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    Company profile for Chunghwa Chemical Synthesis & Biotech

    Chunghwa Chemical Synthesis & Biotech-PSE
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    2025 Corporate Sustainability Report Award

    12 Nov 2025

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    The company accomplished Ethyl Icosapentate, Everolimus audit

    09 Sep 2025

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    The company accomplished Everolimus audit

    04 Sep 2025

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

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    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.

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    Chunghwa Chemical Synthesis & BiotechTaiwan Flag
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    Taiwan
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    1 Tung-Hsing St., Shu-Lin Dist., 23850, New Taipei City
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    +886 286843318
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    tina.yang@ccsb.com.tw
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    http://www.ccsb.com.tw/
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    https://www.linkedin.com/company/chunghwa-chemical-synthesis-&-biotech-co.-ltd./
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    Product List 2024

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    GMP Certificate 2024

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    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.
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    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

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    09 Apr 2026
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    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
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    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
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    The company accomplished Everolimus audit
    The company accomplished Everolimus audit

    04 Sep 2025

    // PRESS RELEASE

    http://www.ccsb.com.tw/english/04_news/02_detail.aspx?pid=1&xid=135

    PRESS RELEASE
    04 Sep 2025
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    The company accomplished Tacrolimus audit, a client from India
    The company accomplished Tacrolimus audit, a client from India

    29 May 2025

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    http://www.ccsb.com.tw/english/04_news/02_detail.aspx?pid=1&xid=132

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    29 May 2025
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    Audit Completed for Caspofungin and Trandolapril Client
    Audit Completed for Caspofungin and Trandolapril Client

    14 May 2025

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    http://www.ccsb.com.tw/english/04_news/02_detail.aspx?pid=1&xid=131

    PRESS RELEASE
    14 May 2025
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    The company accomplished Rapamycin audit, a client from Japan
    The company accomplished Rapamycin audit, a client from Japan

    16 Apr 2025

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    http://www.ccsb.com.tw/english/04_news/02_detail.aspx?pid=1&xid=130

    PRESS RELEASE
    16 Apr 2025
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    Chunghwa Chemical Synthesis & Biotech is a supplier offers 45 products (APIs, Excipients or Intermediates).

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