menu
    • menu

    Company profile for Chunghwa Chemical Synthesis & Biotech

    Chunghwa Chemical Synthesis & Biotech-PSE
    News
    Cenra API and BioDuro Form JV to Boost API Manufacturing

    03 Mar 2026

    // PRESS RELEASE

    CCSB Gets US Patent for Selumetinib Sulfate Crystal Forms

    24 Feb 2026

    // PRESS RELEASE

    CCSB/CAS obtained US patent: Preparation Method of Setmelanotide

    30 Jan 2026

    // PRESS RELEASE

    DATA COMPILATION
    #PharmaFlow

    CCSB VB RM

    Contact Supplier

    Website

    CPhI China

    Exhibiting

    Book a meeting

    envelop Contact Supplier

    Latest Content by PharmaCompass

    https://www.youtube.com/embed/0VmDGdKgI9U

    EVENTS

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    Key Products KEY PRODUCTS

    SERVICES

    Key Products KEY SERVICES

    INSPECTIONS & REGISTRATIONS

    PharmaCompass

    Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

    Related CompaniesRelated Companies

    About

    Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers cost-effective APIs with speed, supported by a skilled team. As the first Southeast Asian company to receive FDA approval for synthetic and biotech APIs, CCSB has commercialized Statin, Immunosuppressant, Muscle Relaxant, and ACE Inhibitor APIs with complete DMF or COS. It partners with leading drug companies to develop and produce specialty APIs using advanced fermentation and synthesis technologies in Taiwan. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    CONTACT DETAILS

    Click the arrow to open the dropdown
    Contact SupplierContact
    Google MapGoogle Map
    Full View ScreenFull View Screen
    Chunghwa Chemical Synthesis & BiotechTaiwan Flag
    Country
    Country
    Taiwan
    Address
    Address
    1 Tung-Hsing St., Shu-Lin Dist., 23850, New Taipei City
    Telephone
    Telephone
    +886 286843318
    Client Email
    Email
    tina.yang@ccsb.com.tw
    Client Website
    Website
    http://www.ccsb.com.tw/
    Linkedin
    Linkedin
    https://www.linkedin.com/company/chunghwa-chemical-synthesis-&-biotech-co.-ltd./
    youtube
    YouTube
    Twitter
    Twitter
    Contact Info
    Others

    Events

    Webinars & Exhibitions

    Request a meetingRequest a meeting
    Full Screen ViewFull Screen View
    Default Event

    CPhI China

    Exhibiting

    envelop Contact Supplier

    CPhI China

    Contact Supplier

    Meeting

    Digital content read-more

    Explore the latest content creation from this company

    CORPORATE CONTENT #SupplierSpotlight

    Product List 2024

    read-more

      https://www.pharmacompass.com/pdf/party/content/chunghwa-chemical-synthesis-biotech-party-content-3002.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    Corporate Presentation

    read-more

      https://www.pharmacompass.com/pdf/party/content/chunghwa-chemical-synthesis-biotech-party-content-10307.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    CMO/CDMO Services

    read-more

      https://www.pharmacompass.com/pdf/party/content/chunghwa-chemical-synthesis-biotech-party-content-84116.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    GMP Certificate 2024

    read-more

      https://www.pharmacompass.com/pdf/party/content/chunghwa-chemical-synthesis-biotech-party-content-40024.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    DATA COMPILATION #PharmaFlow

    read-more
    read-more
    CEP Q1 2026 Update: CEP 2.0, EDQM’s new guidelines strengthen ecosystem; Indian firms top list of CEPs issued

    CEP Q1 2026 Update: CEP 2.0, EDQM’s new guidelines strengthen ecosystem; Indian firms top list of CEPs issued

    PharmaCompass is introducing a new regulatory update that tracks developments in Certificates of Suitability to the Monographs of the European Pharmacopoeia, referred to as CEPs. These certificates are a critical regulatory instrument in the global pharmaceutical supply chain.Also known as a Certification of Suitability (COS), CEPs are issued by the European Directorate for the Quality of Medicines and HealthCare (EDQM), with or without inspection of the manufacturing site. A CEP must be renewed every five years from its original issue date to remain valid, regardless of any revisions made during the interim period. However, a CEP does not replace Good Manufacturing Practice certification.CEPs are recognized as a trusted reference for API quality, thereby simplifying global registration strategies. Apart from Europe, the CEP system is widely used by many regulatory authorities, including those in Canada, Australia, Brazil, Singapore and South Africa. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)CEP 2.0 enhances regulatory clarity, brings efficiency, global interoperability There are several types of CEPs, depending on the nature of the substance and evaluation. The most common type is the Chemical CEP, which confirms that a chemically synthesized API meets standards for purity and impurity control. Then there are Herbal CEPs for herbal substances and preparations.Another key category is the TSE CEP, which addresses risks associated with transmissible spongiform encephalopathies in animal-derived materials. In addition, there are Combined CEPs that may cover multiple aspects, such as chemical quality, TSE risk, and sterility. However, biological products such as vaccines and blood products fall outside the scope of the CEP framework.In 2023, the CEP system underwent a major transformation with the introduction of CEP 2.0, which marks a shift from a largely document-based system to a more structured, transparent, and digitally aligned model. This makes it easier for companies to manage compliance while improving trust among global regulators.While increasing data and compliance requirements for API manufacturers, CEP 2.0 enables better regulatory clarity, streamlined dossier integration, and stronger global acceptance. Overall, CEP 2.0 is designed to enhance regulatory clarity while making the system more efficient and globally interoperable. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)Indian firms issued maximum CEPs; Sun Pharma and its subsidiaries, Jubilant Biosys top listIndia topped the charts for CEPs issued, both in terms of new CEPs and revisions in the first quarter (Q1) of 2026. Indian companies were issued 81 new CEPs in Q1 2026 (as against 40 in Q1 2025) and 203 revisions (as against 129 in Q1 2025). In comparison, Chinese companies were issued 42 new CEPs in Q1 2026 (against 25 in Q1 2025) and 53 revisions (against 67 in Q1 2025). Italy came a distant third, followed by Germany and Spain.India’s Sun Pharmaceuticals and its subsidiaries topped the list of companies with the maximum number of CEPs issued— while no new CEP was issued, 27 CEPs were revised in Q1 2026. At second place was Jubilant Biosys — 21 CEPs were revised in Q1 2026.In terms of products, the maximum CEPs were issued for amlodipine besylate (a calcium channel blocker used for treating hypertension), followed by sitagliptin phosphate (a type 2 diabetes medicine) and pregabalin (a drug used to treat neuropathic pain, fibromyalgia, seizures, and generalized anxiety disorder). Both amlodipine besylate and sitagliptin phosphate had not been issued new CEPs or revisions in Q1 2025. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)EDQM introduces new guidelines to accelerate CEP assessments The EDQM charges fees for various services related to CEPs that depend on the type of request or regulatory activity involved. In general, fees apply to handling CEP applications, revisions or renewals and for offering technical advice (where applicants seek scientific or regulatory guidance).In March 2026, the EDQM introduced two new guidelines aimed at accelerating CEP assessments. The first is a reliance-based assessment pathway, which allows regulators to leverage prior approvals from trusted authorities, such as those in the EU, UK, Australia, Canada, and the WHO pre-qualification program. The second is a fast-track assessment route designed to expedite reviews in situations such as medicine shortages and to support initiatives like the EU Critical Medicines Act.Timelines have been significantly compressed under these new pathways. Initial evaluations are completed within 46 working days, compared to up to 115 days under the standard procedure. Applicants are given 30 calendar days to respond to queries, after which regulators complete the final assessment within 23 working days.Another important regulatory update relates to electronic submissions. From April 1, 2026, the EDQM will reject non-compliant CEP applications at the point of submission. All applications must include a validated electronic Common Technical Document (eCTD) dossier along with a proper validation report, submitted in line with the updated Common European Submission Portal (CESP) guidelines. Taken together, these developments signal a more rigorous yet efficient CEP ecosystem. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)Our viewThe shift to CEP 2.0 signals a move toward greater transparency, digitalization, and global regulatory alignment. Though enhanced disclosure and stricter e-submission requirements may increase the compliance burden, especially for smaller manufacturers, the long-term gains are expected to be significant. Going forward, companies that invest in data quality and regulatory readiness stand to gain from these changes.
    subscribeSubscribe
    ExcelExcel Download

    Impressions: 2601

    https://www.pharmacompass.com/radio-compass-blog/cep-q1-2026-update-cep-2-0-edqm-s-new-guidelines-strengthen-ecosystem-indian-firms-top-list-of-ceps-issued

    #PharmaFlow by PHARMACOMPASS
    09 Apr 2026
    Share Share

    NEWS #PharmaBuzz

    read-more
    read-more
    Cenra API and BioDuro Form JV to Boost API Manufacturing
    Cenra API and BioDuro Form JV to Boost API Manufacturing

    03 Mar 2026

    // PRESS RELEASE

    http://www.ccsb.com.tw/english/04_news/02_detail.aspx?pid=1&xid=141

    PRESS RELEASE
    03 Mar 2026
    Share Share
    CCSB Gets US Patent for Selumetinib Sulfate Crystal Forms
    CCSB Gets US Patent for Selumetinib Sulfate Crystal Forms

    24 Feb 2026

    // PRESS RELEASE

    http://www.ccsb.com.tw/english/04_news/02_detail.aspx?pid=1&xid=140

    PRESS RELEASE
    24 Feb 2026
    Share Share
    CCSB/CAS obtained US patent: Preparation Method of Setmelanotide
    CCSB/CAS obtained US patent: Preparation Method of Setmelanotide

    30 Jan 2026

    // PRESS RELEASE

    http://www.ccsb.com.tw/english/04_news/02_detail.aspx?pid=1&xid=139

    PRESS RELEASE
    30 Jan 2026
    Share Share
    CCSB Gets Taiwan Patent for Selumetinib Sulfate Crystal Forms
    CCSB Gets Taiwan Patent for Selumetinib Sulfate Crystal Forms

    29 Jan 2026

    // PRESS RELEASE

    http://www.ccsb.com.tw/english/04_news/02_detail.aspx?pid=1&xid=138

    PRESS RELEASE
    29 Jan 2026
    Share Share
    2025 Corporate Sustainability Report Award
    2025 Corporate Sustainability Report Award

    12 Nov 2025

    // PRESS RELEASE

    http://www.ccsb.com.tw/english/04_news/02_detail.aspx?pid=1&xid=137

    PRESS RELEASE
    12 Nov 2025
    Share Share
    The company accomplished Ethyl Icosapentate, Everolimus audit
    The company accomplished Ethyl Icosapentate, Everolimus audit

    09 Sep 2025

    // PRESS RELEASE

    http://www.ccsb.com.tw/english/04_news/02_detail.aspx?pid=1&xid=136

    PRESS RELEASE
    09 Sep 2025
    Share Share

    KEY PRODUCTS

    read-more
    read-more

    TOP RANKED SUPPLIER FOR:

    Sponsored Ads.
    full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view

    Services

    Discover the service capabilities from this company

    API Manufacturing

    Discover their expertise for : API Manufacturing

    API & Drug Product Development

    Discover their expertise for : API & Drug Product Development

    KEY SERVICES

    read-more
    read-more

    TOP RANKED SUPPLIER FOR:

    CCSB Popup full-view
    Microbial Fermentation
    full-view

    Inspections and registrations

    Check the inspections & registration from this company
    CCSB Popup

    ABOUT THIS PAGE

    Contact CCSB and get a quotation

    CCSB is a supplier offers 51 products (APIs, Excipients or Intermediates).

    Find Tacrolimus bulk with DMF, CEP, JDMF offered by CCSB

    Find Everolimus bulk with DMF, CEP offered by CCSB

    Find Mycophenolate Sodium bulk with DMF, CEP offered by CCSB

    Find Sirolimus bulk with DMF, JDMF offered by CCSB

    Find Pravastatin bulk with JDMF offered by CCSB

    Find Baricitinib bulk with DMF offered by CCSB

    Find Brivaracetam bulk with DMF offered by CCSB

    Find Caspofungin bulk with DMF offered by CCSB

    Find Dexbrompheniramine Maleate bulk with DMF offered by CCSB

    Find Difelikefalin Acetate bulk with DMF offered by CCSB

    Find Eltrombopag bulk with DMF offered by CCSB

    Find Eslicarbazepine Acetate bulk with DMF offered by CCSB

    Find Everolimus bulk with DMF offered by CCSB

    Find Icosapent Ethyl bulk with DMF offered by CCSB

    Find Methocarbamol bulk with JDMF offered by CCSB

    Find Midostaurin bulk with DMF offered by CCSB

    Find Mycophenolate Mofetil bulk with DMF offered by CCSB

    Find Mycophenolate Mofetil Hydrochloride bulk with DMF offered by CCSB

    Find Ozanimod bulk with DMF offered by CCSB

    Find Palbociclib bulk with DMF offered by CCSB

    Find Plecanatide bulk with DMF offered by CCSB

    Find Ribociclib bulk with DMF offered by CCSB

    Find Selumetinib bulk with DMF offered by CCSB

    Find Setmelanotide Acetate bulk with DMF offered by CCSB

    Find Tacrolimus bulk with DMF offered by CCSB

    Find Tofacitinib Citrate bulk with DMF offered by CCSB

    Find Trandolapril bulk with JDMF offered by CCSB

    Find Trilaciclib Dihydrochloride bulk with DMF offered by CCSB

    Find Abaloparatide bulk offered by CCSB

    Find Carfilzomib bulk offered by CCSB

    Find Dalbavancin bulk offered by CCSB

    Find Edoxaban Tosylate bulk offered by CCSB

    Find Etelcalcetide bulk offered by CCSB

    Find Everolimus bulk offered by CCSB

    Find Favipiravir bulk offered by CCSB

    Find Guaifenesin bulk offered by CCSB

    Find Ixazomib Citrate bulk offered by CCSB

    Find Lanreotide Acetate bulk offered by CCSB

    Find LCZ 696 bulk offered by CCSB

    Find Metaxalone bulk offered by CCSB

    Find Methocarbamol bulk offered by CCSB

    Find Mycophenolic Acid bulk offered by CCSB

    Find Ozanimod bulk offered by CCSB

    Find Perindopril bulk offered by CCSB

    Find Ribociclib bulk offered by CCSB

    Find Ruxolitinib Phosphate bulk offered by CCSB

    Find Sacubitril Sodium bulk offered by CCSB

    Find Semaglutide bulk offered by CCSB

    Find Sugammadex Sodium bulk offered by CCSB

    Find Tenapanor Hydrochloride bulk offered by CCSB

    Find Trilaciclib Dihydrochloride bulk offered by CCSB

    Ask Us for Pharmaceutical Supplier and Partner
    Ask Us, Find A Supplier / Partner
    No Commissions, No Strings Attached, Get Connected for FREE

    What are you looking for?

    How can we help you?

    The request can't be empty

    Please read our Privacy Policy carefully

    You must agree to the privacy policy

    The name can't be empty
    The company can't be empty.
    The email can't be empty Please enter a valid email.
    The mobile can't be empty
    • Privacy policy
    • Terms and conditions
    • Disclaimers
    • LinkedIn
    • Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.

    Market Place

    Market Place

    PharmaCompass

    Home

    Market Place

    Menu

    Post Enquiry

    Post Enquiry

    Market Place

    Market Place

    Search