Medical AI Alliance
← Company Index
Pharma & CDMOKOSPI 001360238 approvals3 trials

SAMSUNG PHARMACEUTICAL.CO.,Ltd.

Official website

Samsung Pharmaceutical (est. 1929, KOSPI 1975) is a Gemvax & Kael affiliate selling Kasmyungsu and developing GV1001 biotech pipelines.

Price

Change

Market cap

Business overview

Source: DART corporate disclosure

Founded in 1929 and KOSPI-listed in 1975, Samsung Pharmaceutical is an affiliate of controlling shareholder Gemvax & Kael, engaged in pharmaceutical manufacturing and sales, biotech, and health food manufacturing and sales. Prescription drugs span about 80 lines including antibiotics and prostate treatments sold via CSOs; OTC products like Kasmyungsu and Pantoae are supplied to pharmacies and convenience stores under an exclusive deal with Jeil Health Science; and 18 ETC items including injections go exclusively to Ilhwa Co., Ltd. In biotech, the company ran a Phase 3 trial of GV1001 for pancreatic cancer licensed from Gemvax & Kael, gained an exclusive Alzheimer's license in 2023, and in December 2025 licensed GV1001 for progressive supranuclear palsy in 3 countries outside Korea, posting sales of 44,678,747 (pharma) and 1,395,633 (health food), totaling 46,074,380.

Products & technology

  • KasmyungsuOTC drug supplied to pharmacies and convenience stores under an exclusive agreement with Jeil Health Science Co., Ltd.
  • PantoaeOTC drug supplied to pharmacies and convenience stores under an exclusive agreement with Jeil Health Science Co., Ltd.
  • 리아백스주Pancreatic cancer treatment (GV1001-based)

Regulatory approvals

data.go.kr

237 Korean MFDS drug approvals · 1987–2026 / 1 Korean MFDS device approvals · 2017

  • MFDS drugSamsung tegoprazan Tab.50mg2026-04-30
    Drug · Prescription · Approval202601297
  • MFDS drugSamsung tegoprazan Tab.25mg2026-04-30
    Drug · Prescription · Approval202601298
  • MFDS drugSamsung tofacitinib tab. 10mg2025-08-22
    Drug · Prescription · Approval202502183
  • MFDS drugSamsung Citrulline Tab.2025-07-28
    Drug · OTC · Approval202501936
  • MFDS drugSamsung Tromela Tab.2025-07-22
    Drug · OTC · Notification202501843
  • MFDS drugZetrizine tab.2025-07-09
    Drug · OTC · Notification202501708
  • MFDS drugSamsung Ginkgo Q Tab. 240mg2024-11-07
    Drug · OTC · Notification202402634
  • MFDS drugCleansweat solution2023-11-27
    Drug · OTC · Notification202303225
  • MFDS drugEmpameta Tab. 12.5/500mg2023-09-12
    Drug · Prescription · Approval202302733
  • MFDS drugEmpameta Tab. 12.5/850mg2023-09-12
    Drug · Prescription · Approval202302734
  • MFDS drugEmpameta Tab. 12.5/1000mg2023-09-12
    Drug · Prescription · Approval202302735
  • MFDS drugSamsung edoxaban tab.60mg2023-05-02
    Drug · Prescription · Approval202301435
Show 68 more
  • MFDS drugSamsung edoxaban tab.30mg2023-05-02
    Drug · Prescription · Approval202301436
  • MFDS drugSamsung dapagliflozin tab.2023-01-11
    Drug · Prescription · Approval202300205
  • MFDS drugSamdapaduo tablet2023-01-03
    Drug · Prescription · Approval202300030
  • MFDS drugSamsung Ibuprofen pre-mix inj.2022-06-07
    Drug · Prescription · Approval202202348
  • MFDS drugEmpamet Tab. 5/1000mg2022-04-04
    Drug · Prescription · Approval202201366
  • MFDS drugEmpamet Tab. 5/500mg2022-04-04
    Drug · Prescription · Approval202201367
  • MFDS drugEmpamet Tab. 5/850mg2022-04-04
    Drug · Prescription · Approval202201368
  • MFDS drugsamsung sugammadex injection2022-02-08
    Drug · Prescription · Approval202200594
  • MFDS drugSamsita Plus Tab. 50/500mg2021-12-30
    Drug · Prescription · Approval202108201
  • MFDS drugSamsita Plust Tab. 50/850mg2021-12-30
    Drug · Prescription · Approval202108202
  • MFDS drugSamsita Plust Tab. 50/1000mg2021-12-30
    Drug · Prescription · Approval202108203
  • MFDS drugSamsung Donepezil Tab. 23mg(Donepezil Hydrochloride Monohydrate)Revoked2021-05-03
    Drug · Prescription · Approval202103643
  • MFDS drugXAROXABAN Tab. 20mg(Rivaroxaban)Revoked2021-04-29
    Drug · Prescription · Approval202103500
  • MFDS drugXAROXABAN Tab. 15mg(Rivaroxaban)Revoked2021-04-29
    Drug · Prescription · Approval202103501
  • MFDS drugXAROXABAN Tab. 10mg(Rivaroxaban)Revoked2021-04-29
    Drug · Prescription · Approval202103502
  • MFDS drugEmpa Tab. 10mg(empagliflozin)Revoked2021-03-05
    Drug · Prescription · Approval202102074
  • MFDS drugEmpa Tab. 25mg(empagliflozin)Revoked2021-03-05
    Drug · Prescription · Approval202102075
  • MFDS drugSamtozet Tab. 10/10mg2021-02-18
    Drug · Prescription · Approval202101550
  • MFDS drugSamtozet Tab. 10/20mg2021-02-18
    Drug · Prescription · Approval202101551
  • MFDS drugSamtozet Tab. 10/10mg2021-02-18
    Drug · Prescription · Approval202101552
  • MFDS drugSamsung tofacitinib tab. 5mgRevoked2021-01-07
    Drug · Prescription · Approval202100149
  • MFDS drugSam Sita Tab. 25mg2020-05-29
    Drug · Prescription · Approval202004039
  • MFDS drugSam Sita Tab. 50mg2020-05-29
    Drug · Prescription · Approval202004040
  • MFDS drugSam Sita Tab. 100mg2020-05-29
    Drug · Prescription · Approval202004041
  • MFDS drugSamtis Cap.2020-05-22
    Drug · OTC · Notification202003769
  • MFDS drugUparen 2X Tab.2020-05-01
    Drug · Prescription · Approval202003251
  • MFDS drugGasprin SR Tab. 15mg2020-04-24
    Drug · Prescription · Approval202003033
  • MFDS drugSamsung Tamsulosin SR Tab. 0.4mg2020-04-17
    Drug · Prescription · Approval202002729
  • MFDS drugSamsung Dobesilate Tab.2020-04-16
    Drug · Prescription · Approval202002668
  • MFDS drugSamsung Polaprezinc Tab.Revoked2020-03-31
    Drug · Prescription · Approval202002231
  • MFDS drugSamsung Buspirone Tab. 5mgRevoked2020-03-31
    Drug · Prescription · Approval202002242
  • MFDS drugSamsung Buspirone Tab. 10mgRevoked2020-03-31
    Drug · Prescription · Approval202002243
  • MFDS drugSamsung Octylonium Tab.2020-03-19
    Drug · Prescription · Approval202001922
  • MFDS drugSamsung Itopride Tab.2020-03-19
    Drug · Prescription · Approval202001924
  • MFDS drugS-fenac Beta Inj.Revoked2020-03-13
    Drug · Prescription · Notification202001746
  • MFDS drugsamsung Aspirin Enteric Coated Tab. 100mg2020-03-03
    Drug · OTC · Notification202001489
  • MFDS drugSamxetil Tab.2020-03-02
    Drug · Prescription · Approval202001476
  • MFDS drugSamsung Irsogladine Tab.Revoked2020-02-28
    Drug · Prescription · Approval202001425
  • MFDS drugSamsung Epinastine Tab. 20mgRevoked2020-02-21
    Drug · Prescription · Approval202001243
  • MFDS drugSamsung Palonosetron Inj.Revoked2020-02-18
    Drug · Prescription · Approval202001110
  • MFDS drugSamsung Rasagiline Tab. 1mgRevoked2020-02-04
    Drug · Prescription · Approval202000578
  • MFDS drugSamsung Rasagiline Tab. 0.5mgRevoked2020-02-04
    Drug · Prescription · Approval202000579
  • MFDS drugFeder-S Tab.2020-01-31
    Drug · OTC · Notification202000536
  • MFDS drugSamsung Amorolfine Nail Lacquer2020-01-22
    Drug · OTC · Notification202000375
  • MFDS drugSpeelong Solution2019-12-17
    Drug · OTC · Notification201908484
  • MFDS drugsamsung prucalopride succinate Tab. 1mgRevoked2019-12-13
    Drug · Prescription · Approval201908400
  • MFDS drugsamsung prucalopride succinate Tab. 2mgRevoked2019-12-13
    Drug · Prescription · Approval201908401
  • MFDS drugsamsung famotidine tablet 20mg2019-12-12
    Drug · Prescription · Approval201908381
  • MFDS drugsamsung dutasteride tablet 0.5mg2019-11-20
    Drug · Prescription · Approval201908004
  • MFDS drugsamsung bromelain enteric coated tablet2019-10-31
    Drug · OTC · Notification201907617
  • MFDS drugQ-sen 400 Ibuprofen Soft Cap.2019-10-28
    Drug · OTC · Notification201907485
  • MFDS drugsamsung linagliptin duo tablet 2.5/850mgRevoked2019-10-28
    Drug · Prescription · Approval201907496
  • MFDS drugsamsung linagliptin duo tablet 2.5/500mgRevoked2019-10-28
    Drug · Prescription · Approval201907497
  • MFDS drugsamsung linagliptin duo tablet 2.5/1000mgRevoked2019-10-28
    Drug · Prescription · Approval201907498
  • MFDS drugsamsung finasteride tablet2019-10-07
    Drug · Prescription · Approval201907100
  • MFDS drugItec-F Tab.Revoked2019-09-24
    Drug · OTC · Notification201906686
  • MFDS drugNewnexin Tab.Revoked2019-09-23
    Drug · Prescription · Approval201906633
  • MFDS drugsamsung gabapentin capsuleRevoked2019-09-23
    Drug · Prescription · Approval201906634
  • MFDS drugsamsung tulobuterol patch 0.5mgRevoked2019-09-18
    Drug · Prescription · Approval201906551
  • MFDS drugsamsung tulobuterol patch 2mgRevoked2019-09-18
    Drug · Prescription · Approval201906552
  • MFDS drugsamsung tulobuterol patch 1mgRevoked2019-09-18
    Drug · Prescription · Approval201906553
  • MFDS drugsamsung propiverine tablet (propiverine hydrochloride)Revoked2019-09-11
    Drug · Prescription · Approval201906425
  • MFDS drugsamsung linagliptin tablet 5mgRevoked2019-09-03
    Drug · Prescription · Approval201906266
  • MFDS drugSamsung Taurolidine InjectionRevoked2019-08-20
    Drug · Prescription · Notification201905869
  • MFDS drugSamsung Eperisone SR Tab.2019-08-12
    Drug · Prescription · Approval201905672
  • MFDS drugsamsung azelastine tabletRevoked2019-08-07
    Drug · Prescription · Approval201905584
  • MFDS drugTaperacin Inj. 2.25g2019-08-05
    Drug · Prescription · Notification201905510
  • MFDS drugsamsung ceftriaxone sodium hydrate injection 2mg2019-07-24
    Drug · Prescription · Notification201905264

Showing the 80 most recent of 238 records.

Clinical trials

data.go.kr

3 MFDS clinical trial authorisations · 2015–2022 (Phase 3 2 · Bioequivalence 1)

  • Phase 3GV10012022-01-14
  • Bioequivalence록시나정(록시트로마이신)2015-12-29

    2 trial sites

  • Phase 3리아백스주(GV1001)2015-03-13

    16 trial sites

R&D and key agreements

Source: DART corporate disclosure

GV1001 (리아백스주) · 진행성 췌장암 · 임상 3상 완료 · Phase 3 licensed from controlling shareholder Gemvax & Kael. Trial report received Dec 2020, results presented at ASCO June 2021, papers published in Statistical Methods in Medical Research (Mar 2023) and BJC (Oct 2023). Conditional approval for Riabax has expired; new drug approval and commercialization under review.

GV1001 · 알츠하이머병 · 국내 임상 3상 준비중 · Exclusive license for clinical trials, approval, manufacturing and sales acquired from Gemvax & Kael in May 2023. MFDS approved the Phase 3 trial plan in Jan 2022 and a trial protocol amendment in Mar 2024.

GV1001 · 진행성핵상마비 · 2a상 완료, 조건부허가 신청, 2b/3상 예정 · License-in agreement with Gemvax & Kael signed Dec 2025 covering IP rights in 3 countries outside South Korea. Conditional approval filed with MFDS on Jan 20, 2026 based on Gemvax & Kael's Phase 2a results; Phase 2b/3 trials planned.

Not yet compiled: business overview. 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.

HYUNDAI PHARMACEUTICAL CO., LTD1 shared

KOSPI-listed pharma, food, and cosmetics company behind Diemduo dementia treatment and Miero Fiber drink (2.1bn+ bottles sold).

IL DONG PHARMACEUTICAL CO., LTD.100

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

Yuyu Pharma, Inc.100

Founded in 1941 and listed on the KOSPI in 1975, Yuyu Pharma is a pharmaceutical company with a co-promotion agreement with Dong-A ST for Tanamin.

ILDONG HOLDINGS CO.,LTD100

Founded in 1941 and listed on the KOSPI in 1975, Ildong Holdings is the holding company of the Ildong Pharmaceutical Group, overseeing pharmaceutical, aesthetic medical device, and drug development affiliates.

Medy-Tox Inc.99

Founded 2000, KOSDAQ-listed 2009, Medy-Tox develops and exports botulinum toxin biopharmaceuticals including Meditoxin and Innotox.

GC Biopharma Corp.97

KOSPI-listed comprehensive pharmaceutical company specializing in blood products and vaccines, with FDA-approved immunoglobulin ALYGLO.

BIO-FD&C CO.,LTD.85

Founded 2005, KOSDAQ-listed 2022, BIO-FD&C develops plant-cell platform-based cosmeceutical materials and biopharma pipelines.

DAEWON PHARMACEUTICAL CO.,LTD85

KOSPI-listed pharmaceutical company behind Coldwon cold medicine and Jangdaewon probiotics, developing a P-CAB drug pipeline.

SAMSUNG BIOLOGICS CO.,LTD.85

Founded 2011, listed 2016 — Samsung Biologics is a biopharma CDMO with 785,000L capacity across five Songdo plants.

GENOLUTION INC.85

Founded in 2006 and listed on KOSDAQ in 2020, Genolution is a molecular diagnostics and RNAi company producing nucleic acid extraction reagents and devices.

HANDOK Inc.85

KOSPI-listed comprehensive pharma company behind Amaryl diabetes drug and the USD 86.25M HL5101 anticancer out-license deal.

HL GENOMICS Co., Ltd.85

Sources and updates

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

This page is compiled from public sources without the company's involvement. If anything is inaccurate or incomplete, please let us know. Materials provided by the company are labelled as such.

Request a correction or addition