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Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 6 News #PharmaBuzz

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

ACTIVE PHARMA INGREDIENTS

4 All APIs, 4 USDMF

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FINISHED DOSAGE FORMULATIONS

9 FDF Dossiers, 5 FDA Orange Book, 4 Europe

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About

1847 Komatsuya founded (Nihei Hisamitsu) 1869 KISHINTAN launched 1871 The company name, Komatsuya, changed to Hisamitsu Joeido (Yoichi Hisamitsu) 1903 Hisamitsu & Co. (Saburo Nakatomi) established ASAHI MANKINKO® launched 1907 KAIFUKUGAN® launched 1934 SALONPAS® launched 1944 Hisamitsu＆Co. played a leading role in the incorporation of Miyaki Seiyaku Co. 1951 Hisamitsu＆Co. incorporated (Masayoshi Nakatomi) 1952 Osaka Representative Office (current Osaka Branch) established 1957 Tokyo Representative Office (current Tokyo Head Office and Branch) established 1960 Taiwan Hisamitsu Pharmaceutical Co., Ltd. (current Taipei Branch) established 1962 The company’s stocks listed in the Second Section of the Tokyo Stock Exchange; Shares listed on the Fukuoka Stock Exchange 1963 AIR® SALONPAS launched 1964 Shares listed in the Second Section of the Osaka Stock Exchange 1965 The company renamed Hisamitsu Pharmaceutical Co., Inc. 1966 Nagoya Representative Office (currently Nagoya Branch) established 1968 SALONPAS® E launched 1970 Sapporo Representative Office (current Sapporo Branch) established 1971 SALONSIP® launched Shares listed in the Second Section of the Nagoya Stock Exchange Construction of the Tosu Laboratories completed Sendai Representative Office (current Sendai Branch) established 1972 Section to the First Section of the Tokyo Shares shifted from the Second Stock Exchange, Osaka Stock Exchange and Nagoya Stock Exchange PAPSALON® launched 1975 P.T. Salonpas Indonesia established 1978 PAPSALON® G launched 1981 Masayoshi Nakatomi became a Chairman of the Board of Directors and Hirotaka Nakatomi took a charge of president & CEO 1982 SALONPAS-HI® launched 1983 Takamatsu Representative Office (current Takamatsu Branch) established Hiroshima Representative Office (current Hiroshima Branch) established 1984 VESICUM® (cream and ointment) launched 1985 SALONPAS® A launched 1986 Hisamitsu Farmaceutica do Brazil Ltda. established SALONPAS® 30 launched ANAAKI SALONPAS® A (Porous SALONPAS® A) launched SECTOR® GEL launched 1987 Hisamitsu America, Inc. established NOBINOBI® SALONSIP® launched Construction of Utsunomiya Factory completed 1988 The Nakatomi Foundation for Promotion of Health Science established MOHRUS® launched 1989 Hisamitsu’s corporate new logo used SECTOR® (cream and lotion) launched 1990 Construction of Tsukuba Laboratories completed Nakatomi Memorial Foundation established 1991 AIR® SALONPAS® EX launched 1992 VOLLEY® (cream and lotion) launched 1993 SALONSIP® HEAD PAD launched 1994 Hisamitsu’s corporate logo changed Hisamitsu KBC Augusta Golf Tournament held Hisamitsu Vietnam Pharmaceutical Co., Ltd. established 1995 Nakatomi Memorial Medicine Museum opened Operations at the Factory in Vietnam started MOHRUS® TAPE launched 1997 SALONPAS® Ae launched 1998 California Laboratories established London Representative Office (current Hisamitsu UK Ltd.) established Kumamoto Sales Office (current Kumamoto Branch) established La SALONPAS® launched Lifecella® Face Mask® launched NOBINOBI® SALONSIP® -α launched 1999 Acquires ISO 14001 Certification (Kyushu Head Office) 2000 Kyoto Sales Office (currently Kyoto Branch) established ESTRANA® launched Acquired ISO 14001 Certification (Utsunomiya Factory) 2001 Tokyo Head Office relocated to Marunouchi,Tokyo 2002 Operations at Manaus Factory in Brazil started MOHRUS® TAPE L launched Malaysia Representative Office (current Singapore Branch) established Lifecella® Essence Sheet Mask launched Hisamitsu UK Ltd. established 2003 Hisamitsu’s corporate logo changed BUTENALOCK® launched FEITAS® launched FLEX® launched Taipei Branch established 2004 The honorary consulate of Brazil opened. AIR® SALONPAS® Indomethacin 1.0% launched 2005 New Jersey Representative Office established Hisamitsu took over the ethical drugs division from SSP co.,Ltd (Hisamitsu Medical Co., Ltd. founded) MOHRUS® 60 launched KEPLAT® launched in Italy MOHRUS® PATCH launched in Hong Kong SALONPAS World Ladies Golf Tournament (currently LPGA Tour World Ladies Championship SALONPAS CUP) held SALONSIP® L launched 2006 Kagoshima Branch established Roma Representative Office (integrated with Hisamitsu UK Ltd.) established Lifecella® Gel Mask launched NOBINOBI® SALONSIP® S launched FEITAS® (lotion, cream and tick) launched TULOBUTEROL TAPE “HMT” launched NABOAL® PAP launched NABOAL® TAPE L launched 2007 Hisamitsu celebrated the 160th anniversary of the company’s founding Lifecella® Milky Lotion Sheet Mask launched FEITAS® L launched Singapore Branch established SALONPAS® LOTION launched Construction of the Utsunomiya Second Factory completed FEITAS® HOT launched CSR Promotion Office established The NAS Battery System inplemented 2008 SALONPAS® PAIN RELIEF PATCH was approved by the US-FDA BUTENALOCK® V launched AIR® SALONPAS® DX launched GAN RYO JUN® launched SALONPAS® EX launched FEITAS® L HOT launched FEITAS® (gel, tick and gel-patch) launched Lifecella® Essence Mask (3 items) launched 2009 Lifecella® Eye Mask (3 items) launched Hisamitsu® ICING SHEET launched AIR® SALONPAS® ICING SPRAY launched CHOLESTON® launched FEITAS® Z (tape, gel-patch and gel) launched Hisamitsu U.S., Inc.established Noven Pharmaceuticals, Inc. (U.S.A.) integrated FEITAS® SIP HOT launched SALONPAS® EX HOT launched 2010 BUTENALOCK® V AIR® SOKAI POWDER launched Hisamitsu® ICE TOWEL launched Fentany Transdermal System launched in the U.S FENTOS® TAPE launched

DCAT WeekDCAT Week

Not Confirmed

Not Confirmed

17-20 March, 2025

New York, USA
World ADC LondonWorld ADC London

Not Confirmed

Not Confirmed

03-06 March, 2025

London, UK
RNA LeadersRNA Leaders

Not Confirmed

Not Confirmed

04-06 March, 2025

Basel, Switzerland

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CONTACT DETAILS

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Country

Japan

Address

Kyushu Head Office (Registered head office) Saga, Tosu, Tashirodaikan-machi 40...

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+81-(0)3-5293-1720

enquiries@pharmacompass.com

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https://www.hisamitsu.co.jp/english/

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INTERVIEW #SpeakPharma

[Sponsored by another company]

“Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

This week, SpeakPharma interviews Denise Sutton, Chief Operating Officer and Site Head at Quotient Sciences’ Nottingham facility in the UK. Quotient Sciences is a drug development and manufacturing accelerator that offers the innovative Translational Pharmaceutics platform to support customers in overcoming drug development challenges. Sutton has been with the company for over 25 years. In this interview, she provides insights into the evolution of Quotient Sciences’ Nottingham facility and discusses how the organization has transformed from a small 10-bed clinic to a comprehensive drug development campus with six GMP suites. She also shares her perspective on the company’s unique approach to integrating drug development services. HIGHLIGHTS// evolution of Quotient Sciences’ Nottingham facility/ unique approach to integrating drug development services How has the Nottingham site transformed from when it was founded, to what it is today? Initially, we were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90 percent of our work focused on gamma scintigraphic imaging (a diagnostic test that creates images of the body’s internal organs and tissues using gamma rays). Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed. At the end of 1999, we moved our headquarters to a purpose-built, two-storey facility—now known as Trent House on our now much larger Nottingham campus. We built three good manufacturing practice (GMP) suites on the top floor and three clinical wards on the bottom floor. These were very early days that marked the start of our Translational Pharmaceutics platform. We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, when we approached the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies, but do so for conventional drug development, without the radiolabel. We explored the application of ICH Q8 Quality by Design (QbD) guidelines to introduce a compositional design space into the CMC section of our regulatory dossier. This officially created a methodology for applying the Translational Pharmaceutics platform, and we haven't looked back since. Today, we have expanded substantially. Our Nottingham site is a campus of five buildings. We have development and analytical labs, six GMP suites, six clinical wards with a total of 85 beds (where we conduct healthy volunteer phase 1 clinical studies), and many talented colleagues covering our spectrum of CRO and CDMO services. HIGHLIGHTS// officially created a methodology for applying the Translational Pharmaceutics platform/ development and analytical labs/ six GMP suites How is Translational Pharmaceutics applied to drug development programs? We apply Translational Pharmaceutics across three core applications: first-in-human clinical studies, drug product optimization programs through rapid formulation development and clinical testing, and as a part of human ADME (absorption, distribution, metabolism, and excretion) programs. No matter how a client chooses to work with us to apply Translational Pharmaceutics, the benefits of using a single organization and project management team to integrate services lets our clients remain in control and one step ahead of the emerging data that impacts the success of their molecule. Over all these years, our flagship Translational Pharmaceutics platform for drug development has remained unchanged in the way it empowers our customers and offers them unparalleled flexibility. HIGHLIGHTS// three core applications/ benefits of using a single organization/ clients remain in control What would you say are the key strengths of Quotient Sciences’ Nottingham site? How do you support customer programs? Nowhere else would a single project manager oversee such a broad spectrum of activities, let alone be expected to ensure seamless, timely progression across functions that in any other company (i.e. at other CDMOs or CROs) would be delivered through multiple operating areas or through the use of a combination of third-party vendors. The project managers do face challenges. But by working with the project team, they are able to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers. A project Gantt chart is our project management team’s guiding light. I believe our project management team is truly world-leading – they communicate well, show great compassion, and lead with integrity. I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, and work collaboratively to deliver the best possible service. After 25 years at Quotient, I continue to really enjoy going to work. I am indebted to various colleagues for helping me continue to feel this way. HIGHLIGHTS// project management team is truly world-leading/ high-performing, supportive, cross-functional teams/ 25 years at Quotient

Impressions: 5476

VLOG #PharmaReel

[Sponsored by another company]

Leading CDMO & API Platform

DATA COMPILATION #PharmaFlow

[Sponsored by another company]

Top first-in-class drug candidates of 2025: Ionis’ donidalorsen, Sanofi’s fitusiran, Cytokinetics’ aficamten await FDA approval

First‑in‑class drugs are therapies with entirely new approaches that improve patient outcomes and fundamentally change treatment paradigms.This week, PharmaCompass brings a compilation of 2025’s most promising first-in-class drug candidates. With their US Food and Drug Administration (FDA) action dates in 2025, many of these drugs, once approved, hold the potential of becoming blockbusters.Ionis’ donidalorsen, Sanofi’s fitusiran, Cytokinetics’ aficamten poised to transform patient careIonis’ donidalorsen is an exciting candidate designed to tackle hereditary angioedema (HAE), a rare condition marked by unpredictable and potentially life‑threatening swelling episodes.This novel antisense oligonucleotide works by “silencing” the messenger RNA that codes for prekallikrein — a protein that triggers inflammation leading to swelling. Instead of blocking a protein once it’s made, donidalorsen stops the cell from producing it in the first place. This precision approach could mean fewer infusions and reduced side effects compared to traditional treatments.Another promising candidate is Sanofi and Alnylam Pharmaceuticals’ fitusiran. It employs the technology of small interfering RNA (siRNA) to lower levels of antithrombin — a natural protein that, when in excess, can impair the blood’s ability to clot. By reducing antithrombin, fitusiran rebalances the blood’s clotting process in patients with hemophilia A and B.Similarly, Cytokinetics’ aficamten is designed to treat obstructive hypertrophic cardiomyopathy (oHCM), a condition in which the heart muscle becomes abnormally thick, obstructing blood flow. Aficamten works by inhibiting cardiac myosin, a protein that drives heart muscle contraction. This helps relieve symptoms like shortness of breath and chest pain. If approved, aficamten is expected to rake in annual sales of US$ 2.8 billion by 2030.UroGen, J&J’s candidates eye US$ 5 bn markets; AbbVie, Summit’s meds target lung cancerUroGen Pharma’s UGN‑102 is poised to redefine the treatment of non‑muscle‑invasive bladder cancer. This innovative formulation uses a reverse thermal gel technology that transforms from a liquid into a gel once inside the bladder. This change ensures that the chemotherapeutic agent, mitomycin, remains in contact with the bladder lining for a longer period, increasing its effectiveness at eradicating cancer cells and reducing the risk of recurrence.For patients, UGN‑102 could mean a non‑surgical, outpatient treatment option that is less invasive than traditional surgical methods. If approved, UGN-102 could address a US market of approximately 82,000 patients annually, translating into a market opportunity exceeding US$ 5 billion, according to company estimates.Johnson & Johnson’s nipocalimab is a new treatment aimed at helping people with autoimmune diseases — a group of conditions where the body’s defense system mistakenly attacks its own healthy cells. Nipocalimab works by blocking the neonatal Fc receptor (FcRn), thereby lowering the levels of pathogenic antibodies that drive many autoimmune disorders. J&J had acquired this FcRn blocker in 2020 as part of its US$ 6.5 billion takeover of Momenta Pharmaceuticals. J&J is trialing the drug in as many as 10 indications and expects peak annual sales in excess of US$ 5 billion.AbbVie’s antibody-drug conjugate (ADC), telisotuzumab vedotin, is designed as a “guided-missile” to deliver toxic drugs directly to cancer cells while sparing healthy tissues. Telisotuzumab vedotin targets c‑Met, a receptor that is over-expressed in certain cancers such as non‑small cell lung cancer (NSCLC). There are currently no approved anti-cancer therapies specifically for c-Met over-expressing NSCLC.Summit Therapeutics’ ivonescimab is a cutting‑edge bispecific antibody designed specifically for NSCLC. Unlike traditional therapies that target a single molecule, ivonescimab binds simultaneously to a tumor-specific antigen on cancer cells and to a receptor on T cells, effectively bringing these two together so the body’s own immune system can recognize and attack the tumor. This dual engagement strategy helps overcome common mechanism tumors.Insmed’s Brensocatib is an innovative, first‐in‐class oral inhibitor of dipeptidyl peptidase‑1 (DPP‑1) that targets a key step in the inflammatory cascade. DPP‑1 is responsible for activating neutrophil serine proteases — enzymes that, when overactive, can cause significant lung tissue damage in conditions such as non‑cystic fibrosis bronchiectasis. Brensocatib is expected to clock annual sales of US$ 2.8 billion by 2030.Gepotidacin, an investigational antibiotic developed by GSK, is poised to make a significant impact in the treatment of uncomplicated urinary tract infections (uUTIs) and urogenital gonorrhea. If approved, it would be the first oral antibiotic in a new class for uUTIs in over two decades.Arrowhead, Regenxbio, Ultragenyx address rare, genetic diseasesArrowhead Pharmaceuticals is developing an innovative gene-targeting therapy — plozasiran. This drug uses RNA interference (RNAi) to interrupt the gene responsible for producing apolipoprotein C‑III (APOC3), a protein that regulates blood triglyceride levels. For people with severe hypertriglyceridemia or familial chylomicronemia syndrome (FCS) — a severe and rare genetic disease for which there are currently no FDA‑approved treatments — high triglyceride levels can lead to pancreatitis and other serious cardiovascular issues. Regenxbio’s RGX‑121 is a one‑time gene therapy candidate for Hunter syndrome (MPS 2), a rare, inherited disorder that causes progressive neurological decline. The therapy uses a harmless virus to deliver a functional copy of the gene encoding iduronate‑2‑sulfatase (I2S) directly into the central nervous system. By restoring the missing enzyme, RGX‑121 aims to slow or even reverse the harmful buildup of substances in the brain that drive the disease’s progression.Another promising candidate is Ultragenyx Pharmaceuticals’ one-time intravenous gene therapy UX111 for Sanfilippo syndrome type A (MPS 3A). This devastating disorder, which leads to severe neurodegeneration in children, currently has no effective treatment. UX111 uses an adeno‑associated virus (AAV) to deliver a working copy of the SGSH gene, the deficiency of which is responsible for the disease. By enabling the body to produce the missing enzyme, UX111 holds the promise of slowing or even halting the progression of neurodegeneration.Our viewThis year has already seen several first-in-class approvals, such as Vertex’s suzetrigine (Journavx), a pioneering non‐opioid analgesic redefining pain management; SpringWorks’ mirdametinib (Gomekli), a breakthrough MEK inhibitor for a genetic disorder that often leads to the growth of benign tumors along nerves and; AstraZeneca and Daiichi’s ADC datopotamab deruxtecan (Datroway).Despite the volatile political environment in the US and its impact on federal agencies like the FDA, we are hopeful that many of the first-in-class drugs mentioned in this article will make a debut in 2025.

Impressions: 3527

NEWS #PharmaBuzz

Noven Debuts ADHD Mindful Patch Companion App at APSARD 2025

14 Jan 2025

// BUSINESSWIRE

Hisamitsu launches Salonpas Diclofenac Patch 1% for pain relief

03 Nov 2023

// BIOSPECTRUM ASIA

Hisamitsu Ordered to Suspend Biz over Salonpas OTC Data Tampering

13 Aug 2021

// JIHO

SECUADO® (asenapine) Transdermal System, the First-and-Only Transdermal Patch

13 Apr 2020

// BUSINESSWIRE

FDA Approves Noven Pharmaceuticals’ Transdermal Patch for Schizophrenia

15 Oct 2019

// BIOSPACE

Noven Pharma, Hisamitsu Pharma sue Mylan on generic Minivelle

06 May 2015

// Potters Bar PHARMA BIZ

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