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Pharma & CDMOKOSDAQ 330350227 approvals66 trials

Withus Pharmaceutical. Co., LTD

Official website

Founded in 2004 and listed on KOSDAQ in 2020, Withus Pharmaceutical is a generic and CMO drugmaker focused on cardiovascular medicines.

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Products & technology

  • 아토렌정Hyperlipidemia treatment (atorvastatin, Lipitor generic)
  • 피도그린정Antiatherosclerotic agent
  • 브이디핀정Antihypertensive
  • 텔미사르탄Antihypertensive (pelletized formulation)

Regulatory approvals

data.go.kr

227 Korean MFDS drug approvals · 1988–2026

  • MFDS drugRovzet ODT. 10/20mg2026-06-30
    Drug · Prescription · Approval202601885
  • MFDS drugRovzet ODT. 10/10mg2026-06-30
    Drug · Prescription · Approval202601886
  • MFDS drugRovzet ODT. 10/5mg2026-06-30
    Drug · Prescription · Approval202601887
  • MFDS drugPranuka Tab. 50mg2026-06-29
    Drug · Prescription · Approval202601848
  • MFDS drugForxizin Tab. 10mg2026-04-01
    Drug · Prescription · Approval202600928
  • MFDS drugForxizin Tab. 5mg2026-04-01
    Drug · Prescription · Approval202600929
  • MFDS drugV-dipine Tab. 2.5/80mg2026-02-24
    Drug · Prescription · Approval202600553
  • MFDS drugMantini Tab. 5mg2025-12-05
    Drug · Prescription · Approval202503180
  • MFDS drugVitamD soft capsule 0.5mcg(Alfacalcidol)2025-10-01
    Drug · OTC · Notification202502605
  • MFDS drugWITHUCAB Tablet2025-07-14
    Drug · Prescription · Approval202501770
  • MFDS drugWipide SR tab. 150mg2025-06-11
    Drug · Prescription · Approval202501432
  • MFDS drugTasfeno Cap.2025-04-30
    Drug · Prescription · Approval202501059
Show 68 more
  • MFDS drugMantini Tab. 20mg2025-04-16
    Drug · Prescription · Approval202500919
  • MFDS drugMirto Tab. 20mg2025-03-06
    Drug · Prescription · Approval202500502
  • MFDS drugGinbiloba Tab. 240mg2024-10-24
    Drug · OTC · Notification202402519
  • MFDS drugCecl-One MR Tab. 375mg2024-03-27
    Drug · Prescription · Approval202400678
  • MFDS drugWicer Tab. 30mg2024-02-29
    Drug · Prescription · Approval202400437
  • MFDS drugWidiance Duo Tab. 12.5/1000mg2023-09-13
    Drug · Prescription · Approval202302748
  • MFDS drugWidiance Duo Tab 12.5/850mg2023-09-13
    Drug · Prescription · Approval202302749
  • MFDS drugWidiance Duo Tab 12.5/500mg2023-09-13
    Drug · Prescription · Approval202302750
  • MFDS drugForximet XR tab. 5/500mg2022-11-10
    Drug · Prescription · Approval202204063
  • MFDS drugForximet XR tab. 10/500mgRevoked2022-11-10
    Drug · Prescription · Approval202204064
  • MFDS drugWidiance Duo Tab. 5/850mg2022-04-04
    Drug · Prescription · Approval202201370
  • MFDS drugWidiance Duo Tab. 5/1000mg2022-04-04
    Drug · Prescription · Approval202201371
  • MFDS drugWidiance Duo Tab. 5/500mg2022-04-04
    Drug · Prescription · Approval202201372
  • MFDS drugForxirizin Tab.2022-03-11
    Drug · Prescription · Approval202201028
  • MFDS drugEsliptin-M Tab. 50/1000mg2022-03-02
    Drug · Prescription · Approval202200906
  • MFDS drugEsliptin-D Tab. 10/100mg2022-01-28
    Drug · Prescription · Approval202200491
  • MFDS drugEsliptin-M Tab. 50/850mg2022-01-20
    Drug · Prescription · Approval202200333
  • MFDS drugEsliptin-M Tab. 50/500mg2022-01-20
    Drug · Prescription · Approval202200334
  • MFDS drugWirelto Tab. 2.5mg2021-12-29
    Drug · Prescription · Approval202108132
  • MFDS drugRegaba Tab. 25mg2021-12-20
    Drug · Prescription · Approval202108022
  • MFDS drugWithuGood ODF 20mg2021-10-25
    Drug · Prescription · Approval202107093
  • MFDS drugWithuGood ODF 10mg2021-10-25
    Drug · Prescription · Approval202107094
  • MFDS drugForximet XR tab. 10/1000mg2021-10-20
    Drug · Prescription · Approval202107048
  • MFDS drugForximet XR tab. 5/1000mg2021-10-20
    Drug · Prescription · Approval202107049
  • MFDS drugEsrazoleduo20/800mg2021-06-18
    Drug · Prescription · Approval202104746
  • MFDS drugDurotel tab. 80/20mg2021-06-14
    Drug · Prescription · Approval202104525
  • MFDS drugDurotel tab. 80/10mg2021-06-14
    Drug · Prescription · Approval202104526
  • MFDS drugTastin Tab. 4mg2021-04-29
    Drug · Prescription · Approval202103491
  • MFDS drugDurotel tab. 40/20mg2021-04-22
    Drug · Prescription · Approval202103315
  • MFDS drugDurotel tab. 40/10mg2021-04-22
    Drug · Prescription · Approval202103316
  • MFDS drugDurotel Tab. 40/5mg2021-04-22
    Drug · Prescription · Approval202103317
  • MFDS drugWithupezil Tab. 23mg2021-04-05
    Drug · Prescription · Approval202102936
  • MFDS drugTastin Tab. 1mg2021-03-31
    Drug · Prescription · Approval202102817
  • MFDS drugWidiance Tab. 10mg2021-03-05
    Drug · Prescription · Approval202102099
  • MFDS drugWidiance Tab. 25mg2021-03-05
    Drug · Prescription · Approval202102100
  • MFDS drugButimerin Tab.Revoked2021-02-26
    Drug · OTC · Notification202101918
  • MFDS drugAvazet Tab. 10/40mg2021-02-25
    Drug · Prescription · Approval202101873
  • MFDS drugAvazet Tab. 10/20mg2021-02-18
    Drug · Prescription · Approval202101393
  • MFDS drugAvazet Tab. 10/10mg2021-02-18
    Drug · Prescription · Approval202101394
  • MFDS drugWitofanib Tab. 5mgRevoked2021-01-07
    Drug · Prescription · Approval202100141
  • MFDS drugSonperi SR Tab.Revoked2020-06-23
    Drug · Prescription · Approval202004617
  • MFDS drugForxizin Tab. 10mgRevoked2020-06-17
    Drug · Prescription · Approval202004449
  • MFDS drugEsliptin Tab. 100mg2020-05-29
    Drug · Prescription · Approval202004028
  • MFDS drugEsliptin Tab. 50mg2020-05-29
    Drug · Prescription · Approval202004029
  • MFDS drugEsliptin Tab. 25mg2020-05-29
    Drug · Prescription · Approval202004030
  • MFDS drugOlmerosu Tab. 20/20mg2020-05-28
    Drug · Prescription · Approval202003956
  • MFDS drugOlmerosu Tab. 20/10mg2020-05-28
    Drug · Prescription · Approval202003957
  • MFDS drugOlmerosu Tab. 20/5mg2020-05-28
    Drug · Prescription · Approval202003958
  • MFDS drugU-penil Cap.2020-05-27
    Drug · Prescription · Approval202003924
  • MFDS drugIbansan Inj.2020-05-11
    Drug · Prescription · Notification202003406
  • MFDS drugWithupentin Cap. 300mg2020-04-29
    Drug · Prescription · Approval202003239
  • MFDS drugWithupentin Cap. 100mg2020-04-29
    Drug · Prescription · Approval202003240
  • MFDS drugGaspin SR Tab. 15mg2020-04-24
    Drug · Prescription · Approval202002987
  • MFDS drugAtoren Tab. 40mg2020-04-10
    Drug · Prescription · Approval202002540
  • MFDS drugRegaba Tab. 75mg2020-03-31
    Drug · Prescription · Approval202002264
  • MFDS drugRegaba Tab. 50mg2020-03-31
    Drug · Prescription · Approval202002265
  • MFDS drugRegaba Tab. 150mg2020-03-31
    Drug · Prescription · Approval202002266
  • MFDS drugWiprozil Tab.2020-03-25
    Drug · Prescription · Approval202002098
  • MFDS drugV-dio Tab. 80mg2020-03-19
    Drug · Prescription · Approval202001920
  • MFDS drugV-dio Tab. 160mg2020-03-19
    Drug · Prescription · Approval202001921
  • MFDS drugSimva-V Tab.Revoked2020-03-19
    Drug · Prescription · Approval202001928
  • MFDS drugWithus Lafutidine Tab. 10mg2020-03-03
    Drug · Prescription · Approval202001488
  • MFDS drugOlmepine Tab. 5/20mg2020-02-21
    Drug · Prescription · Approval202001260
  • MFDS drugOlmepine Tab. 5/40mg2020-02-21
    Drug · Prescription · Approval202001261
  • MFDS drugOlmepine Tab. 10/40mg2020-02-21
    Drug · Prescription · Approval202001262
  • MFDS drugSarpol SR Tab. 300mg2020-02-20
    Drug · Prescription · Approval202001222
  • MFDS drugCetiaxone Inj. 2g2020-01-07
    Drug · Prescription · Notification202000104
  • MFDS drugCetiaxone Inj. 0.5gRevoked2020-01-07
    Drug · Prescription · Notification202000103

Showing the 80 most recent of 227 records.

Clinical trials

data.go.kr

66 MFDS clinical trial authorisations · 2012–2026 (Bioequivalence 62 · Phase 1 4)

  • Bioequivalence트윈플러스정80/10mg2026-03-25

    2 trial sites

  • BioequivalenceWU-24001T2025-11-24

    2 trial sites

  • Bioequivalence타스젯정4/10밀리그램(피타바스타틴칼슘,에제티미브)2025-10-28

    2 trial sites

  • Phase 1포시메트서방정10/1000밀리그램2025-07-21

    2 trial sites

  • BioequivalenceWTU-1020T2025-05-26

    2 trial sites

  • Bioequivalence에스라졸정40밀리그램(에스오메프라졸마그네슘삼수화물)2025-04-15

    2 trial sites

  • Phase 1포시메트서방정10/1000밀리그램2025-01-06

    2 trial sites

  • BioequivalenceWU-24001T2024-12-04

    2 trial sites

  • Bioequivalence메트포민서방정(메트포르민염산염)2024-07-24

    2 trial sites

  • BioequivalenceWU-22004T2024-04-23

    2 trial sites

  • BioequivalenceWU-22004T2024-04-23

    2 trial sites

  • Bioequivalence메트포민서방정(메트포르민염산염)2024-03-29

    2 trial sites

Show 54 more
  • Phase 1포시진정10밀리그램2024-03-28

    2 trial sites

  • Bioequivalence트윈플러스정80/10mg2024-01-16

    2 trial sites

  • Bioequivalence아토렌정40밀리그램(아토르바스타틴칼슘삼수화물)2023-12-28

    2 trial sites

  • Phase 1W-2142023-12-01

    2 trial sites

  • BioequivalenceW-215T2023-11-21

    2 trial sites

  • Bioequivalence레이프라정20밀리그램(라베프라졸나트륨)2023-11-21

    2 trial sites

  • Bioequivalence위더스세파클러서방정375밀리그램(세파클러수화물)2023-04-24

    2 trial sites

  • BioequivalenceWU-22004T2023-03-17

    2 trial sites

  • BioequivalenceWU-22004T2023-03-09

    2 trial sites

  • Bioequivalence위더스세파클러서방정375밀리그램(세파클러수화물)2022-12-22

    2 trial sites

  • Bioequivalence레프로진정(레보드로프로피진)2022-12-19

    2 trial sites

  • Bioequivalence레티라진정(레보세티리진염산염)2022-12-14

    2 trial sites

  • Bioequivalence위피드정100밀리그램(레바미피드)2022-05-03

    2 trial sites

  • Bioequivalence가스핀정(모사프리드시트르산염수화물)2022-02-25

    2 trial sites

  • Bioequivalence에스라졸정40밀리그램(에스오메프라졸마그네슘삼수화물)2022-01-24

    2 trial sites

  • Bioequivalence위피드정100밀리그램(레바미피드)2021-11-08

    2 trial sites

  • Bioequivalence위더콕스캡슐200밀리그램(세레콕시브)2021-10-07

    2 trial sites

  • Bioequivalence세로아핀정100mg(쿠에티아핀푸마르산염)2021-09-02

    2 trial sites

  • Bioequivalence레이프라정20밀리그램(라베프라졸나트륨)2021-07-30

    2 trial sites

  • Bioequivalence아스틴정(아젤라스틴염산염)2021-07-26

    2 trial sites

  • Bioequivalence위더스파모티딘정20mg2021-07-16

    2 trial sites

  • Bioequivalence세악틸정(세푸록심악세틸)2021-07-12

    2 trial sites

  • Bioequivalence위더스세파클러서방정375밀리그램(세파클러수화물)2021-05-11

    2 trial sites

  • Bioequivalence세프포정(세프포독심프록세틸)2021-03-29

    2 trial sites

  • Bioequivalence에스라졸정40밀리그램(에스오메프라졸마그네슘삼수화물)2021-03-26

    2 trial sites

  • Bioequivalence위프로질정(세프프로질수화물)2021-03-25

    2 trial sites

  • Bioequivalence테르나정(테르비나핀염산염)2021-03-05

    2 trial sites

  • Bioequivalence타록시드정100밀리그람(오플록사신)2021-02-23

    2 trial sites

  • Bioequivalence위더세프캡슐(세파드록실수화물)2021-01-21

    2 trial sites

  • Bioequivalence아레온정10밀리그램(에피나스틴염산염)2020-11-05

    2 trial sites

  • Bioequivalence팜시스정250mg(팜시클로비르)2020-10-08

    2 trial sites

  • Bioequivalence소로펜정2020-07-09

    2 trial sites

  • Bioequivalence아토렌정20밀리그램(아토르바스타틴칼슘삼수화물)2020-06-11

    2 trial sites

  • Bioequivalence듀로텔정 80/202020-03-17

    2 trial sites

  • Bioequivalence아바젯정10/20mg2019-11-25

    2 trial sites

  • Bioequivalence위피드정100밀리그램(레바미피드)2019-09-30

    2 trial sites

  • Bioequivalence피도그린정75mg(클로피도그렐황산염)2019-09-27

    2 trial sites

  • Bioequivalence소로펜정2019-09-18

    2 trial sites

  • Bioequivalence듀로텔정 40/202019-09-06

    2 trial sites

  • Bioequivalence레가바정75밀리그램(프레가발린)2019-03-06

    2 trial sites

  • Bioequivalence브이디핀정10/160mg2016-06-08

    2 trial sites

  • Bioequivalence위더페질정10밀리그램(도네페질염산염)2016-03-14

    2 trial sites

  • Bioequivalence네오브론캡슐(아세브로필린)2015-10-30

    1 trial site

  • Bioequivalence로수브이정10mg(로수바스타틴칼슘)2015-10-29

    2 trial sites

  • Bioequivalence트윈플러스정80/5mg2015-10-16

    2 trial sites

  • Bioequivalence트루렌정 4밀리그램(실로도신)2015-03-18

    2 trial sites

  • Bioequivalence로우딘정5mg(암로디핀베실산염)2015-02-13

    2 trial sites

  • Bioequivalence위더스세프라딘캡슐500mg(세프라딘수화물)2014-04-28

    2 trial sites

  • Bioequivalence카베올정(카르베딜롤)2013-10-29

    2 trial sites

  • Bioequivalence미르토플러스정80/12.52013-05-15

    2 trial sites

  • Bioequivalence미르토정80mg(텔미사르탄)2013-02-28

    2 trial sites

  • Bioequivalence지스톨정(미소프로스톨)2013-02-01

    2 trial sites

  • Bioequivalence로바토정5mg/20mg2012-12-10

    2 trial sites

  • Bioequivalence솔리신정10밀리그램(솔리페나신숙신산염)(가칭)2012-09-17

    2 trial sites

R&D and key agreements

Source: DART corporate disclosure

IVL-DrugFluidicTM 두타스테리드 전립선비대증치료제 · 전립선비대증 · Licensed in from Inventage Lab with worldwide rights to clinical development, approval, manufacturing, and commercialization.

에페리손염산염 서방정 안정성 개선 기술 · 근골격계 · 특허출원(2019년 4월, 만료 2039년 4월) · Filed a patent in April 2019 for a stability-improvement method for a sustained-release eperisone hydrochloride tablet.

이중정 기반 순환기·근골격용제 파이프라인 · 순환기계·근골격계 · Began developing bilayer-tablet-based generic drugs in February 2017.

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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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