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Pharma & CDMOKOSPI 003000Orphan Drug226 approvals16 trials

BUKWANG PHARMACEUTICAL IND CO.,LTD

Official website

Founded 1960, KOSPI-listed 1988, Bukwang Pharmaceutical makes Dexid, Levovir, and Latuda, and licensed MLR-1023 to Melior and Biodexa.

As of 2026-10-08, BUKWANG PHARMACEUTICAL IND CO.,LTD has 224 Korean MFDS drug approvals, 1 PubMed-indexed paper on record (counted by the MAA Company Index from its own matching of public databases).

Price

Change

Market cap

Business overview

Source: DART corporate disclosure

Bukwang Pharmaceutical was founded on October 17, 1960 and listed on the KOSPI on August 5, 1988. It manufactures and sells pharmaceuticals and quasi-drugs including Dexid, Levovir, Latuda, Legalon, Thioctacid, and Synthyroid, and runs R&D programs such as CP-012. Consolidated revenue reached KRW 200.7 billion (up ~25% year-on-year) and operating profit rose 784% to KRW 14.2 billion, while it licensed out MLR-1023 to Melior Pharmaceuticals and Biodexa Pharmaceuticals.

Products & technology

  • Levovir (Clevudine)Chronic hepatitis B treatment
  • Dexid (R-thioctic acid tromethamine)Diabetic neuropathy treatment
  • LatudaSchizophrenia, bipolar depression treatment

Regulatory approvals

data.go.kr

2 Orphan Drug designations · 2016–2017 / 224 Korean MFDS drug approvals · 1963–2026

  • OrphanJM-0102017-01-04
    Orphan Drug designation · in development20160183139
  • Orphan아파티닙메실레이트정제2016-02-03
    Orphan Drug designation · in development20150193669
  • MFDS drugErozet Tab. 1/10mg2026-04-24
    Drug · Prescription · Approval202601207
  • MFDS drugLodivan Tab. 2.5/80mg (Amlodipine Besylate, Valsartan)2026-02-25
    Drug · Prescription · Approval202600576
  • MFDS drugBukwang Brifil Tab. 25 mg2025-09-19
    Drug · Prescription · Approval202502485
  • MFDS drugBukwang Brifil Tab. 10 mg2025-09-19
    Drug · Prescription · Approval202502486
  • MFDS drugBukwang Brifil Tab. 50 mg2025-09-19
    Drug · Prescription · Approval202502487
  • MFDS drugBukwang Brifil Tab. 100 mg2025-09-19
    Drug · Prescription · Approval202502488
  • MFDS drugAriplus tablet 10/20mg2024-12-27
    Drug · Prescription · Approval202403090
  • MFDS drugLATUDA 120mg tablets2023-11-23
    Drug · Prescription · Approval202303204
  • MFDS drugLATUDA 80mg tablets2023-11-23
    Drug · Prescription · Approval202303205
  • MFDS drugLATUDA 60mg tablets2023-11-23
    Drug · Prescription · Approval202303206
Show 68 more
  • MFDS drugLATUDA 20mg tablets2023-11-23
    Drug · Prescription · Approval202303207
  • MFDS drugLATUDA 40mg tablets2023-11-23
    Drug · Prescription · Approval202303208
  • MFDS drugMegabraynon Capsule2023-11-16
    Drug · OTC · Notification202303156
  • MFDS drugTacenol Kids Syrup(Acetaminophen)2023-09-26
    Drug · OTC · Notification202302828
  • MFDS drugBengdelong S Syrup2023-07-24
    Drug · OTC · Notification202302217
  • MFDS drugTacenol Ibu Soft Cap 400 mg(Ibuprofen)2023-05-11
    Drug · OTC · Notification202301519
  • MFDS drugSaponal S GranuleRevoked2023-05-03
    Drug · OTC · Notification202301442
  • MFDS drugTacenol Cold Syrup2023-03-31
    Drug · OTC · Notification202301092
  • MFDS drugTacenolen hanbang Soft Ext.2023-01-16
    Drug · OTC · Notification202300264
  • MFDS drugVita Angel Chewable Tab.2022-12-27
    Drug · OTC · Notification202204643
  • MFDS drugTacenol Cold Cap.2022-12-23
    Drug · OTC · Notification202204622
  • MFDS drugMGMax Plus B Soft Cap.2022-12-09
    Drug · OTC · Notification202204454
  • MFDS drugMGMax Speed Solution2022-12-08
    Drug · OTC · Notification202204434
  • MFDS drugZaledeep Capsule 5mg(zaleplon)2022-06-29
    Drug · Prescription · Approval202202678
  • MFDS drugZaledeep Capsule 10mg(zaleplon)2022-06-29
    Drug · Prescription · Approval202202679
  • MFDS drugBukwang Ascorbic Acid Tab.500mg2022-06-20
    Drug · OTC · Approval202202571
  • MFDS drugTacenol Tab. 160mg2022-04-27
    Drug · OTC · Notification202201721
  • MFDS drugOzanex Cream2021-12-10
    Drug · Prescription · Approval202107880
  • MFDS drugHardcal C Plus Tablet2021-10-07
    Drug · OTC · Notification202106791
  • MFDS drugBudian Tab. 25mg2021-07-23
    Drug · Prescription · Approval202105536
  • MFDS drugBudian Tab. 10mg2021-07-23
    Drug · Prescription · Approval202105537
  • MFDS drugWisogen Tablet2021-03-15
    Drug · OTC · Notification202102295
  • MFDS drugNaevaren Q Sol.2021-03-09
    Drug · OTC · Notification202102183
  • MFDS drugBukwang Methimazole Tablet 2.5mg2021-01-20
    Drug · Prescription · Approval202100592
  • MFDS drugZemple D Injection2020-11-30
    Drug · Prescription · Approval202008320
  • MFDS drugCircaledeep PR Tab. 2mg (Melatonin)2020-09-22
    Drug · Prescription · Approval202006550
  • MFDS drugFamertidine Tab.2020-08-25
    Drug · OTC · Notification202005998
  • MFDS drugBukwang kyungokgo2020-05-22
    Drug · OTC · Notification202003751
  • MFDS drugBukwang Midazolam Injection 15mg/3mL(for export)2020-04-13
    Drug · Prescription · Approval202002585
  • MFDS drugCotrina Cap.2020-04-06
    Drug · OTC · Notification202002383
  • MFDS drugMG Max Plus Soft Cap.Revoked2020-03-02
    Drug · OTC · Notification202001470
  • MFDS drugActiby Tab.2019-12-16
    Drug · OTC · Notification201908441
  • MFDS drugSynthyroid Tablet 0.025mg2019-05-21
    Drug · Prescription · Approval201903264
  • MFDS drugSynthyroid Tablet 0.0375mg2019-05-07
    Drug · Prescription · Approval201902912
  • MFDS drugNavelbine Soft Capsule 20mgRevoked2019-02-15
    Drug · Prescription · Approval201900960
  • MFDS drugNavelbine Soft Capsule 30mgRevoked2019-02-15
    Drug · Prescription · Approval201900961
  • MFDS drugSynthyroid Tablet 0.112mg2019-01-10
    Drug · Prescription · Approval201900107
  • MFDS drugSynthyroid Tablet 0.2mg2018-10-26
    Drug · Prescription · Approval201804237
  • MFDS drugSaponal GranuleRevoked2018-06-11
    Drug · OTC · Notification201802402
  • MFDS drugLegaliver 350 Soft Cap.2018-03-30
    Drug · OTC · Notification201801423
  • MFDS drugDermomedi Q Solution2018-02-27
    Drug · OTC · Notification201800949
  • MFDS drugTacenol 8 hours ER Tablet 325mg2018-01-30
    Drug · OTC · Approval201800567
  • MFDS drugHexamedine Solution 0.12%2017-12-11
    Drug · OTC · Notification201708285
  • MFDS drugLegadex Cap.2017-09-18
    Drug · Prescription · Approval201707113
  • MFDS drugFreead Tablet2017-08-11
    Drug · Prescription · Approval201706556
  • MFDS drugAlaxyl Soft Syrup2017-08-09
    Drug · OTC · Notification201706514
  • MFDS drugCentella Tab.2017-06-19
    Drug · OTC · Notification201703991
  • MFDS drugFerroba Momscare Tab.2016-11-10
    Drug · OTC · Notification201606593
  • MFDS drugTelmistan Tablet 40/5mg2016-09-30
    Drug · Prescription · Approval201605819
  • MFDS drugTelmistan Tablet 80/5mg2016-09-30
    Drug · Prescription · Approval201605820
  • MFDS drugTelmistan Tablet 40/10mgRevoked2016-09-30
    Drug · Prescription · Approval201605821
  • MFDS drugSynthyroid Tablet 0.075mg2016-08-31
    Drug · Prescription · Approval201605340
  • MFDS drugLiptoc Care Sol.2016-08-26
    Drug · OTC · Notification201605110
  • MFDS drugCleatoc Topical Solution 2%2016-07-14
    Drug · OTC · Notification201604351
  • MFDS drugPregastar Capsule 75mg2016-06-21
    Drug · Prescription · Approval201603681
  • MFDS drugPregastar Capsule 150mg2016-06-21
    Drug · Prescription · Approval201603682
  • MFDS drugPregastar Capsule 300mg2016-06-21
    Drug · Prescription · Approval201603683
  • MFDS drugFBex Cataplasma2016-04-26
    Drug · OTC · Notification201602322
  • MFDS drugFBex Hanbang Cataplasma2016-04-26
    Drug · OTC · Notification201602323
  • MFDS drugCleamild Oinment2016-04-22
    Drug · OTC · Notification201602246
  • MFDS drugPhazyme-air free Chewable Tab.2016-01-08
    Drug · OTC · Approval201600173
  • MFDS drugBusomezole Tablet 40mg2015-09-30
    Drug · Prescription · Approval201506832
  • MFDS drugBusomezole Tablet 20mg2015-09-30
    Drug · Prescription · Approval201506833
  • MFDS drugNailstar Nail Lacquer2015-08-24
    Drug · OTC · Notification201505910
  • MFDS drugKids Add Chewable Tab.2015-07-23
    Drug · OTC · Notification201505023
  • MFDS drugExphen Cap.Revoked2015-07-17
    Drug · OTC · Notification201504904
  • MFDS drugTacenol Tab. 500mg2015-07-16
    Drug · OTC · Notification201504877
  • MFDS drugLonasen Tablet 8mg2015-06-29
    Drug · Prescription · Approval201504175

Showing the 80 most recent of 226 records.

Clinical trials

data.go.kr

16 MFDS clinical trial authorisations · 2012–2026 (Bioequivalence 7 · Phase 2 4 · Phase 3 2 · Phase 1 2 · Phase 2a 1)

  • Phase 3라투다정2026-06-02

    19 trial sites

  • Bioequivalence부광사피나미드정50밀리그램(가칭)(사피나미드메실산염)2025-09-10

    2 trial sites

  • Bioequivalence소마지나정500밀리그램(시티콜린나트륨)2024-09-02

    2 trial sites

  • Phase 2JM-0102022-11-07

    10 trial sites

  • Phase 2레보비르캡슐30mg(클레부딘)2021-01-07

    11 trial sites

  • Phase 2레보비르캡슐30mg(클레부딘)2020-04-14

    10 trial sites

  • Bioequivalence씬지로이드정0.2밀리그램(레보티록신나트륨수화물)2017-11-07

    2 trial sites

  • Phase 3Lurasidone HCl(SM-13496)2017-08-01

    35 trial sites

  • Phase 2MLR-1023필름코팅정2017-02-10

    21 trial sites

  • Bioequivalence리단정(탄산리튬)2017-01-12

    2 trial sites

  • Bioequivalence부광이소맥지속성캡슐(이소소르비드이질산염지속과립)2016-10-11

    2 trial sites

  • Phase 1BKP-15022016-05-02

    1 trial site

Show 4 more
  • Phase 2aMLR-1023필름코팅정2014-09-16

    10 trial sites

  • Bioequivalence크레틴정 20밀리그램2013-04-16

    2 trial sites

  • Bioequivalence부광이소맥지속성캅셀(지속성질산이소소르비드펠렛)2012-07-16
  • Phase 1BKP-10032012-02-22

    1 trial site

Global clinical trials

ClinicalTrials.gov · sponsor-matched
Show 24 more trials

R&D and key agreements

Source: DART corporate disclosure

MLR-1023 · 대사장애 및 관련 질환(당뇨병) · 제2형 당뇨병 Phase 2a·2b 완료(미국, 한국); 제1형 당뇨병 Phase 2a 진행 중(캐나다) · Bukwang returned its Asia (ex-Japan) in-licensed rights from Melior and out-licensed one of its own patents worldwide; Melior subsequently sub-licensed to Biodexa

CP-012 · Listed as a key product of the pharmaceutical R&D business segment

Key disclosures

KRX KIND via OpenDART
Show 3 more events

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 33 more patents

AI reads

MAA server logs · IP-verified
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BIO-FD&C CO.,LTD.85

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HANDOK Inc.85

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Sources and updates

Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
Approvals & clinical trials
Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
Key disclosures
KRX KIND via OpenDART exchange filings — updated daily
Global clinical trials
ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
Financials
DART corporate disclosure filings — annual
Publications
PubMed (US National Library of Medicine) — affiliation-matched, updated daily
Patents
KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
AI reads
Our server logs, IP-verified every 6 hours
AI visibility
Measured 2026-10-01

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