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Pharma & CDMOKOSDAQ 014950191 approvals33 trials

SAMIK PHARM. CO.,LTD.

Official website

Founded in 1980 and KOSDAQ-listed in 2025, Samik Pharm manufactures synthetic-drug prescription medicines for cardiovascular and diabetes treatment and operates a CMO business.

As of 2026-10-11, SAMIK PHARM. CO.,LTD. has 191 Korean MFDS drug approvals 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

Samik Pharm was founded in July 1980 and listed on KOSDAQ in October 2025 as a prescription drug manufacturer. It produces synthetic-drug based prescription medicines such as the cardiovascular agents Sezar Tab, Cadenza Tab, S-ol Tab, and Cregi Tab, and the diabetes agents Pioseeta, Januxmax, and Diaglu, alongside OTC products like motion-sickness remedies and cold medicine, while also operating a CMO business. As of end-2025 it handled 117 products, with cardiovascular agents accounting for 46.8% of sales, diabetes agents 10.7%, and CMO 11.4%, trading 32 items with 44 clients in the CMO segment.

Products & technology

  • Sezar TabCardiovascular agent (hypertension/hyperlipidemia treatment)
  • Cadenza TabCardiovascular agent (hypertension/hyperlipidemia treatment)
  • S-ol TabCardiovascular agent (hypertension/hyperlipidemia treatment)
  • Cregi TabCardiovascular agent (hypertension/hyperlipidemia treatment)
  • PioseetaDiabetes agent (blood glucose control)
  • JanuxmaxDiabetes agent (blood glucose control)
  • DiagluDiabetes agent (blood glucose control)
  • Metformin HClOral hypoglycemic agent for type 2 diabetes (CMO large-scale production)

Regulatory approvals

data.go.kr

191 Korean MFDS drug approvals · 1977–2026

  • MFDS drugCrezi Tab. 2.5mg2026-06-26
    Drug · Prescription · Approval202601815
  • MFDS drugV-CAB Tab. 20mg2026-01-27
    Drug · Prescription · Approval202600222
  • MFDS drugV-CAB Tab. 10mg2026-01-27
    Drug · Prescription · Approval202600223
  • MFDS drugGinkgostar Tab. 240mg2024-11-08
    Drug · OTC · Notification202402643
  • MFDS drugJanumaxM Tab. 50/850mg2024-02-14
    Drug · Prescription · Approval202400317
  • MFDS drugJanumaxM Tab. 50/500mg2024-02-14
    Drug · Prescription · Approval202400318
  • MFDS drugMaparam Cool Gra.2024-02-08
    Drug · OTC · Notification202400305
  • MFDS drugJanumax Tab. 50mg2024-01-15
    Drug · Prescription · Approval202400102
  • MFDS drugJanumax Tab. 25mg2024-01-15
    Drug · Prescription · Approval202400103
  • MFDS drugPiosita Tab. 100/15mg2023-08-08
    Drug · Prescription · Approval202302358
  • MFDS drugPiosita Tab. 100/30mg2023-08-07
    Drug · Prescription · Approval202302344
  • MFDS drugForxaduo Tab. 10/100mg2023-06-27
    Drug · Prescription · Approval202301959
Show 68 more
  • MFDS drugDipaglu-M XR Tab. 10/1000mg2023-01-17
    Drug · Prescription · Approval202300275
  • MFDS drugDipaglu Tab. 5mg2022-12-16
    Drug · Prescription · Approval202204518
  • MFDS drugDipaglu Tab. 10mg2022-10-31
    Drug · Prescription · Approval202203948
  • MFDS drugJanumaxM XR Tab. 100/1000mg2022-05-17
    Drug · Prescription · Approval202202077
  • MFDS drugJanumaxM XR Tab. 50/1000mg2022-05-17
    Drug · Prescription · Approval202202078
  • MFDS drugJanumaxM XR Tab. 50/500mg2022-05-17
    Drug · Prescription · Approval202202079
  • MFDS drugJanumaxM Tab. 50/1000mg2022-03-02
    Drug · Prescription · Approval202200899
  • MFDS drugOmes Duo Tab. 20/800mg2021-11-04
    Drug · Prescription · Approval202107332
  • MFDS drugRainbow CR Tab.(Levodroporpizine)Revoked2021-06-30
    Drug · Prescription · Approval202104976
  • MFDS drugEmpory Tab. 25mg(Empagliflozin)Revoked2021-03-05
    Drug · Prescription · Approval202102082
  • MFDS drugEmpory Tab. 10mg(Empagliflozin)Revoked2021-03-05
    Drug · Prescription · Approval202102083
  • MFDS drugBARODOWN TAB, 10mg/20mg2021-02-18
    Drug · Prescription · Approval202101502
  • MFDS drugBARODOWN TAB, 10mg/10mg2021-02-18
    Drug · Prescription · Approval202101503
  • MFDS drugBARODOWN TAB, 10mg/40mgRevoked2021-02-18
    Drug · Prescription · Approval202101501
  • MFDS drugZelpanic Tab. 5mgRevoked2020-09-07
    Drug · Prescription · Approval202006207
  • MFDS drugJanumax Tab. 100mg2020-07-15
    Drug · Prescription · Approval202005113
  • MFDS drugDipaclo Tab. 10mgRevoked2020-06-17
    Drug · Prescription · Approval202004454
  • MFDS drugWimoticon Tab.Revoked2020-03-30
    Drug · OTC · Notification202002183
  • MFDS drugHyden Plus Tab. 160/12.5mg2020-02-18
    Drug · Prescription · Approval202001108
  • MFDS drugHyden Tab. 160mgRevoked2020-02-10
    Drug · Prescription · Approval202000761
  • MFDS drugBiphendyl Tab. 25mgRevoked2019-12-24
    Drug · Prescription · Approval201908601
  • MFDS drugGlitina Tab. 5mgRevoked2019-10-15
    Drug · Prescription · Approval201907236
  • MFDS drugSirica Cap. 300mgRevoked2019-09-26
    Drug · Prescription · Approval201906840
  • MFDS drugBertel Plus Tab. 80/12.5mg2019-09-24
    Drug · Prescription · Approval201906696
  • MFDS drugBertel Plus Tab. 40/12.5mg2019-09-24
    Drug · Prescription · Approval201906697
  • MFDS drugGlitina Duo Tab. 2.5/850mgRevoked2019-09-16
    Drug · Prescription · Approval201906452
  • MFDS drugGlitina Duo Tab. 2.5/500mgRevoked2019-09-16
    Drug · Prescription · Approval201906453
  • MFDS drugGlitina Duo Tab. 2.5/1000mgRevoked2019-09-16
    Drug · Prescription · Approval201906454
  • MFDS drugEscar Tab. 10/40mg2019-09-11
    Drug · Prescription · Approval201906433
  • MFDS drugDirosta Tab. 5/20mgRevoked2019-09-10
    Drug · Prescription · Approval201906401
  • MFDS drugDirosta Tab. 5/10mgRevoked2019-09-10
    Drug · Prescription · Approval201906402
  • MFDS drugVarostatin Tab. 40mg2019-09-05
    Drug · Prescription · Approval201906327
  • MFDS drugMaparam Gra.2019-08-28
    Drug · OTC · Notification201906113
  • MFDS drugElbos Cap.2019-07-29
    Drug · OTC · Notification201905366
  • MFDS drugElixaban Tab. 5mg2019-07-29
    Drug · Prescription · Approval201905370
  • MFDS drugElixaban Tab. 2.5mg2019-07-29
    Drug · Prescription · Approval201905371
  • MFDS drugCavilol Tab. 12.5mg2019-07-25
    Drug · Prescription · Approval201905306
  • MFDS drugGripin Tab.30mg2019-07-22
    Drug · Prescription · Approval201905085
  • MFDS drugSBR Tab.Revoked2019-07-02
    Drug · Prescription · Approval201904509
  • MFDS drugDecartan Tab. 8mg2019-06-18
    Drug · Prescription · Approval201904229
  • MFDS drugDecartan Tab. 16mg2019-06-18
    Drug · Prescription · Approval201904230
  • MFDS drugCetroc Tab. 250mgRevoked2019-05-20
    Drug · Prescription · Approval201903235
  • MFDS drugDurchid HR Tab. 600mg2019-04-29
    Drug · Prescription · Approval201902754
  • MFDS drugEsca Tab. 5/20mg2019-04-11
    Drug · Prescription · Approval201902221
  • MFDS drugEsca Tab. 5/40mg2019-04-11
    Drug · Prescription · Approval201902222
  • MFDS drugNewtod Tab. 50mgRevoked2019-03-29
    Drug · Prescription · Approval201901932
  • MFDS drugEsca HCT Tab. 5/40/12.5mg2019-03-19
    Drug · Prescription · Approval201901667
  • MFDS drugDrabe Tab. 20mg2019-01-31
    Drug · Prescription · Approval201900772
  • MFDS drugDrabe Tab. 10mg2019-01-31
    Drug · Prescription · Approval201900778
  • MFDS drugGichikol Tab.Revoked2019-01-31
    Drug · Prescription · Notification201900758
  • MFDS drugEsca HCT Tab. 10/40/12.5mg2019-01-18
    Drug · Prescription · Approval201900269
  • MFDS drugEsca HCT Tab. 5/20/12.5mg2019-01-18
    Drug · Prescription · Approval201900270
  • MFDS drugDoperin Tab. 10mg2018-12-18
    Drug · Prescription · Approval201805143
  • MFDS drugSovomin Syr.2018-02-28
    Drug · OTC · Notification201801011
  • MFDS drugThe Thid Tab.2018-02-26
    Drug · Prescription · Approval201800947
  • MFDS drugFluvir Cap. 75mg2017-10-18
    Drug · Prescription · Approval201707506
  • MFDS drugAlenas Tab.2017-09-12
    Drug · Prescription · Approval201707062
  • MFDS drugMediroll Tab. 4mg2017-04-28
    Drug · Prescription · Approval201702259
  • MFDS drugEravix Plus Cap.2017-03-30
    Drug · Prescription · Approval201701528
  • MFDS drugGaneu Tab. 300mg2017-02-08
    Drug · Prescription · Notification201700691
  • MFDS drugVersace Tab. 40/5mg2016-11-25
    Drug · Prescription · Approval201606770
  • MFDS drugVersace Tab. 40/10mg2016-11-25
    Drug · Prescription · Approval201606771
  • MFDS drugVersace Tab. 80/5mg2016-11-25
    Drug · Prescription · Approval201606772
  • MFDS drugSolitear Tab. 5mg2016-07-04
    Drug · Prescription · Approval201604147
  • MFDS drugSolitear Tab. 10mgRevoked2016-07-04
    Drug · Prescription · Approval201604148
  • MFDS drugShapran Tab. 100mg2016-05-30
    Drug · Prescription · Approval201603033
  • MFDS drugOmes Tab. 20mg2016-02-16
    Drug · Prescription · Approval201600875
  • MFDS drugOmes Tab. 40mg2015-11-17
    Drug · Prescription · Approval201507736

Showing the 80 most recent of 191 records.

Clinical trials

data.go.kr

33 MFDS clinical trial authorisations · 2012–2026 (Bioequivalence 28 · Phase 1 4 · Phase 2 1)

  • Phase 1SICH-2601-12026-07-14

    2 trial sites

  • Phase 1SICL-2601-12026-07-14

    2 trial sites

  • BioequivalenceSIED-2501-12025-02-17

    1 trial site

  • BioequivalenceSIVC-2401-12024-04-18

    1 trial site

  • BioequivalenceSICT-2211-12023-01-06

    2 trial sites

  • Bioequivalence레인보우정(레보드로프로피진)2022-09-29

    2 trial sites

  • Phase 1SIPS-2209-12022-07-25

    2 trial sites

  • Phase 2SIKD19772022-05-19

    3 trial sites

  • Bioequivalence후루칸정150밀리그램(플루코나졸)2022-03-02

    2 trial sites

  • Bioequivalence바로스타틴정40밀리그램(아토르바스타틴칼슘삼수화물)2022-02-14

    2 trial sites

  • Bioequivalence그리핀정30밀리그램(피오글리타존염산염)2021-10-27

    2 trial sites

  • Phase 1SIFZ-2110-12021-09-02

    2 trial sites

Show 21 more
  • Bioequivalence다파글루정10밀리그램(다파글리플로진프로판디올수화물)2021-05-25

    2 trial sites

  • Bioequivalence다파글루엠서방정10/1000밀리그램2021-04-29

    2 trial sites

  • Bioequivalence다파글루엠서방정10/1000밀리그램2021-04-29

    2 trial sites

  • Bioequivalence그리핀정30밀리그램(피오글리타존염산염)2021-01-14

    2 trial sites

  • Bioequivalence에스카정10/40밀리그램2020-09-04

    2 trial sites

  • Bioequivalence세클펜정(아세클로페낙)(수출명:CECLOFEN Tab.)2020-08-06

    2 trial sites

  • Bioequivalence바로스타틴정40밀리그램(아토르바스타틴칼슘삼수화물)2020-07-02

    2 trial sites

  • Bioequivalence디로바정10mg(암로디핀베실산염)2020-06-24

    2 trial sites

  • Bioequivalence카덴자정10/160mg2020-06-05

    2 trial sites

  • Bioequivalence자누맥스엠정50/1000밀리그램2019-11-27

    1 trial site

  • Bioequivalence자누맥스정(시타글립틴인산염수화물)2019-04-01

    1 trial site

  • Bioequivalence카덴자정10/160mg2018-04-10

    2 trial sites

  • Bioequivalence에라빅스정(클로피도그렐황산수소염)2017-05-15

    2 trial sites

  • Bioequivalence메디롤정4mg(글리메피리드)2016-03-07

    2 trial sites

  • Bioequivalence이타나졸정(이트라코나졸)2015-11-19
  • Bioequivalence메모코드정(콜린알포세레이트)2015-07-07
  • Bioequivalence아로카정10/40mg2014-07-22
  • Bioequivalence크레지정20mg(로수바스타틴칼슘)2014-03-28
  • Bioequivalence세라비정2013-05-27
  • Bioequivalence삼익글루엠엑스알정(가칭)2013-01-15
  • Bioequivalence에스토정(라푸티딘)2012-07-17

    1 trial site

R&D and key agreements

Source: DART corporate disclosure

SIST2402 · 본태성 고혈압 · 임상1상 · First combination product of S-amlodipine besylate and losartan potassium (low/high dose) for essential hypertension, developed as a chiral drug switching the comparator amlodipine to S-amlodipine to obtain new isomer NDA status; being developed as a first generic, running 2024.03-2027.11.

SLIM2401 · 자가면역질환(류마티스관절염, 원형탈모증 등) · Applying UniSphero technology to develop an oral JAK-inhibitor autoimmune disease treatment as a biodegradable-polymer-based long-acting (1-month) injectable improved new drug, running 2024.03-2027.03.

SLIM2402 · 항암·면역보조 치료 · Project developing a cancer/immune-adjuvant therapeutic as an improved new drug in long-acting injectable form, applying UniSphero technology.

Patents

KIPRIS · applicant-matched
Show 5 more patents

AI reads

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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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