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Pharma & CDMOKOSPI 019170344 approvals76 trials

SHINPOONG PHARMACEUTICAL CO.,LTD

Official website

Founded in 1986 and listed on the KOSPI in 1990, Shinpoong Pharmaceutical manufactures antibiotics, thrombolytics, psychotropics, and anthelmintics.

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Market cap

Products & technology

  • AntibioticsAntibiotic
  • ThrombolyticsThrombolytic agent
  • Psychotropic drugsPsychotropic drug
  • AnthelminticsAnthelmintic

Regulatory approvals

data.go.kr

340 Korean MFDS drug approvals · 1982–2026 / 4 Korean MFDS device approvals · 2011–2014

  • MFDS drugShinpoong Fosfomycin Sodium 4g for Injection2026-04-06
    Drug · Prescription · Approval202600958
  • MFDS drugStafeno Capsule2025-04-30
    Drug · Prescription · Approval202501046
  • MFDS drugMyvical tab.2025-03-17
    Drug · OTC · Notification202500577
  • MFDS drugAvocial Tablet 0.5/5mg(Dutasteride,Tadalafil)2025-01-23
    Drug · Prescription · Approval202500184
  • MFDS drugHighginkgo Tab. 240mg2024-12-12
    Drug · OTC · Notification202402950
  • MFDS drugShinpoong Fosfomycin Sodium 3% for Otic2024-10-18
    Drug · Prescription · Approval202402463
  • MFDS drugShinpoong Fosfomycin Sodium 2g for Injection2024-09-09
    Drug · Prescription · Approval202402186
  • MFDS drugShinpoong Fosfomycin Sodium 1g for Injection2024-09-09
    Drug · Prescription · Approval202402187
  • MFDS drugShinpoong Fosfomycin Sodium 0.5g for Injection2024-09-09
    Drug · Prescription · Approval202402188
  • MFDS drugHyalflex Injection2024-07-12
    Drug · Prescription · Approval202401722
  • MFDS drugShinpoong azithromycin tablet 500mg2024-06-28
    Drug · Prescription · Approval202401582
  • MFDS drugCeracin Capsule 400mg2024-05-31
    Drug · Prescription · Approval202401355
Show 68 more
  • MFDS drugLinaroutine Duo Tablet 2.5/850mg2024-04-30
    Drug · Prescription · Approval202401058
  • MFDS drugLinaroutine Duo Tablet 2.5/500mg2024-04-30
    Drug · Prescription · Approval202401059
  • MFDS drugLinaroutine Duo Tablet 2.5/1000mg2024-04-30
    Drug · Prescription · Approval202401060
  • MFDS drugLinaroutine Tablet 5mg2024-03-29
    Drug · Prescription · Approval202400697
  • MFDS drugLINARUTIN XR TABLET 5/1000MG2024-03-22
    Drug · Prescription · Approval202400628
  • MFDS drugLINARUTIN XR TABLET 2.5/1000MG2024-03-22
    Drug · Prescription · Approval202400629
  • MFDS drugShinpoong Acetaminophen Injection2024-02-22
    Drug · Prescription · Approval202400384
  • MFDS drugEmparoutine duo tablet 12.5/500mg2023-08-30
    Drug · Prescription · Approval202302563
  • MFDS drugEmparoutine duo tablet 12.5/850mg2023-08-30
    Drug · Prescription · Approval202302564
  • MFDS drugEmparoutine duo tablet 12.5/1000mg2023-08-30
    Drug · Prescription · Approval202302565
  • MFDS drugRoxagen XR Tab.2023-08-28
    Drug · Prescription · Approval202302536
  • MFDS drugShinpoong Edoxaban Tab. 60mg2023-04-25
    Drug · Prescription · Approval202301340
  • MFDS drugShinpoong Edoxaban Tab. 30mg2023-04-25
    Drug · Prescription · Approval202301341
  • MFDS drugCHOLOSTAR Tab. 2.5mg2023-03-31
    Drug · Prescription · Approval202301094
  • MFDS drugShinpoong sitaplus tab. 50/850mg2023-03-13
    Drug · Prescription · Approval202300857
  • MFDS drugShinpoong sitaplus tab. 50/500mg2023-03-13
    Drug · Prescription · Approval202300858
  • MFDS drugShinpoong sitaplus tab. 50/1000mg2023-03-13
    Drug · Prescription · Approval202300859
  • MFDS drugEzerosu Tab. 10/2.5mg2023-03-10
    Drug · Prescription · Approval202300829
  • MFDS drugSitaroutine Duo XR tab. 50/500mg2023-02-17
    Drug · Prescription · Approval202300590
  • MFDS drugSitaroutine Duo XR tab. 50/1000mg2023-02-17
    Drug · Prescription · Approval202300591
  • MFDS drugSitaroutine Duo XR tab. 50/1000mg2023-02-17
    Drug · Prescription · Approval202300592
  • MFDS drugDaparoutine Duo XR Tablet 10/1000mg2023-01-27
    Drug · Prescription · Approval202300355
  • MFDS drugFimadipine Tab. 30/2.5mg2022-12-27
    Drug · Prescription · Approval202204661
  • MFDS drugFimadipine Tab. 60/2.5mg2022-12-27
    Drug · Prescription · Approval202204662
  • MFDS drugBef XR tablet2022-12-21
    Drug · Prescription · Approval202204553
  • MFDS drugBaropera injection2022-08-04
    Drug · Prescription · Approval202203227
  • MFDS drugTerigglemet XR Tab. 20/1000mg2022-07-01
    Drug · Prescription · Approval202202740
  • MFDS drugTerigglemet XR Tab. 10/750mg2022-07-01
    Drug · Prescription · Approval202202741
  • MFDS drugTerigglemet XR Tab. 10/500mg2022-06-28
    Drug · Prescription · Approval202202675
  • MFDS drugTeriggle Tab. 20mg2022-04-27
    Drug · Prescription · Approval202201759
  • MFDS drugEmparoutine duo tablet 5/500mg2022-04-04
    Drug · Prescription · Approval202201360
  • MFDS drugEmparoutine duo tablet 5/1000mg2022-04-04
    Drug · Prescription · Approval202201361
  • MFDS drugEmparoutine duo tablet 5/850mg2022-04-04
    Drug · Prescription · Approval202201362
  • MFDS drugLovedion Injection2022-03-11
    Drug · Prescription · Approval202201006
  • MFDS drugDaparoutine 10mg Tablet2022-03-11
    Drug · Prescription · Approval202201016
  • MFDS drugDaparoutine 5mg TabletRevoked2022-03-08
    Drug · Prescription · Approval202200980
  • MFDS drugShinpoong Linagliptin Tab. 5mgRevoked2022-02-07
    Drug · Prescription · Approval202200559
  • MFDS drugGavely tablet2022-01-19
    Drug · Prescription · Approval202200347
  • MFDS drugDaparoutine Star Tablet 10/100mg2022-01-04
    Drug · Prescription · Approval202200044
  • MFDS drugGavelimet Tablet2021-10-25
    Drug · Prescription · Approval202107111
  • MFDS drugSitaroutine Tab. 50mg2021-03-22
    Drug · Prescription · Approval202102483
  • MFDS drugSitaroutine Tab. 25mg2021-03-22
    Drug · Prescription · Approval202102484
  • MFDS drugSitaroutine Tab. 100mg2021-03-22
    Drug · Prescription · Approval202102485
  • MFDS drugEmparoutine tablet 25mgRevoked2021-03-05
    Drug · Prescription · Approval202102111
  • MFDS drugEmparoutine tablet 10mgRevoked2021-03-05
    Drug · Prescription · Approval202102112
  • MFDS drugGastak SR Tab. 15mg2020-04-28
    Drug · Prescription · Approval202003104
  • MFDS drugDenausea EC tablet2020-04-03
    Drug · Prescription · Notification202002354
  • MFDS drugDybis Tab.2020-03-27
    Drug · Prescription · Approval202002163
  • MFDS drugRobavin Cap. (for export)2020-03-11
    Drug · Prescription · Approval202001691
  • MFDS drugDaibis XR Tab. 500mg2020-01-06
    Drug · Prescription · Approval202000084
  • MFDS drugPonstel Cap.2019-12-02
    Drug · Prescription · Notification201908188
  • MFDS drugFamcrin Tab. 250mg2019-10-28
    Drug · Prescription · Approval201907499
  • MFDS drugSseuk Join Tab.2019-08-07
    Drug · Prescription · Notification201905574
  • MFDS drugLostal XR Cap. 200mg2019-05-31
    Drug · Prescription · Approval201903645
  • MFDS drugLostal XR Cap. 100mg2019-05-31
    Drug · Prescription · Approval201903646
  • MFDS drugShinpoong Flu Suspension Powder 6mg/mL(50mL)Revoked2019-05-22
    Drug · Prescription · Approval201903330
  • MFDS drugAlz-Choline Syrup2019-03-29
    Drug · Prescription · Approval201901947
  • MFDS drugHyal Oneshot Inj.2019-03-08
    Drug · Prescription · Approval201901450
  • MFDS drugUtaren 2X Tab.2019-01-22
    Drug · Prescription · Approval201900320
  • MFDS drugTicarinta Tab. 90mgRevoked2018-11-27
    Drug · Prescription · Approval201804674
  • MFDS drugLosanne Tab.2018-10-31
    Drug · Prescription · Approval201804326
  • MFDS drugTostapin Tab. 5/10mgRevoked2018-10-30
    Drug · Prescription · Approval201804289
  • MFDS drugBAZECALD Tab.2018-10-10
    Drug · Prescription · Approval201803969
  • MFDS drugBef Tab.2018-03-28
    Drug · Prescription · Approval201801369
  • MFDS drugAlz-Choline Tab.2018-03-27
    Drug · Prescription · Approval201801335
  • MFDS drugCompacteno Tab.2017-11-29
    Drug · Prescription · Approval201708125
  • MFDS drugHayaron Inj. 1200mg2017-11-01
    Drug · Prescription · Notification201707678
  • MFDS drugHayaron Inj.2017-11-01
    Drug · Prescription · Notification201707679

Showing the 80 most recent of 344 records.

Clinical trials

data.go.kr

76 MFDS clinical trial authorisations · 2012–2026 (Bioequivalence 49 · Phase 1 11 · Phase 3 6 · Phase 2 6 · Phase 2a 2)

  • Bioequivalence아보탐스캡슐2026-04-08

    2 trial sites

  • Bioequivalence아보탐스캡슐2026-04-08

    2 trial sites

  • Bioequivalence보노판정20밀리그램2026-03-06

    2 trial sites

  • Bioequivalence로베타존정0.5밀리그램(로베글리타존황산염)2025-08-04

    2 trial sites

  • Bioequivalence브레트라정(레트로졸)2025-06-30

    2 trial sites

  • Phase 3SP-8203 주2024-10-14

    32 trial sites

  • Phase 2SPC10012024-08-01

    18 trial sites

  • Bioequivalence크라목신네오건조시럽2024-06-04

    2 trial sites

  • Bioequivalence크라목신듀오건조시럽2024-06-04

    2 trial sites

  • Bioequivalence스타페노캡슐2023-11-01

    2 trial sites

  • Bioequivalence브레트라정(레트로졸)2023-05-03

    2 trial sites

  • Phase 3SP5M002주2023-04-06

    32 trial sites

Show 64 more
  • Bioequivalence록스펜씨알정(록소프로펜나트륨)2022-12-08

    2 trial sites

  • Bioequivalence록스펜씨알정(록소프로펜나트륨)2022-12-06

    2 trial sites

  • Bioequivalence록스펜씨알정(록소프로펜나트륨)2022-09-20

    2 trial sites

  • Phase 2SPC10012022-07-18

    18 trial sites

  • Phase 2피라맥스정2022-06-13

    1 trial site

  • Bioequivalence뉴페리손정(에페리손염산염)2022-02-25

    2 trial sites

  • Bioequivalence몬테나정10밀리그램(몬테루카스트나트륨)2022-02-21

    2 trial sites

  • Bioequivalence에제로수정10/20밀리그램2021-11-24

    1 trial site

  • Phase 2SPC10012021-10-13

    19 trial sites

  • Phase 3피라맥스정2021-08-27

    33 trial sites

  • Phase 1/2SP5M002주2021-06-09

    2 trial sites

  • Phase 3SP5M001주2021-03-16

    14 trial sites

  • Bioequivalence알츠코린정2020-06-08

    2 trial sites

  • Phase 2피라맥스정2020-05-13

    13 trial sites

  • Phase 1SPC2001, SPC50012019-12-30

    2 trial sites

  • Bioequivalence베타미론서방정50밀리그램(미라베그론)2019-07-11

    2 trial sites

  • Bioequivalence베타미론서방정50밀리그램(미라베그론)2019-07-11

    2 trial sites

  • Phase 2bSP-8203 주2018-12-05

    14 trial sites

  • Bioequivalence베타미론서방정50밀리그램(미라베그론)2018-07-10

    2 trial sites

  • Bioequivalencedienogest2016-09-12

    2 trial sites

  • Bioequivalence비리테노정2016-09-09

    2 trial sites

  • Bioequivalence티카린타정90밀리그램2016-08-02

    2 trial sites

  • Bioequivalence알츠코린정(콜린알포세레이트)2016-06-30

    2 trial sites

  • Phase 2aSP-8203 주2015-09-22

    8 trial sites

  • Phase 1SP5M001주2015-05-14

    2 trial sites

  • Bioequivalence칸세틸플러스정2015-04-15

    2 trial sites

  • Bioequivalence칸세틸정16밀리그램(칸데사르탄실렉세틸)2015-03-18

    2 trial sites

  • Phase 3(가칭) 칸데암로정2015-02-13

    11 trial sites

  • Phase 1(가칭)에제로수정2015-01-09

    1 trial site

  • Phase 1(가칭) 칸데암로정2014-12-31

    1 trial site

  • Bioequivalence실로패스캡슐 4밀리그램(실로도신)2014-12-24

    2 trial sites

  • Phase 1SP3R0012014-12-12

    1 trial site

  • Bioequivalence프레야지정60밀리그램(다폭세틴염산염)2014-11-26

    2 trial sites

  • Phase 2aSPP-501정2014-11-25

    1 trial site

  • Bioequivalence페노렌캡슐(미세화페노피브레이트구형과립)2014-11-21

    2 trial sites

  • Bioequivalence페트리센정80밀리그램(페북소스타트)2014-11-20

    2 trial sites

  • Bioequivalence베라졸정 20mg2014-10-02

    2 trial sites

  • Bioequivalence텔미디탄정80/5밀리그램2014-10-02

    2 trial sites

  • Bioequivalence이레피논정(게피티니브)2014-09-19

    2 trial sites

  • Phase 3(가칭)에제로수정2014-08-06

    20 trial sites

  • Bioequivalence잘프로정(잘토프로펜)2014-07-25

    2 trial sites

  • Phase 2(가칭) 칸데암로정2014-05-07

    22 trial sites

  • Bioequivalence바로타다정20밀리그램(타다라필)2014-03-25

    2 trial sites

  • Bioequivalence아모디탄정 5/40밀리그램2013-11-08

    1 trial site

  • Bioequivalence듈로타캡슐60밀리그램(둘록세틴염산염)2013-10-10

    2 trial sites

  • Bioequivalence바로페질정10밀리그램(도네페질염산염일수화물)2013-09-30

    2 trial sites

  • Phase 1SP-8203 주2013-09-25

    1 trial site

  • Bioequivalence바로콕스캡슐200밀리그램(세레콕시브)2013-06-13

    2 trial sites

  • Bioequivalence시타글루정100mg(시타글립틴인산염수화물)2013-06-05

    1 trial site

  • Phase 1(가칭) 칸데암로정2013-05-24

    1 trial site

  • Bioequivalence신풍비페닐디메틸디카르복실산염/우르소데옥시콜산캡슐(가칭)2013-05-15

    2 trial sites

  • Bioequivalence잘프로정(잘토프로펜)2013-04-15

    2 trial sites

  • Phase 1피라맥스과립2013-03-15

    1 trial site

  • Bioequivalence투스타핀정5/20밀리그램2013-02-22

    2 trial sites

  • Bioequivalence아덱셀런스패취10(리바스티그민)2013-02-01

    2 trial sites

  • Bioequivalence하이듀오정2013-01-29

    1 trial site

  • Bioequivalence암로발탄정10/160밀리그램2012-10-10

    1 trial site

  • Bioequivalence바로필정100밀리그램(실데나필시트르산염)2012-08-28

    1 trial site

  • Bioequivalence브레트라정(레트로졸)2012-08-01
  • Bioequivalence솔페나신정10밀리그램(숙신산솔리페나신)2012-07-19

    1 trial site

  • Phase 1블루벡필름코팅정400밀리그램(이매티닙메실산염)2012-07-13

    1 trial site

  • Bioequivalence큐프론정(염산시프로플록사신)(수출명 : SP Ciprofloxacin Tablets, SHINPOONG QUPRON Tablets, SHINPOONG QUPRON Film coated tablet)2012-06-22

    2 trial sites

  • Phase 1멧퓨어엑스엘정(에스메토프로롤숙시네이트)2012-01-18

    1 trial site

  • Phase 1멧퓨어엑스엘정(에스메토프로롤숙시네이트)2012-01-13

    1 trial site

Not yet compiled: business overview · R&D. Send us materials and we will add them

Companies approved for the same productsPharma & CDMO

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

BASKHANBIOPharma Inc.1 shared

Founded 1986, KONEX-listed since 2022, BASKHANBIOPharma makes drugs and medical devices for use before and after surgery.

BioPlus Co., Ltd1 shared

Founded in 2003 and KOSDAQ-listed in 2021, BioPlus develops HA-based bio medical devices and biopharmaceuticals using its proprietary MDM Technology platform.

Boditech Med Inc.1 shared

KOSDAQ-listed point-of-care immunodiagnostics company supplying diagnostic cartridges and the ichroma/AFIAS instrument series.

GC Medical Science Corporation1 shared

GC Medical Science Corporation, KOSDAQ-listed since 2014, operates diagnostic reagent, blood glucose, and hemodialysis solution businesses.

i-SENS, Inc.1 shared

Founded in 2000 and KOSDAQ-listed in 2013, i-SENS makes blood glucose monitors and point-of-care testing devices.

L&C BIO Co., Ltd1 shared

L&C BIO manufactures human tissue grafts across 11 tissue types, including the acellular dermal matrix MegaDerm, plus tissue-based medical devices.

OSANG HEALTHCARE CO.,LTD.1 shared

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

PharmaResearch Co., Ltd.1 shared

KOSDAQ-listed medical device company producing PDRN pharmaceuticals, HA fillers, and Rejuran-branded cosmetics.

SD BIOSENSOR INC.1 shared

KOSPI-listed in-vitro diagnostics company known for the STANDARD Q antigen/antibody test kits.

SHINHUNG CO.,LTD1 shared

Founded in 1964 and KOSPI-listed in 1991, Shinhung manufactures and distributes dental equipment and materials.

TASCOM Co.,Ltd.1 shared

Develops SimplexTAS, a point-of-care clinical chemistry and immunoassay analyzer for IVD testing.

WSI Co., Ltd.1 shared

Founded and KOSDAQ-listed in 2018, WSI distributes spine/joint devices and has expanded into medical robots and pharma via subsidiaries.

Sources and updates

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Compiled from disclosure filings
AI visibility
Measured 2026-08-13

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