Mycenax Biotech Inc. (4726) has reached a significant milestone. In February 2025, the company successfully passed an on-site inspection by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). Recently, Mycenax was notified by its client that the product manufactured by Mycenax has officially received PMDA’s manufacturing site transfer approval. This approval represents a major breakthrough for Mycenax’s expansion into the international market, as the company begins commercial production of a biopharmaceutical approved for sale in Japan. A long-term supply agreement has also been signed with the Japanese client, establishing a solid foundation for future revenue growth.
The site inspection was conducted by the PMDA in November 2024 at Mycenax’s Zhunan Facility, the inspection scope included GMP compliance, process validation, and quality management systems. Mycenax received official approval in February, confirming its GMP facility meets Japan’s pharmaceutical regulatory standards. The swift and successful review process highlights Mycenax’s outstanding manufacturing capabilities and high-quality standards, further strengthening its position in the global biopharmaceutical industry.
This project involved a technology transfer from the client to Mycenax. After completing all process validation requirements and consecutive GMP batch productions as required by regulatory authorities, Mycenax successfully obtained official PMDA site transfer approval. This achievement not only deepens Mycenax’s presence in the Japanese CDMO market but also marks an important milestone in the company’s expansion into Japan.
Since its strategic transformation in 2019, Mycenax has built advanced development & production biopharmaceutical technologies and a strict quality management system. Starting in 2024, the company has undergone and passed several on-site inspections by international regulatory authorities, including Japan’s PMDA and the European Medicines Agency (EMA). These achievements confirm that Mycenax’s manufacturing and quality systems are aligned with global standards. Looking ahead, Mycenax will continue to invest in innovation and international expansion, delivering reliable, high-quality solutions to partners around the world. The company will continue to invest in innovation and international growth, delivering reliable, high-quality solutions to partners around the world.
About Mycenax
Mycenax takes the CDMO brand positioning of "big D and medium M" with "Innovative development abilities (D) and Adequate manufacturing capacity (M)" to provides one-stop services for the development and manufacture of traditional biologics and novel biological drugs. At its core, Mycenax is committed to the development and production of biological drugs, from the R&D phase to cGMP manufacturing plants to drug commercialization. Mycenax, as an international CDMO company, continuously invests in product development innovations and technology platform optimizations in order to provide customers with comprehensive and streamlined CDMO services. Mycenax Biotech currently has a capital of 2.07 billion NTD.
Stock code: Mycenax Biotech (4726).
Company website: http://www.mycenax.com
Press Contact:
Liru Yeh
Email: liru.yeh@mycenax.com
Mycenax Biotech Inc. (4726) has reached a significant milestone. In February 2025, the company successfully passed an on-site inspection by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). Recently, Mycenax was notified by its client that the product manufactured by Mycenax has officially received PMDA’s manufacturing site transfer approval. This approval represents a major breakthrough for Mycenax’s expansion into the international market, as the company begins commercial production of a biopharmaceutical approved for sale in Japan. A long-term supply agreement has also been signed with the Japanese client, establishing a solid foundation for future revenue growth.
The site inspection was conducted by the PMDA in November 2024 at Mycenax’s Zhunan Facility, the inspection scope included GMP compliance, process validation, and quality management systems. Mycenax received official approval in February, confirming its GMP facility meets Japan’s pharmaceutical regulatory standards. The swift and successful review process highlights Mycenax’s outstanding manufacturing capabilities and high-quality standards, further strengthening its position in the global biopharmaceutical industry.
This project involved a technology transfer from the client to Mycenax. After completing all process validation requirements and consecutive GMP batch productions as required by regulatory authorities, Mycenax successfully obtained official PMDA site transfer approval. This achievement not only deepens Mycenax’s presence in the Japanese CDMO market but also marks an important milestone in the company’s expansion into Japan.
Since its strategic transformation in 2019, Mycenax has built advanced development & production biopharmaceutical technologies and a strict quality management system. Starting in 2024, the company has undergone and passed several on-site inspections by international regulatory authorities, including Japan’s PMDA and the European Medicines Agency (EMA). These achievements confirm that Mycenax’s manufacturing and quality systems are aligned with global standards. Looking ahead, Mycenax will continue to invest in innovation and international expansion, delivering reliable, high-quality solutions to partners around the world. The company will continue to invest in innovation and international growth, delivering reliable, high-quality solutions to partners around the world.
About Mycenax
Mycenax takes the CDMO brand positioning of "big D and medium M" with "Innovative development abilities (D) and Adequate manufacturing capacity (M)" to provides one-stop services for the development and manufacture of traditional biologics and novel biological drugs. At its core, Mycenax is committed to the development and production of biological drugs, from the R&D phase to cGMP manufacturing plants to drug commercialization. Mycenax, as an international CDMO company, continuously invests in product development innovations and technology platform optimizations in order to provide customers with comprehensive and streamlined CDMO services. Mycenax Biotech currently has a capital of 2.07 billion NTD.
Stock code: Mycenax Biotech (4726).
Company website: http://www.mycenax.com
Press Contact:
Liru Yeh
Email: liru.yeh@mycenax.com