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INTERVIEW #SpeakPharma
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ACTIVE PHARMA INGREDIENTS

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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

CPhI India 2024CPhI India 2024

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26-28 November, 2024

India Expo Centre, Greater Noida
Saudi International Ex...Saudi International Expo

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28-30 October, 2024

Riyadh International Convention Center
SupplySide West 2024SupplySide West 2024

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28 October-01 November, 2024

Mandalay Bay, Las Vegas, NV

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CONTACT DETAILS

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Japan

Address

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

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+81-(0)3-5293-1720

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

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INTERVIEW #SpeakPharma

[Sponsored by another company]

“Due to its 20-year mastery in micronization, Inke has emerged a cornerstone in treating global respiratory diseases”

This week, SpeakPharma interviews Miquel Bachs, CEO of Inke, a company with over two decades of expertise in micronization and particle engineering, and a leader in providing high-quality, effective solutions in the global fight against chronic respiratory diseases such as COPD and asthma. In this insightful conversation, Bachs shares Inke’s strategic vision, technological innovations, and commitment to sustainability, offering a comprehensive look at how the company is shaping the future of respiratory health. HIGHLIGHTS// Inke’s strategic vision/ technological innovations/ commitment to sustainability Studies suggest that 13 percent of people over 40 years of age, the world over, have chronic obstructive pulmonary disease (COPD). Given the increasing prevalence of respiratory diseases, how does Inke position itself as a leader in the development and manufacturing of respiratory APIs? Inke has established itself as a global leader in generic respiratory API development through our unique blend of technological innovation, expertise in micronization, and a comprehensive portfolio of inhalation therapies. With over 20 years of experience in micronization and particle engineering, our ability to customize APIs to meet specific client requirements has resulted in highly effective, high-quality products tailored for respiratory therapies. The increasing prevalence of chronic respiratory diseases, such as COPD and asthma, has only underscored Inke’s pivotal role in supporting the pharmaceutical industry’s need for advanced treatments. We specialize in bronchodilators and other critical respiratory APIs that improve patient outcomes and meet the stringent regulatory requirements of global health authorities. Our end-to-end approach, from early-stage API development to commercial-scale production, ensures that we maintain the highest standards of quality, safety, and efficacy. As the market for respiratory APIs continues to evolve, Inke remains committed to expanding its portfolio to address unmet therapeutic needs. Beyond respiratory APIs, we are also prioritizing growth in CNS treatments and building on our expertise in complex molecule synthesis. This strategic focus allows us to provide an integrated solution that not only meets current market demands but also anticipates future pharmaceutical trends. HIGHLIGHTS// comprehensive portfolio of inhalation therapies/ over 20 years of experience in micronization and particle engineering/ specialize in bronchodilators and other critical respiratory APIs/ prioritizing growth in CNS treatments In the field of micronization, what differentiates Inke’s approach from that of other manufacturers of respiratory APIs? What sets Inke apart in micronization is our advanced particle size reduction technology and our dedication to precision. Our facility is equipped with various milling techniques such as Cone, Jet, and Pin mills, allowing us to reduce particle size while stabilizing the amorphous content to ensure consistent quality. Our in-depth understanding of respiratory APIs, combined with our ability to tailor solutions for each customer, results in APIs with improved solubility, stability, and bioavailability, which are critical for the efficacy of inhalation products. This, along with our exceptional quality standards and a flawless audit track record, has positioned us as a key partner for major players in the inhalation market. HIGHLIGHTS// advanced particle size reduction technology/ technological innovations/ tailor solutions/ improved solubility, stability, and bioavailability Developing complex APIs can be challenging. How does Inke ensure a smooth and successful partnership throughout the development and manufacturing process, including customization, ensuring regulatory compliance and timely delivery? At Inke, we are dedicated to fostering strong partnerships with our clients through a collaborative approach that prioritizes open communication and mutual understanding. Our commitment to quality and personalized service sets us apart in the pharmaceutical landscape. Our team takes the time to engage in comprehensive discussions to customize our solutions, ensuring alignment with client specifications across all batches and grades. This commitment to flexibility allows us to respond effectively to evolving requirements, solidifying Inke’s reputation as a reliable partner. We understand that navigating regulatory landscapes can be challenging. That's why our team is equipped to manage all aspects of the regulatory process with meticulous attention to detail. From the submission of Drug Master Files (DMFs) and Certificates of Suitability to crafting precise responses to potential Deficiency Letters, we ensure compliance at every step. Moreover, we offer extensive support in patent and intellectual property matters, providing technical assistance and guidance tailored to the specific requirements of each region. Our unwavering dedication to quality, coupled with our agile response capabilities, enables us to deliver exceptional results while maintaining transparency and trust. At Inke, we are committed to building lasting relationships that drive success for both our clients and our organization. HIGHLIGHTS// ensuring alignment with client specifications/ manage all aspects of the regulatory process/ support in patent and intellectual property matters Given Inke’s global presence, what are the key markets for growth and how does Inke plan to expand its market reach and strengthen its position in these regions? Inke is strategically focused on expanding its footprint in the European and US markets, where we continue to prioritize our efforts. The US market remains pivotal for us, especially considering our successful FDA inspections and ongoing regulatory compliance efforts that solidify our reputation. Japan is another significant market where we have established a robust presence, reflecting our commitment to high-quality manufacturing and innovation. Looking ahead, China represents a key growth opportunity for Inke. With 12 active DMFs registered, we are well-positioned to tap into this burgeoning market. Our strategy involves leveraging our existing capabilities to navigate regulatory landscapes and fostering strong partnerships within the region, thereby enhancing our market reach and influence in the pharmaceutical sector. HIGHLIGHTS// expanding footprint in the European and US markets/ China represents a key growth opportunity for Inke With Inke expanding into contract manufacturing organization (CMO) services, how does this new offering align with Inke’s broader strategic goals, and what advantages does it provide to pharmaceutical partners? At Inke, the introduction of CMO services is a natural extension of our core expertise in the development and manufacturing of high-quality generic APIs. Our expansion into CMO is part of a strategic move to diversify our service portfolio, allowing us to offer end-to-end solutions for our clients. The CMO service integrates seamlessly with our expertise in API manufacturing, particularly in micronization, which has been a key differentiator for Inke for over two decades. With our advanced particle engineering capabilities, we can offer tailored solutions that meet specific technical and regulatory requirements. Whether it is small-batch production or scaling up to commercial quantities, we offer the flexibility to accommodate a wide range of customer needs. This adaptability, paired with our deep expertise in micronization, allows us to support evolving project needs, maintaining the highest standards of consistency, quality, and performance that define Inke’s footprint. HIGHLIGHTS// CMO is part of a strategic move to diversify our service portfolio/ deep expertise in micronization What is Inke’s commitment to sustainability and corporate social responsibility and how is it integrating sustainable practices into its operations and product development? At Inke, we recognize that integrating environmental, social, and governance (ESG) principles into our operations is not just a responsibility but a pathway to long-term success. Our ESG vision is centered around aligning business growth with sustainable practices that positively impact our communities and the environment. We are dedicated to environmental responsibility, actively implementing initiatives such as efficient wastewater treatment and water reuse systems to minimize our ecological footprint. Our recent investments in energy efficiency include the installation of a 135 kWp solar panel system, which underscores our commitment to reducing emissions and resource consumption across our manufacturing and research facilities. Inke is also committed to fostering a diverse and inclusive workforce. With a notable increase in our team members, particularly in operations and quality assurance, we prioritize career development and the well-being of our employees. By adhering to high regulatory standards, we ensure our products meet stringent global requirements, enhancing our transparency and compliance. Through these initiatives, Inke aims to cultivate sustainable practices that not only support our business objectives but also contribute positively to the pharmaceutical industry and society at large. HIGHLIGHTS// integrating ESG principles/ efficient wastewater treatment and water reuse systems/ installation of a 135 kWp solar panel system/ diverse and inclusive workforce

Impressions: 441

VLOG #PharmaReel

[Sponsored by another company]

Full-Service Generic API Company

DATA COMPILATION #PharmaFlow

[Sponsored by another company]

DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024. Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each. The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders). View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453 US$ 3,21,920 Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427 US$ 2,31,952 FDF—Foreign US$ 2,35,427 US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629 US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852 US$ 7,56,666 Small business generic drug applicant US$ 1,72,963 US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.

Impressions: 2508

NEWS #PharmaBuzz

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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