SAMIL PHARMACEUTICAL CO.,LTD
Founded in 1947 and listed on the KOSPI in 1985, Samil Pharmaceutical focuses on ophthalmology, liver disease, and gastrointestinal prescription drugs, and operates a global ophthalmic CDMO plant in Vietnam.
As of 2026-10-10, SAMIL PHARMACEUTICAL CO.,LTD has 1 Korean MFDS device approval, 162 Korean MFDS drug approvals, 7 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).
Price
Change
Market cap
Business overview
Source: DART corporate disclosureSamil Pharmaceutical was founded in 1947 and listed on the KOSPI in 1985 as a pharmaceutical manufacturing and sales company. It is known for products such as Children's Brufen Syrup, Tearsil Once, and Eyetuomini, and focuses on prescription drugs for ophthalmology, liver disease, and gastrointestinal conditions, combining licensed-in production of original drugs, direct development/manufacturing/sales of generics and improved new drugs (product sales), and direct import and exclusive domestic distribution of original products (merchandise sales). In 2025, consolidated revenue was KRW 210.3 billion, with the pharmaceutical segment accounting for 97.8% and other segments 2.2%, and its Vietnam subsidiary completed a global ophthalmic CDMO plant meeting cGMP and EU-GMP standards in November 2022.
Products & technology
- 어린이부루펜시럽
- 티어실원스
- 아이투오미니
Regulatory approvals
data.go.kr162 Korean MFDS drug approvals · 1970–2026 / 1 Korean MFDS device approvals · 2002
- MFDS drugTego-S Tab. 25mg2026-08-11Drug · Prescription · Approval202602338
- MFDS drugTego-S Tab. 50mg2026-08-11Drug · Prescription · Approval202602339
- MFDS drugActiflu Cough Soft Cap.2026-08-03Drug · OTC · Notification202602238
- MFDS drugActiflu Cold Soft Cap.2026-07-27Drug · OTC · Notification202602160
- MFDS drugLACURE Mini Eye Drops 0.15% (Sodium Hyaluronate)2026-06-29Drug · Prescription · Approval202601845
- MFDS drugALTSDUO Tab.2026-03-05Drug · Prescription · Approval202600663
- MFDS drugElafree2026-01-13Drug · Prescription · Approval202600113
- MFDS drugTofajakt Tab. 10mg2025-11-20Drug · Prescription · Approval202503025
- MFDS drugOnedopa Tab. 12.5/50mg2025-09-24Drug · Prescription · Approval202502527
- MFDS drugOnedopa Tab. 25/100mg2025-09-24Drug · Prescription · Approval202502528
- MFDS drugOnedopa Tab. 50/200mg2025-09-24Drug · Prescription · Approval202502529
- MFDS drugActiflunose Caps.2025-06-30Drug · OTC · Notification202501617
Show 68 more
- MFDS drugRevaG SR Tablet 150mg2025-05-28Drug · Prescription · Approval202501331
- MFDS drugLecox tab.2023-08-10Drug · Prescription · Approval202302412
- MFDS drugTenoS Tablet2023-03-15Drug · Prescription · Approval202300928
- MFDS drugJaklin Tab. 5mg2022-07-05Drug · Prescription · Approval202202794
- MFDS drugRevaK Eyedrops2022-06-16Drug · Prescription · Approval202202522
- MFDS drugSandoz Sugammadex Sodium Injection2022-01-20Drug · Prescription · Approval202200335
- MFDS drugEYE2O Mint Eye Drops2021-07-13Drug · OTC · Notification202105312
- MFDS drugNEWCOXIA Tab. 30mgRevoked2021-03-25Drug · Prescription · Approval202102620
- MFDS drugLeflu Tab. 10mg2020-12-22Drug · Prescription · Approval202009077
- MFDS drugLeflu Tab. 20mg2020-12-22Drug · Prescription · Approval202009078
- MFDS drugIcure Ophthalmic DropsRevoked2020-11-09Drug · Prescription · Approval202007661
- MFDS drugEYE2O Blue Eye DropsRevoked2020-09-08Drug · OTC · Notification202006233
- MFDS drugOculevo Ophthalmic Drops 1.5%2020-05-26Drug · Prescription · Notification202003807
- MFDS drugLacure Ophthalmic Drops 0.3%2020-05-21Drug · Prescription · Approval202003717
- MFDS drugAroda Cap.Revoked2020-05-15Drug · Prescription · Approval202003529
- MFDS drugOCUOLO Ophthalmic drops 0.7%2020-04-29Drug · Prescription · Approval202003228
- MFDS drugPolymac Tab.2020-02-21Drug · Prescription · Approval202001272
- MFDS drugSislin Soft Cap.2020-01-29Drug · OTC · Notification202000474
- MFDS drugAlzarl Tab. 10mg2019-11-27Drug · Prescription · Notification201908132
- MFDS drugAlzarl Tab. 5mg2019-11-20Drug · Prescription · Notification201908003
- MFDS drugGilect Tab. 0.5mg2019-10-22Drug · Prescription · Approval201907386
- MFDS drugGilect Tab. 1mg2019-10-22Drug · Prescription · Approval201907387
- MFDS drugGABELIN Tab. 50mg2019-07-29Drug · Prescription · Approval201905357
- MFDS drugGABELIN Tab. 25mg2019-07-29Drug · Prescription · Approval201905358
- MFDS drugTwolion Ophthalmic Drops2019-07-24Drug · Prescription · Approval201905273
- MFDS drugRAVE Tab.Revoked2019-05-31Drug · Prescription · Notification201903620
- MFDS drugOcuporine Ophthalmic Drops 0.05%Revoked2019-05-20Drug · Prescription · Approval201903227
- MFDS drugEntapone Tab. 200mgRevoked2019-04-25Drug · Prescription · Approval201902599
- MFDS drugTIERSIL Aerosol2018-11-28Drug · OTC · Notification201804704
- MFDS drugDualkopt Eye Drops2018-10-31Drug · Prescription · Approval201804301
- MFDS drugPrapexole ER Tab. 0.75mg2018-10-31Drug · Prescription · Approval201804306
- MFDS drugPrapexole ER Tab. 1.5mg2018-10-31Drug · Prescription · Approval201804307
- MFDS drugPrapexole ER Tab. 0.375mg2018-10-31Drug · Prescription · Approval201804308
- MFDS drugDoxilium Tab. 500mg2018-01-15Drug · Prescription · Approval201800205
- MFDS drugMONOPROST Eye Drops2017-12-18Drug · Prescription · Approval201708384
- MFDS drugLinoped Tab.2017-08-11Drug · Prescription · Approval201706560
- MFDS drugGABELIN Tab. 150mg2017-07-20Drug · Prescription · Approval201705789
- MFDS drugGABELIN Tab. 75mg2017-07-20Drug · Prescription · Approval201705790
- MFDS drugAcefen Tab.2017-03-28Drug · Prescription · Approval201701471
- MFDS drugTIERSIL Cool Cream2016-05-30Drug · OTC · Notification201603039
- MFDS drugErecximum ODF 20mg2015-07-13Drug · Prescription · Approval201504798
- MFDS drugExozole Tab. 20mg2015-06-29Drug · Prescription · Approval201504200
- MFDS drugExozole Tab. 40mg2015-06-29Drug · Prescription · Approval201504201
- MFDS drugEommason Syrup2015-04-15Drug · OTC · Notification201502255
- MFDS drugSandoz Escitalopram FCT 5mg2015-02-27Drug · Prescription · Approval201501051
- MFDS drugLividi Cap.2015-01-27Drug · Prescription · Approval201500401
- MFDS drugTrinity White Gel2014-12-15Drug · Prescription · Notification201405890
- MFDS drugSandoz Escitalopram FCT 15mg2014-04-14Drug · Prescription · Approval201401785
- MFDS drugSandoz Escitalopram FCT 20mg2014-04-14Drug · Prescription · Approval201401786
- MFDS drugEperione Tab.2013-08-05Drug · Prescription · Approval201308671
- MFDS drugEnped Tab. 1mg2012-09-24Drug · Prescription · Approval201206904
- MFDS drugEnped Tab. 0.5mg2012-09-24Drug · Prescription · Approval201206905
- MFDS drugMelodex Cap. 15mg2012-09-21Drug · Prescription · Approval201206872
- MFDS drugPrapexole Tab. 0.125mg2012-09-20Drug · Prescription · Approval201206856
- MFDS drugPrapexole Tab. 0.5mg2012-09-20Drug · Prescription · Approval201206857
- MFDS drugPrapexole Tab. 0.25mg2012-09-20Drug · Prescription · Approval201206858
- MFDS drugSandoz Sertraline FCT 100mg2012-09-17Drug · Prescription · Approval201206823
- MFDS drugMelodex Cap. 7.5mg2012-09-11Drug · Prescription · Approval201206751
- MFDS drugPrapexole Tab. 1mg2012-02-28Drug · Prescription · Approval201201265
- MFDS drugHyabak Eye Drops2011-09-30Drug · Prescription · Approval201107545
- MFDS drugEYE2O Mini Eye Drop2011-08-22Drug · OTC · Notification201105482
- MFDS drugTELMIS Plus Tab. 80/25mg2010-09-30Drug · Prescription · Notification201005770
- MFDS drugAlinol Ophthalmic Drops2010-06-29Drug · Prescription · Approval201004240
- MFDS drugTELMIS Tab. 40mg2010-02-25Drug · Prescription · Notification201001683
- MFDS drugTELMIS Tab. 80mg2010-02-25Drug · Prescription · Notification201001685
- MFDS drugTELMIS Plus Tab. 80/12.5mg2010-01-29Drug · Prescription · Notification201001021
- MFDS drugTELMIS Plus Tab. 40/12.5mg2010-01-29Drug · Prescription · Notification201001022
- MFDS drugRovitan Tab. 20mg2010-01-28Drug · Prescription · Approval201001006
Showing the 80 most recent of 163 records.
Clinical trials
data.go.kr25 MFDS clinical trial authorisations · 2014–2025 (Bioequivalence 23 · Phase 1 2)
- Bioequivalence사피온정50밀리그램(사피나미드메실산염)2025-11-12
2 trial sites
- Bioequivalence보넥타정20밀리그램2025-09-01
2 trial sites
- Bioequivalence프라펙솔정0.25밀리그램(프라미펙솔염산염일수화물)2025-01-10
2 trial sites
- Bioequivalence포리부틴드라이시럽2024-08-26
2 trial sites
- BioequivalenceSI-BL2002023-07-10
2 trial sites
- Bioequivalence엔페드정1밀리그램(엔테카비르)2023-04-17
2 trial sites
- Bioequivalence알잘정10밀리그램(아로티놀롤염산염)2023-02-17
2 trial sites
- Bioequivalence포리부틴서방정(트리메부틴말레산염)2022-11-21
2 trial sites
- Bioequivalence포리부틴서방정(트리메부틴말레산염)2022-11-03
2 trial sites
- Bioequivalence가벨린서방정165밀리그램2021-09-02
1 trial site
- Bioequivalence가벨린서방정165밀리그램2021-09-01
1 trial site
- Bioequivalence프라펙솔서방정0.375밀리그램(프라미펙솔염산염일수화물)2020-05-14
2 trial sites
Show 13 more
- Bioequivalence프라펙솔서방정0.375밀리그램(프라미펙솔염산염일수화물)2020-05-08
2 trial sites
- Bioequivalence프라펙솔정0.25밀리그램(프라미펙솔염산염일수화물)2019-11-06
2 trial sites
- Bioequivalence길렉트정(라사길린메실산염)2018-08-27
2 trial sites
- Bioequivalence엔타폰정(엔타카폰200mg)2018-03-16
2 trial sites
- Bioequivalence프라펙솔서방정0.375밀리그램(프라미펙솔염산염일수화물)2017-07-17
2 trial sites
- Bioequivalence삼일 BDD&마늘유 복합정(가칭)2016-07-13
2 trial sites
- Bioequivalence가벨린정150mg(프레가발린)2016-06-24
2 trial sites
- Bioequivalence플루진현탁용분말6mg/mL(오셀타미비르인산염)2015-11-26
2 trial sites
- Bioequivalence삼일 텔미사르탄80mg암로디핀5mg복합제(가칭)2015-07-22
2 trial sites
- Bioequivalence라노졸정2015-06-23
2 trial sites
- Phase 1SI-13022014-05-30
1 trial site
- Phase 1SI-13072014-05-30
1 trial site
- Bioequivalence엑소졸정 40mg2014-03-19
2 trial sites
Global clinical trials
ClinicalTrials.gov · sponsor-matchedPhase 1 · Completed · 2014-05 · NCT02579356
R&D and key agreements
Source: DART corporate disclosureAramchol · 비알콜성지방간염(NASH) · 임상3상 · Licensed from Galmed Research and Development on 2016-07-28; Samil holds Korean sales rights for 20 years after first domestic launch; total milestone payments up to US$8,089,473 (US$3,589,473 paid to date as upfront and milestones).
Lorecivivint (SM04690) · 골관절염 · 임상3상 · Licensed from Biosplice Therapeutics, Inc (formerly Samumed) on 2021-03-31; total milestone payments up to US$10,000,000 (US$3,000,000 paid as upfront).
Key disclosures
KRX KIND via OpenDARTPublications
PubMed · affiliation-matched- Epidemiology and clinical outcomes of von Hippel-Lindau disease in Korea: a nationwide cohort study.
Scientific reports · 2026-07 · Choi SW, Shin SJ, Joo K 외 5
- Anthropometric Changes and Risk of Visual Impairment in Patients with Newly Diagnosed Type 2 Diabetes Mellitus.
Diabetes & metabolism journal · 2025-11 · Ha A, Shin S, Lee J 외 2
- The Effects of Sulglycotide on the Adhesion and the Inflammation of Helicobacter Pylori.
International journal of environmental research and public health · 2020-04 · Yang JY, Kim P, Jeong SH 외 4
- Epigalloccatechin-3-gallate inhibits ocular neovascularization and vascular permeability in human retinal pigment epithelial and human retinal microvascular endothelial cells via suppression of MMP-9 and VEGF activation.
Molecules (Basel, Switzerland) · 2014-08 · Lee HS, Jun JH, Jung EH 외 2
- Standardized Salvia miltiorrhiza extract suppresses hepatic stellate cell activation and attenuates steatohepatitis induced by a methionine-choline deficient diet in mice.
Molecules (Basel, Switzerland) · 2014-06 · Lee HS, Son WC, Ryu JE 외 2
- Development of novel itraconazole-loaded solid dispersion without crystalline change with improved bioavailability.
Archives of pharmacal research · 2010-08 · Park YJ, Xuan JJ, Oh DH 외 6
- Physicochemical characterization of tacrolimus-loaded solid dispersion with sodium carboxylmethyl cellulose and sodium lauryl sulfate.
Archives of pharmacal research · 2009-06 · Park YJ, Ryu DS, Li DX 외 8
Patents
KIPRIS · applicant-matchedRegistered · 2023-02 · Application 1020230018670
Registered · 2022-07 · Application 1020220085243
PCT · Published · 2020-10 · Application PCT/KR2020/014167
PCT · Published · 2019-11 · Application PCT/KR2019/016503
Registered · 2019-11 · Application 1020190154796
Registered · 2019-10 · Application 1020190132929
Withdrawn · 2018-11 · Application 1020180150009
Withdrawn · 2018-03 · Application 1020180033939
Registered · 2016-07 · Application 1020160095369
Registered · 2016-03 · Application 1020160026301
Show 31 more patents
Registered · 2012-10 · Application 1020120114062
Registered · 2012-07 · Application 1020120079809
Registered · 2011-02 · Application 1020110013635
Registered · 2010-07 · Application 1020100068304
PCT · Published · 2010-05 · Application PCT/KR2010/003150
Registered · 2010-04 · Application 1020100033852
Registered · 2010-04 · Application 1020100033850
PCT · Published · 2010-03 · Application PCT/KR2010/001713
Rejected · 2010-03 · Application 1020100024753
Registered · 2010-01 · Application 1020100002507
Registered · 2009-12 · Application 1020090125901
Registered · 2009-12 · Application 1020090125899
PCT · Published · 2009-12 · Application PCT/KR2009/007212
PCT · Published · 2009-12 · Application PCT/KR2009/007215
PCT · Published · 2009-10 · Application PCT/KR2009/006323
Withdrawn · 2009-07 · Application 1020090070578
Withdrawn · 2009-07 · Application 1020090070575
Registered · 2009-06 · Application 1020090054809
Registered · 2009-03 · Application 1020090025399
Rejected · 2009-02 · Application 1020090015368
Withdrawn · 2009-02 · Application 1020090014165
Rejected · 2008-12 · Application 1020080127780
Rejected · 2008-12 · Application 1020080125181
Registered · 2008-12 · Application 1020080124068
Rejected · 2008-05 · Application 1020080050625
Registered · 2008-02 · Application 1020080011139
Expired · 2006-05 · Application 2020060013948
Expired · 1996-02 · Application 1019960005073
Expired · 1988-03 · Application 1019880002512
Expired · 1988-03 · Application 1019880002511
Expired · 1988-03 · Application 1019880002510
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How to connect (MCP)Companies approved for the same productsPharma & CDMO
Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.
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KOSPI-listed comprehensive pharmaceutical company specializing in blood products and vaccines, with FDA-approved immunoglobulin ALYGLO.
KOSPI-listed pharmaceutical company behind Coldwon cold medicine and Jangdaewon probiotics, developing a P-CAB drug pipeline.
Founded 2011, listed 2016 — Samsung Biologics is a biopharma CDMO with 785,000L capacity across five Songdo plants.
Founded in 2006 and listed on KOSDAQ in 2020, Genolution is a molecular diagnostics and RNAi company producing nucleic acid extraction reagents and devices.
Ahn-Gook Pharmaceutical sells the cough/expectorant drug Sinecuran and the eye-health supplement Tobicom.
Founded in 2003 and listed on KOSDAQ in 2015, Corestem Chemon develops stem cell therapies and provides nonclinical CRO services, including the ALS treatment Neuronata-R.
Founded 2005, KOSDAQ-listed 2022, BIO-FD&C develops plant-cell platform-based cosmeceutical materials and biopharma pipelines.
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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