HSINCHU, Dec. 2, 2025 /PRNewswire/ -- Amaran Biotech, a next-generation Contract Development and Manufacturing Organization (CDMO), announced that its self-developed, GMP-grade high-purity vaccine adjuvant AB-801 has received an Acknowledgement Letter from the U.S. Food and Drug Administration (FDA) for its Type II Drug Master File (DMF). Amaran Biotech is now the first adjuvant supplier in Taiwan to obtain FDA DMF Acknowledgement. This milestone underscores the company's strong capabilities in adjuvant process development, quality management, and international regulatory compliance, while further enabling global vaccine development collaborations.
Vaccine adjuvants are essential components that enhance immune responses, improve vaccine efficacy, and reduce the required antigen dosage. AB-801 offers application characteristics comparable to the widely used QS-21 adjuvant and is derived from the Quillaja saponaria tree native to Chile, Bolivia, and Peru. The DMF provides comprehensive documentation on the manufacturing processes and quality controls of drug substances. Through this filing, Amaran Biotech can provide global partners with complete specifications, process information, and analytical methods for use in vaccine-related regulatory filings, facilitating smoother submissions and development progress.
Dr. Tessie Che, Chairperson and General Manager of Amaran Biotech, stated: "The FDA DMF filing of AB-801 is a significant validation of our team's technical expertise and robust quality systems. We will continue expanding our technological capabilities and manufacturing capacity to help global partners accelerate vaccine development."
Amaran Biotech provides integrated solutions including vaccine adjuvants, drug substance manufacturing, aseptic fill–finish, analytical sciences, and stability testing services. The DMF filing of AB-801 will further strengthen the company's global collaborations and international business development.
Amaran Biotech has also been invited by the Hsinchu Science Park to participate in the 2025 Healthcare+ EXPO Taiwan from December 4–7, 2025. The company will exhibit at the Science Park Pavilion on the 4th floor of Hall 1 at the Taipei Nangang Exhibition Center (Booth N613a) and warmly welcomes industry partners to visit and connect with the team.
About Amaran Biotech
Amaran Biotech is a CDMO (Contract Development & Manufacturing Organization) specializing in drug process development, analytical services and cGMP manufacturing of high-value biopharmaceuticals. Amaran Biotech's state-of-the-art manufacturing facility is in the Hsinchu Biomedical Science Park and has been granted the PIC/S GMP certification from the TFDA since 2017. The company has also been audited and fully qualified by the regulatory agencies and third-party auditors from the USA and the EU. In 2022, Amaran Biotech introduced Taiwan's first fully automated robotic aseptic filling line. In 2025, Amaran Biotech was honored with the "Bioprocessing Excellence in Taiwan" award at the Asia-Pacific Biopharma Excellence Awards, the "Best Fill-Finish" award at the Asia-Pacific Biologics CDMO Excellence Awards in Singapore, and the "Best CDMO in Automated Aseptic Filling" award at the Taiwan Biopharma Excellence Awards, all presented by IMAPAC. Dr. Tessie Che, Chairperson and General Manager of Amaran Biotech, has extensive experience in the global pharmaceutical and biotech industries and successfully led the register and commercialize the antibiotic drug DIFICID® (Fidaxomicin) in the U.S., Canada, and Europe. For more information, visit www.amaranbiotech.com
source: Amaran Biotechnology, Inc.
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