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Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 17 News #PharmaBuzz

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Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow
17 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

28 All APIs, 5 USDMF, 3 CEP/COS, 7 JDMF, 17 KDMF, 8 NDC API, 1 Listed APIs

28 All APIs
5 USDMF
3 CEP/COS
7 JDMF
17 KDMF
8 NDC API
1 Listed APIs

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INSPECTIONS & REGISTRATIONS

2 FDA, 1 GDUFA

inspections
2 FDA
1 GDUFA

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About

After returning from the USA in 1925, Dr. Ilhan New witnessed the hardship in his country under Japanese imperialism. He founded the Yuhan corporation in 1926 with the belief that only healthy people could reclaim their sovereignty and he sought to solve widespread public health problems. Over 80 years, the founding creed to make the best medicines and contribute to public health has been succeeded by us through our intense research and development activities and successful collaboration with multinational pharmaceutical companies. As a result, Yuhan is one of the most respected companies in Korea for 20 consecutive years, according to the annual Korean Management Association Consulting (KMAC) survey. Yuhan has been playing active role in global citizenship since its foundation in 1926. Even before global citizenship was conceptualized, Dr. New believed that was the duty and responsibility of business to develop itself for the prosperity of all society, and his own personal commitment to this was the donation of all of his personal property throughout his life up until his death. Yuhan is continuously making its social contribution by establishing a system where part of the company’s profits is returned to society. This endeavor has been domestically and internationally recognized through various organizations and publications. Yuhan has always emphasized research and development as its top corporate priority. The company approaches R&D through innovative, nimble and translational methodologies. This three-fold dynamic allows Yuhan to continue its over-arching commitment to enhancing quality of life. True to the company’s founding mission, Yuhan focuses its R&D efforts on developing the kinds of products people need most. By developing therapies for treating inflammatory, autoimmune, oncologic and metabolic diseases, Yuhan has significantly advanced the science and understanding of these prevalent disease processes. This rich body of knowledge and wealth of experience positions Yuhan on the cutting edge for developing unique, innovative, finished products and to partnering successfully with other developers. Yuhan has been playing active role in global citizenship since its foundation in 1926. Even before global citizenship was conceptualized, Dr. New believed that was the duty and responsibility of business to develop itself for the prosperity of all society, and his own personal commitment to this was the donation of all of his personal property throughout his life up until his death. Yuhan is continuously making its social contribution by establishing a system where part of the company’s profits is returned to society. This endeavor has been domestically and internationally recognized through various organizations and publications. The R&D Priority Yuhan has always emphasized research and development as its top corporate priority. The company approaches R&D through innovative, nimble and translational methodologies. This three-fold dynamic allows Yuhan to continue its over-arching commitment to enhancing quality of life. True to the company’s founding mission, Yuhan focuses its R&D efforts on developing the kinds of products people need most. By developing therapies for treating inflammatory, autoimmune, oncologic and metabolic diseases, Yuhan has significantly advanced the science and understanding of these prevalent disease processes. This rich body of knowledge and wealth of experience positions Yuhan on the cutting edge for developing unique, innovative, finished products and to partnering successfully with other developers. Yuhan: A Global Best Partner Equipped with state-of-the-art research capabilities and manufacturing facilities compliant with the United States Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMP) regulations, Yuhan is growing into a global pharmaceutical company that offers one-stop custom synthesis services from R&D to commercial production of active pharmaceutical products (APIs) and intermediates. Yuhan has undergone successful audits by many international regulatory agencies such as the FDA, the European Medicines Agency and the European Directorate for the Quality of Medicines (EMEA/EDQM), Australia’s Therapeutic Goods Amdinistration (TGA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). Yuhan has successfully provided high-quality APIs and intermediates for the following disease treatments: antivirals (HCV and HIV), antibiotics, antihistamines, antidiabetics, beta-lactamase inhibitors, CNS intermediates, and PEGylated compounds for international markets. Yuhan continues to expand its overseas markets by supplying finished products. The process began in 2010 with the out-licensing to China of Yuhan’s Revanex, the world’s first acid pump antagonist (APA). Revanex is now supplied world-wide to India, Southeast Asia, South America and the Middle East, improving the health and quality of life for individuals suffering from peptic ulcers and gastritis-related mucosal injury.

CPhI North America CPhI North America

Not Confirmed

Not Confirmed

20-22 May, 2025

Pennsylvania Conv Center, Philadelphia
STLE Annual MeetingSTLE Annual Meeting

Not Confirmed

Not Confirmed

18-22 May, 2025

Atlanta, Georgia
American Thoracic Soci...American Thoracic Society

Not Confirmed

Not Confirmed

18-21 May, 2025

San Francisco

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CONTACT DETAILS

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Country

South Korea

Address

74, Noryangjin-ro, Daebang-dong, Dongjak-gu, SEOUL

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+82-2-828-0181

enquiries@pharmacompass.com

Website

http://eng.yuhan.co.kr/Main/

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INTERVIEW #SpeakPharma

[Sponsored by another company]

Alchem NicSelect™ grants customers royalty-free access to T-MAX™ tech for 3-in-1 vape satisfaction in flavour-restricted markets

With increasing flavour bans in key markets, vaping brands are facing significant challenges in providing satisfying alternatives to vapers and smokers looking to transition. Recognising this need, Alchem NicSelect™ is making a bold move by offering its key customers royalty-free and unrestricted geographical access to its revolutionary T-MAX™ technology.“At Alchem NicSelect™, we understand the urgency for vaping brands to adapt to new regulations without compromising on satisfaction. By offering royalty-free access to T-MAX™ technology, we empower our customers to provide the closest cigarette-like experience possible, even in markets with strict flavour restrictions,” said Riccardo Santambrogio, Europe Sales Manager.HIGHLIGHTS// offering royalty-free access to T-MAX™ technology/ unrestricted geographical access/ closest cigarette-like experience Addressing the biggest barrier: Nicotine satisfactionOne of the primary reasons many vapers are dissatisfied and smokers struggle to switch to vaping is that traditional nicotine solutions fail to replicate the rapid satisfaction provided by cigarettes. Nicotine replacement therapies (NRTs) and even conventional vaping products often lack the immediate nicotine hit, throat feel, and overall experience that smokers are accustomed to. T-MAX™ solves this problem by engineering a nicotine experience that closely mimics cigarette consumption without relying on flavours.T-MAX™ provides a unique 3-in-1 approach:1. The Speed of a Cigarette – Rapid nicotine delivery and rush within seconds for immediate satisfaction.2. The Power of Nicotine Salts – A stronger perceived nicotine effect without exceeding legal limits (20 mg/ml nicotine limit under the European Tobacco Products Directive). With T-MAX™, 8 mg/ml feels like 20 mg/ml, and 14 mg/ml feels like 40 mg/ml.3. The Throat Hit of Freebase Nicotine – Especially in a flavour-free formulation, the combined ingredients in T-MAX™ deliver an even more satisfying throat feel than expected from nicotine base, much closer to and more familiar with a cigarette throat feel that habitual smokers recognise.HIGHLIGHTS// unique 3-in-1 approach/ rush within seconds/ stronger perceived nicotine effect without exceeding legal limits/ more satisfying throat feel that habitual smokers recogniseNo flavour, but not less satisfyingWhile flavours have traditionally played a role in vaping adoption, market realities are shifting. With flavour bans spreading across regions, brands need solutions that deliver satisfaction without relying on taste. Consumer research has shown that T-MAX™ performs exceptionally well even without added flavours. Since most cigarette smokers do not smoke for the tobacco flavour but rather for the nicotine hit and habitual experience, T-MAX™ provides a viable alternative that aligns with new regulatory landscapes.HIGHLIGHTS// flavour bans spreading across regions/ T-MAX™ performs exceptionally well even without added flavoursEmpowering vape brands with free access to T-MAX™By granting customers royalty-free access to the T-MAX™ technology, Alchem NicSelect™ is removing barriers for vaping brands and original equipment manufacturers (OEMs) looking to adapt to regulatory changes. This open-access approach ensures that manufacturers can integrate T-MAX™ into their product lines without additional costs, allowing them to offer superior nicotine satisfaction in markets where flavours are no longer an option.HIGHLIGHTS// removing barriers for vaping brands and OEMs looking to adapt/ manufacturers can integrate T-MAX™ into product lines without additional costsThe future of vaping in restricted marketsWith T-MAX™, the vaping industry has a powerful tool to retain customers and convert smokers who have struggled with traditional vaping products. By delivering the key elements of cigarette satisfaction — without combustion or flavours — T-MAX™ is set to redefine what a satisfying vape experience means in a post-flavour-ban world.“Our commitment to innovation and accessibility means we are providing our customers with the solutions they need to navigate an evolving regulatory landscape. T-MAX™ allows brands to offer a highly satisfying experience that mimics smoking without relying on flavours. The message is clear: no flavour, but not less satisfying”, added Santambrogio.HIGHLIGHTS// powerful tool to retain customers and convert smokers/ delivering the key elements of cigarette satisfaction without combustion or flavours/ no flavour, but not less satisfying

Impressions: 284

VLOG #PharmaReel

[Sponsored by another company]

Connecting People, Mentalities & Markets

This PharmaReel highlights Transo-Pharm USA’s offerings of premium Phyto Cannabidiol (CBD) and Phyto Cannabigerol (CBG) isolates from its cGMP-certified facility inspected by the FDA and ANVISA. The company has an expanded reach across the US and EU.

Impressions: 402

DATA COMPILATION #PharmaFlow

[Sponsored by another company]

DMF filings surge 44% in Q1 2025; India tops list with 51% rise in year-on-year submissions

The first quarter (Q1) of 2025 witnessed an impressive surge in Drug Master File (DMF) submissions to the US Food and Drug Administration (FDA), signaling a robust expansion in pharmaceutical development activities, the looming threat of tariffs notwithstanding.A total of 339 Type II DMFs were submitted during this period, as opposed to 235 submissions in Q1 2024, marking an exceptional increase of 44.26 percent. PharmaCompass’ data suggests that this is a record high for any first quarter.Overall, 440 DMFs were submitted across all categories (Types II, III, IV, and V) during Q1 2025, compared to 353 in the same period last year — representing a 24.65 percent increase.India and China continued to dominate the DMF landscape. India led with 162 submissions in Q1 2025, posting a remarkable 51.4 percent increase over 107 submissions recorded in Q1 2024. China followed with 135 submissions, representing a 33.66 percent increase over the 101 filings in Q1 2024.Taiwan sprung a surprise as a distant third. It made 12 DMF submissions in Q1 2025, as opposed to just one in Q1 2024. Western countries like the US, Spain, Germany, and Italy have maintained relatively stable or declining submission rates. Only the Netherlands showed significant growth with four DMF submissions in Q1 2025, up from zero in Q1 2024. View FDA DMF Filings in Q1 2025 (Power BI Dashboard, Free Excel Available)Indian giants MSN, Aurobindo, Cipla, Dr Reddy’s lead record-breaking DMF surgeIndia lived up to its “pharmacy of the world” reputation with the highest DMF submissions. In fact, seven of the top eight companies in the DMF tally were headquartered in India. MSN Group, emerged as the unequivocal leader with 23 submissions in Q1 2025, as against 15 in Q1 2024. Aurobindo Pharma increased its DMF activity from seven submissions in Q1 2024 to 12 in Q1 2025. Alivus Life Sciences, formerly known as Glenmark, made a dramatic leap with eight submissions in Q1 2025, quadrupling its previous year’s count of just two. Cipla more than doubled its DMF submissions — from three in Q1 2024 to eight in Q1 2025.Dr. Reddy’s Laboratories, one of India’s largest generic drugmakers, filed seven DMF submissions. The company’s Q1 2025 DMF portfolio includes high-value molecules like deucravacitinib, finerenone, enzalutamide, niraparib tosylate monohydrate, tucatinib, and tizanidine hydrochloride.Dr. Reddy’s has also indicated that they are open to manufacturing in the US. Meanwhile, Hetero Drugs filed seven submissions while Lee Pharma recorded six in Q1 2025.Chinese manufacturer Jiangsu East-Mab Biomedical Technology also established a significant presence with six DMFs. View FDA DMF Filings in Q1 2025 (Power BI Dashboard, Free Excel Available) Semaglutide, finerenone see most DMF submissions; first-time filings surge 64%Semaglutide and finerenone emerged as the most documented molecules in Q1 2025, each garnering nine DMF submissions. Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist that has revolutionized diabetes management and weight loss treatment, continues to attract significant manufacturer interest. Similarly, finerenone, a non-steroidal drug used in treating chronic kidney disease in type 2 diabetes patients, has garnered attention from manufacturers.Carfilzomib, used in multiple myeloma treatment, secured the third position with five DMF submissions. Deucravacitinib, a novel drug approved for moderate to severe plaque psoriasis, followed with four DMF submissions.There were several molecules with three DMF submissions each. Among them were tapinarof, a novel drug for psoriasis, and tirzepatide, a GLP-1/GIP receptor agonist that has shown remarkable efficacy in diabetes and weight management. During the quarter, 23 molecules received their inaugural DMF submissions. This number has risen by 64 percent since Q1 2024, when only 14 drugs saw their first DMF filings.In Q1 2025, these 23 first-time molecules collectively garnered 30 DMF submissions, with deucravacitinib emerging as the clear leader. Indian companies Dr. Reddy’s Laboratories and Cipla filed DMFs for this plaque psoriasis treatment as did Spain’s Curia and PMC Global.The Q1 2025 roster of first-time DMF filings include retatrutide (another GLP-1 receptor agonist), sotagliflozin, setmelanotide acetate, daridorexant, nusinersen, zavegepant, belzutifan, elacestrant dihydrochloride, selumetinib sulfate, sotorasib, atogepant, omadacycline tosylate, osilodrostat phosphate, ensifentrine, landiolol hydrochloride, maralixibat chloride, maribavir, methyl olivetolate, diazoxide choline, sparsentan, thinnertide, and vismodegib. View FDA DMF Filings in Q1 2025 (Power BI Dashboard, Free Excel Available) Our viewGiven Trump’s rhetoric around tariffs on imported drugs, the record-breaking DMF submissions in Q1 2025 sent out a strong message that the global pharmaceutical industry is willing to take on the complex geopolitical situation with resilience and strategic foresight.On a different note, the rise in DMF filings also indicate increased workload for the FDA staff, as also more inspections by the agency. It seems like more ‘laid off’ FDA employees will be asked to return to work in the coming days.