2026-04-20

    2 trial sites

  • Phase 1HIP24042026-01-26

    2 trial sites

  • Phase 3HM11260C2026-01-21

    14 trial sites

  • Phase 2HM95573정2026-01-05

    13 trial sites

  • Phase 1HIP25032025-12-03

    1 trial site

  • BioequivalenceHGP25012025-09-10

    2 trial sites

  • Phase 1HCP23052025-06-11

    1 trial site

  • BioequivalenceHGP24032024-12-26

    2 trial sites

  • BioequivalenceHGP24072024-12-10

    2 trial sites

  • Phase 1HM163902024-11-07

    5 trial sites

Show 68 more
  • Phase 3HCP1004-A2024-08-09

    29 trial sites

  • Phase 1HCP23052024-07-02

    1 trial site

  • Phase 2HM151362024-04-24

    2 trial sites

  • Phase 1HCP23032024-03-20

    2 trial sites

  • Phase 1HCP23032024-03-19

    2 trial sites

  • Phase 3HCP1803-42024-02-05

    10 trial sites

  • Phase 3HM11260C2023-10-23

    22 trial sites

  • Phase 1BH31202023-08-18

    5 trial sites

  • Phase 3HGP23042023-03-16

    54 trial sites

  • Phase 1HCP22032023-03-08

    1 trial site

  • Phase 1HCP22012023-02-07

    1 trial site

  • Phase 1HCP1803-42023-01-26

    1 trial site

  • BioequivalenceHGP22062022-12-19

    2 trial sites

  • Phase 3HIP06122022-10-31

    55 trial sites

  • BioequivalenceHGP07062022-10-05

    2 trial sites

  • BioequivalenceHGP22032022-09-06

    2 trial sites

  • Phase 1HCP22022022-09-06

    1 trial site

  • Phase 1HCP22022022-08-31

    1 trial site

  • Phase 1HM976622022-08-30

    5 trial sites

  • Phase 1HCP22022022-07-14

    4 trial sites

  • Phase 1HCP19042022-05-20

    1 trial site

  • Phase 3HCP21022022-04-25

    55 trial sites

  • BioequivalenceHGP21012021-12-21

    1 trial site

  • Phase 3HCP1803-42021-11-30

    13 trial sites

  • BioequivalenceHGP21022021-10-28

    1 trial site

  • Phase 2HM159122021-10-08

    1 trial site

  • Phase 1HCP20012021-08-23

    1 trial site

  • Phase 2HM152112021-08-12

    12 trial sites

  • Phase 3HCP19042021-08-10

    18 trial sites

  • Phase 3HIP21012021-07-27

    44 trial sites

  • Phase 1HIP21052021-06-29

    2 trial sites

  • Phase 1HCP19022021-04-12

    2 trial sites

  • Phase 1HIP21012021-03-30

    1 trial site

  • Phase 2FLX475정2021-02-08

    10 trial sites

  • Phase 1HCP19042021-01-27

    1 trial site

  • Phase 2HCP1803-42021-01-11

    11 trial sites

  • Phase 1HIP20012020-10-08

    1 trial site

  • Phase 1HCP19032020-09-04

    2 trial sites

  • Phase 3HCP19042020-08-11

    17 trial sites

  • Phase 3HCP19042020-08-04

    18 trial sites

  • Phase 3HCP19032020-03-30

    31 trial sites

  • Phase 1HIP18022020-02-19

    2 trial sites

  • Phase 1HIP16012019-12-17

    2 trial sites

  • BioequivalenceHGP14072019-09-30

    2 trial sites

  • Phase 1HM159122019-07-08

    1 trial site

  • Phase 1HCP17042019-05-20

    2 trial sites

  • Phase 3HIP16012019-04-16

    15 trial sites

  • Phase 2포지오티닙정(포지오티닙염산염)2019-04-04

    5 trial sites

  • BioequivalenceHGP17012019-01-25

    2 trial sites

  • Phase 1HGP16022019-01-23

    1 trial site

  • Phase 1HIP16012019-01-23

    2 trial sites

  • Phase 1HCP18012019-01-04

    1 trial site

  • Phase 3HCP17012019-01-02

    13 trial sites

  • Phase 2HCP1803-42018-12-14

    9 trial sites

  • BioequivalenceHGP17012018-12-11

    2 trial sites

  • Phase 1HIP18012018-11-27

    1 trial site

  • Phase 1HIP17012018-10-15

    1 trial site

  • Phase 1HCP17042018-10-15

    1 trial site

  • Phase 3HIP16012018-09-04

    20 trial sites

  • Phase 1HM151362018-09-04

    1 trial site

  • Phase 3HCP11022018-08-31

    15 trial sites

  • Phase 1HCP17012018-08-24

    1 trial site

  • Phase 1HCP17032018-08-16

    1 trial site

  • Phase 1HCP14022018-06-01

    1 trial site

  • Bioequivalence아섹정(아세클로페낙)2018-03-29

    2 trial sites

  • Phase 1HCP17012018-03-26

    1 trial site

  • Phase 1구구탐스캡슐(HCP1303)2018-02-01

    1 trial site

  • Phase 1HIP16012018-01-24

    1 trial site

Showing the 80 most recent of 190 records.

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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.

IL DONG PHARMACEUTICAL CO., LTD.2 shared

Founded and listed on the KOSPI in 2016, Il Dong Pharmaceutical manufactures products including the Aronamin vitamin line.

BNC KOREA, Inc.1 shared

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

ChoA Pharmaceutical Co., LTD.1 shared

Founded in 1996 and listed on KOSDAQ in 1999, ChoA Pharmaceutical is an OTC-focused drugmaker exporting to 23 countries worldwide.

DongKookPharmaceuticalCo.,Ltd.1 shared

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

Hanmi Science Co.,Ltd1 shared

KOSPI-listed operating holding company of the Hanmi Pharm group, also running healthcare and pharmaceutical wholesale businesses.

JW SHINYAK CORPORATION1 shared

A pharmaceutical company supplying antifungal and urology drugs to clinics, co-marketing original drugs together with JW Pharmaceutical.

KYUNG NAM PHARM.CO.,LTD.1 shared

Founded in 1998, Kyungnam Pharm is a pharmaceutical and health-food company known for the vitamin brand Lemona and placenta drink Jahasaengryeok.

NUON CO., LTD.1 shared

KOSDAQ-listed healthcare company selling the Cissus weight-management ingredient and Sallimbaekseo household products.

OSANG HEALTHCARE CO.,LTD.1 shared

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

Samyang Biopharm Corporation1 shared

Founded and KOSPI-listed in 2025, Samyang Biopharm develops medical devices, pharmaceuticals, and new drug candidates.

Sugentech, Inc.1 shared

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

Wonbiogen Co.,Ltd.1 shared

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

Sources and updates

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

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