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    Company profile for IWAKI SEIYAKU

    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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    Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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    Fishfa Biogenics: Renowned Manufacturer, & Exporter of Tacrolimus & Mupirocin API.

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    pharmacompass-2-m-2025-11-03

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    EVENTS

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    About

    With “Health for Humanity” and “Infinite Possibilities of the Development of Chemical Science and Technology” as our visions, Iwaki Seiyaku Company Ltd. has been always striving to meet the needs of the new era. Our goal is to contribute to our society through innovation and diligent progress. Formulations Active Pharmaceutical Ingredients Specialty Chemicals 　This triangular foundation supports the robustnes...
    With “Health for Humanity” and “Infinite Possibilities of the Development of Chemical Science and Technology” as our visions, Iwaki Seiyaku Company Ltd. has been always striving to meet the needs of the new era. Our goal is to contribute to our society through innovation and diligent progress. Formulations Active Pharmaceutical Ingredients Specialty Chemicals 　This triangular foundation supports the robustness of our business.

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    CONTACT DETAILS

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    IWAKI SEIYAKUjapan Flag
    Country
    Country
    Japan
    Address
    Address
    8-2, Nihonbashi Honcho 4-Chome, Chuo-ku, Tokyo 103-8434, Japan
    Telephone
    Telephone
    81-3-3668-1571
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.iwakiseiyaku.co.jp/en/
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Over 500 million syringes of our hyaluronic acid have been safely used worldwide”

    mic“Over 500 million syringes of our hyaluronic acid have been safely used worldwide”

    This week, SpeakPharma interviews Marie-Armelle Floc’h, Chief of Quality and Regulatory Affairs at HTL Biotechnology, a global leader in the development and the manufacturing of pharmaceutical-grade biopolymers headquartered in Javené, Brittany (France). Since 1992, HTL has pioneered the production of hyaluronic acid (HA) through proprietary biofermentation, achieving unmatched purity and consistency for applications in ophthalmology, dermatology and rheumatology. Floc’h highlights how HTL Biotechnology’s compelling portfolio of pharmaceutical-grade biopolymers is built on uncompromising quality standards. These standards have enabled the company to supply biopolymers for over 30 years without a single batch recall, firmly establishing its reputation for reliability and excellence. She also discusses the inauguration of HTL Biotechnology’s new sterile hyaluronic acid production unit — a major milestone that reinforces the company’s leadership in biopolymer manufacturing and enables the development of innovative formulations combining hyaluronic acid with thermo-sensitive active ingredients. This new capability opens the door to advanced biomedical applications where safety, stability and efficacy must be preserved without compromising the integrity of delicate molecules and which requires the highest quality standards. What distinguishes HTL Biotechnology’s biopolymer platforms in the market today? HTL Biotechnology has built its reputation on delivering pharmaceutical‑grade biopolymers (hyaluronic acid, polynucleotides and recombinant collagen) with unmatched purity and consistency. Since its founding in 1992, the company has focused on premium quality positioning. With more than 30 years of experience, HTL Biotechnology guarantees pharmaceutical-grade biopolymers of exceptional purity and exemplary consistency to our clients. We have had no batch recalls in 30 years, a record that underlines the rigor and reliability embedded in our processes. This was made possible by our fully-integrated site in France, where R&D laboratories, GMP manufacturing, quality control, and regulatory expertise are brought together under one roof. Such integration allows us to support our clients seamlessly throughout their product development journey, from early innovation through to global commercialization.Also, the inauguration of our new sterile hyaluronic acid production unit expands the possibilities for our HA to be used in advanced formulations with thermo-sensitive active ingredients, while upholding the uncompromising quality that defines HTL Biotechnology.Our operations are guided by internationally recognized standards, including ISO 13485 certification, which ensures the quality and safety required by medical device manufacturers worldwide.In addition, our Halal certification provides our customers with a significant advantage in accessing and expanding into markets where these requirements are essential for commercialization.Beyond certifications, our commitment to supporting global growth is reflected in the Drug Master Files we maintain across five continents, enabling our clients to accelerate product registration and bring innovative therapies to markets across the world more efficiently. By combining craftsmanship with pharmaceutical rigor, supported by state-of-the-art equipment and advanced bio-production methods, we ensure that every batch produced not only meets the strictest standards, but also delivers the reliability and consistency needed across the entire healthcare ecosystem. HIGHLIGHTS// Biopolymers with unmatched purity/record of no batch recalls/integrated facility in France/operations guided by global standards/new sterile HA unit for advanced formulations  Navigating the complex and evolving regulatory frameworks across global markets can be challenging for healthcare companies. Can you tell us more about how HTL Biotechnology supports its partners in this area? Regulatory support is part of our core premium services offer. We provide pharmaceutical regulatory support to ensure products meet the necessary compliance standards, so our partners can focus on their growth. Our dedicated regulatory professionals bring global and regional expertise, with a team specifically supporting customers in Asia. We offer personalized assistance adapted to their products and to the compliance standards of the target market. This includes personalized case-management support for regulatory file submissions with the concerned health authorities to minimize risks of refusal or delay, with the aim of achieving approval quickly and smoothly.Our offer for regulatory support continues beyond approval. We continuously monitor updates to regulations and provide post-commercialization support to our partners to help them manage any necessary regulatory updates.HIGHLIGHTS// Regulatory support offered as premium service/global and regional expertise/personalized case management for faster approvals/continuous regulatory support  How does HTL Biotechnology integrate sustainability and corporate responsibility into its operations? Sustainability is embedded in HTL Biotechnology’s strategic vision and day-to-day operations. In 2024, the company renewed its commitment to environmental responsibility by reinforcing its corporate social responsibility (CSR) roadmap. Tangible progress was made across multiple fronts: a 27 percent reduction in greenhouse gas emissions per kilogram of HA produced between 2021 and 2024, and a 34 percent reduction in water consumption per kilogram of HA since 2020. In 2024, we renewed the ISO 14001:2015 certification for its environmental management system, reflecting rigorous audit protocols and continual improvement cycles. All employees have been trained in the ISO 14001-certified environmental management system, and 78 percent of critical suppliers have signed HTL Biotechnology’s Responsible Purchasing Charter.These results reflect HTL Biotechnology’s structured and proactive approach to reducing its environmental footprint while maintaining the highest standards of quality and compliance.HIGHLIGHTS// Sustainability embedded in strategic vision/strong CSR roadmap with measurable progress/reduction in greenhouse gas emissions/responsible sourcing 

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    https://www.pharmacompass.com/speak-pharma/over-500-million-syringes-of-our-hyaluronic-acid-have-been-safely-used-worldwide

    PharmaCompass
    04 Nov 2025
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    VLOG #PharmaReel

    [Sponsored by another company]

    ReelPharmaYour API, Our ExpertiseYour API, Our Expertise

    Your API, Our Expertise
    Your API, Our Expertise

    reelYour API, Our Expertise

    This PharmaReel showcases Minakem as a trusted partner for APIs, HPAPIs and steroids from FDA/GMP-certified sites, offering generic & custom solutions and CDMO services from lab to commercial supply, backed by regulatory know-how.

    Impressions: 198

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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    Excipient Market Overview: Evonik launches high-purity excipients; India mandates disclosures from March 2026

    Excipient Market Overview: Evonik launches high-purity excipients; India mandates disclosures from March 2026

    The global pharmaceutical excipients market continued to evolve in the third quarter (Q3) of 2025, supported by rising demand for functional excipients, growth in production of generics, and advances in drug delivery technologies. The global market for pharmaceutical excipients was estimated at US$ 9.8 billion to US$ 10.7 billion in 2024, and is projected to grow at a compound annual growth rate (CAGR) of 4.1 to 6.6 percent through 2030. At this pace, the market is expected to reach US$ 13.05 billion to US$ 14.86 billion by 2030. Europe retained the largest market share in 2024, followed by Asia-Pacific. Key drivers shaping the excipients market include the rising prevalence of chronic diseases, expansion of biologics and biosimilars, and increasing quality and regulatory expectations. Increased investments in facility expansions and ongoing reforms in clinical trial regulations are also facilitating market growth. The sector remains highly competitive and fragmented. Major excipient providers include BASF, Roquette, Gangwal Healthcare, DuPont, Evonik, Seqens, SPI Pharma, PMC Isochem, Croda International, Pfanstiehl, Colorcon, Kewpie Corporation, ICE Pharma, Nanjing Well Pharmaceutical, Merck KGaA owned MilliporeSigma, Minakem, Ashland Global, Actylis and Nippon Fine Chemical.  View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)  Evonik in partnership with Ethris; Colorcon Ventures invests in Phytolon   The market saw strategic collaborations across the excipients and drug formulation ecosystem in Q3 2025. Evonik entered into a partnership with Ethris to strengthen its nucleic acid delivery platform. The collaboration integrates Ethris’ proprietary technology — its lipidoid nanoparticle platform, known as SNaP LNP — into Evonik’s CDMO offerings, enhancing the latter’s ability to support RNA-based therapeutics from concept to clinic. Colorcon Ventures, the investment arm of Colorcon, announced a strategic investment in Israel-based Phytolon. The biotechnology start-up uses precision fermentation to develop natural colorants. The investment underscores Colorcon’s commitment to next-generation coloring technologies that support cleaner-label formulations and innovation in oral solid dosage coatings.  View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)   Evonik launches MaxiPure Polysorbate 80; Asahi Kasei expands its portfolio The quarter saw continued innovation in high-purity and injectable-grade excipients. Evonik introduced MaxiPure Polysorbate 80, a high-purity injectable-grade surfactant designed for biologics and parenteral formulations. This excipient addresses key challenges such as protein stability, viral inactivation, and the solubilization of hydrophobic APIs, while meeting regulatory expectations across global markets. Asahi Kasei expanded its Sonanos portfolio of excipients with two new products — Sonanos PG (optimized for sustained release of biologics and peptides while supporting patient-friendly dosing)  and Sonanos DS (developed to enhance solubility of poorly water-soluble APIs). These additions reflect growing industry demand for dosage optimization, stability, and specialized delivery of complex molecules. Gangwal Healthcare operates EXCiPACT-certified GMP facilities and offers a broad range of functional excipients, including co-processed blends like ProBlend, Starlose, and Microlose. Its excipients, including Solvostar (sodium starch glycolate) and Sallyso (croscarmellose sodium), support enhanced tablet disintegration and drug release. The company also provides taste-masking agents such as SucreX (sucralose) and CutCal (neotame), supporting the development of patient-friendly oral dosage forms.  View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)   Colorcon, Gattefossé, Croda, Roquette, Clariant expand manufacturing capacities Manufacturing investments and facility expansions remained a key trend during Q3 2025. Colorcon inaugurated a new state-of-the-art, film coating manufacturing facility in Johor, Malaysia. The site incorporates energy-efficient systems and advanced production technologies to strengthen Colorcon’s functional-excipient supply network across Asia. Gattefossé opened a new lipid-based excipient facility in Texas (US), marking a strategic expansion of its North American manufacturing footprint. Croda International expanded its Leek, UK facility with a lipid system synthesis unit and enhanced R&D capabilities. The site will support the launch of Super Refined Poloxamer 188, a highly purified fast-dissolving granular excipient. Roquette announced the opening of a dedicated innovation center in São Paulo, Brazil, strengthening its engagement with regional drug developers. Clariant expanded its Daya Bay, China facility, adding a second spray tower dedicated to pharmaceutical excipient production. The upgraded site increases capacity for excipients used in laxatives and other formulations. BASF also strengthened its commitment to biopharma and pharmaceutical ingredients with a new GMP Solution Center in Michigan (US). The facility expands BASF’s network of poloxamer (a synthetic polymer) manufacturing sites. With state-of-the-art clean room packaging and high-sensitivity analytical testing, this new facility will enable close collaboration with BASF’s customers on customized chemistries for product development.  View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)   India mandates excipient disclosure; new rules to apply from March 2026  India has made it mandatory to disclose excipient details from March 2026 under the country’s new Drugs (2nd Amendment) Rules, 2025. This applies to Schedule H2 medicines. The final notification expands earlier draft requirements by mandating qualitative excipient details in QR codes on product packaging. This should enhance transparency and support patient safety. Meanwhile, US pharmaceutical groups have responded to the US Food and Drug Administration’s draft guidance proposing simplified pathways for replacing color additives in drug products. Industry associations have supported draft guidance, noting that it reduces regulatory burden while maintaining product quality and consistency.  View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)   Our view While the fast-growing generics market is creating demand for cost-effective and versatile excipients, the market is also witnessing innovations tailored to the specialized needs of biologics and biosimilars. India is poised to become a key player in the global excipient market, supported by the rapid growth in its generic drug industry, expansion of its health infrastructure and increasing investments in R&D. The new excipient-disclosure rules, therefore, are likely to benefit the global excipient industry by improving transparency and strengthening quality ecosystems.
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    Impressions: 316

    https://www.pharmacompass.com/radio-compass-blog/excipient-market-overview-evonik-launches-high-purity-excipients-india-mandates-disclosures-from-march-2026

    #PharmaFlow by PHARMACOMPASS
    20 Nov 2025
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    ALL APIs

    read-moreClick the button for full data set
    read-moreClick the button for full data set

    01

    Phenylephrine Hydrochloride

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BOS Manchester
    Not Confirmed
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    Phenylephrine Hydrochloride

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BOS Manchester
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-06-24

    Pay. Date : 2013-06-12

    DMF Number : 8140

    Submission : 1989-07-07

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 217MF10030

    Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo

    Initial Date of Registration : 2005-05-20

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2011-10-28

    Registration Number : 20071228-88-D-12-04(2)

    Manufacturer Name : Iwaki Seiyaku Co., Ltd.

    Manufacturer Address : 1700, hamagawa shinden, kakegawa-city, shizuoka-pref(F4)

     VMF Others AUDIT
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    02

    Pilocarpine Hydrochloride

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BOS Manchester
    Not Confirmed
    arrow

    Pilocarpine Hydrochloride

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BOS Manchester
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-06-16

    Pay. Date : 2017-05-17

    DMF Number : 12388

    Submission : 1997-02-21

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 217MF10035

    Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo

    Initial Date of Registration : 2005-05-20

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    03

    Cetirizine Dihydrochloride

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BOS Manchester
    Not Confirmed
    arrow

    Cetirizine Dihydrochloride

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BOS Manchester
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21864

    Submission : 2008-08-05

    Status : Inactive

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 218MF10273

    Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo

    Initial Date of Registration : 2006-02-23

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    04

    Betahistine Dimesilate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BOS Manchester
    Not Confirmed
    arrow

    Betahistine Dimesilate

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BOS Manchester
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS JDMF arrow-down
    ✖

    Registration Number : 217MF10043

    Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo

    Initial Date of Registration : 2005-05-20

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    05

    Calcium Glycerophosphate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BOS Manchester
    Not Confirmed
    arrow

    Calcium Glycerophosphate

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BOS Manchester
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS JDMF arrow-down
    ✖

    Registration Number : 217MF10051

    Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo

    Initial Date of Registration : 2005-05-20

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    06

    Metoprolol Tartrate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BOS Manchester
    Not Confirmed
    arrow

    Metoprolol Tartrate

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BOS Manchester
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS JDMF arrow-down
    ✖

    Registration Number : 217MF10047

    Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo

    Initial Date of Registration : 2005-05-20

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    07

    Mexiletine

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BOS Manchester
    Not Confirmed
    arrow

    Mexiletine

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BOS Manchester
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF CEP/COS JDMF arrow-down
    ✖

    Registration Number : 217MF10039

    Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo

    Initial Date of Registration : 2005-05-20

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    08

    Sertraline Hydrochloride

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BOS Manchester
    Not Confirmed
    arrow

    Sertraline Hydrochloride

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BOS Manchester
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF CEP/COS JDMF arrow-down
    ✖

    Registration Number : 226MF10149

    Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo

    Initial Date of Registration : 2014-09-01

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    09

    Sodium Picosulfate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BOS Manchester
    Not Confirmed
    arrow

    Sodium Picosulfate

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BOS Manchester
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF CEP/COS JDMF arrow-down
    ✖

    Registration Number : 217MF10037

    Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo

    Initial Date of Registration : 2005-05-20

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    10

    Trichlormethiazide

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BOS Manchester
    Not Confirmed
    arrow

    Trichlormethiazide

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BOS Manchester
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF CEP/COS JDMF arrow-down
    ✖

    Registration Number : 217MF10042

    Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo

    Initial Date of Registration : 2005-05-20

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    IWAKI SEIYAKU is a supplier offers 34 products (APIs, Excipients or Intermediates).

    Find a price of Phenylephrine Hydrochloride bulk with DMF, JDMF offered by IWAKI SEIYAKU

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