Small Molecule Facility
Facilities List
Juzen Pharmaceutical Plant-Ⅰ
A multi-purpose active pharmaceutical ingredient (API) manufacturing facility that complies with PIC/S GMP. Between 2000 and 2019, the facility underwent multiple FDA GMP inspections and received high praise for its advanced GMP management. We have established a manufacturing management system aligned with global standards, enabling us to effectively meet the demands of international customers.
Juzen Pharmaceutical Plant-Ⅱ
A multipurpose manufacturing facility for active pharmaceutical ingredients (APIs) and intermediates that complies with PIC/S GMP. The facility underwent multiple FDA GMP inspections between 2005 and 2019, receiving high praise for its advanced GMP management. We have developed a manufacturing management system that adheres to global standards, enabling us to meet international demands effectively.
Juzen Pharmaceutical Plant-Ⅲ
A containment-equipped multipurpose plant designed to handle highly potent active pharmaceutical ingredients (HPAPIs). The facility is structured to provide exposure control tailored to the hazard levels of drug substances, effectively minimizing both cross-contamination risks and health risks for workers. In August 2024, the plant completed an expansion project to enhance its manufacturing capabilities for small-molecule APIs and intermediates, as well as to establish a dedicated manufacturing area and equipment for oligonucleotide production.
Juzen Hydrogen Plant
JHP is dedicated to hydrogenation reactions and ultra-low temperature reactions. A wide range of scale reactions are carried out in this dedicated plant.
Warehouse
September 2024, a warehouse building equipped with various storage facilities, including automated racks designed for temperature control between 15–25°C, as well as refrigerated and frozen storage units, was completed.
Analytical Facility
The Quality Control Department is equipped with state-of-the-art testing instruments to verify the chemical quality and powder properties of drug substances. Additionally, microbiological testing facilities and laboratories for highly pharmacological activity substances are in place, ensuring a robust quality evaluation system. Beyond quality testing, we support new drug development by facilitating analytical method transfer from contract givers, conducting method validation, and developing analytical methods, contributing to shorter development timelines. In 2024, we introduced a Laboratory Information Management System (LIMS) to further strengthen our data integrity (DI) efforts.
Research Facility
Juzen Chemical leverages its extensive experience and expertise to develop safe, robust, and highly productive processes, contributing to the acceleration of new drug development and improved efficiency in API manufacturing. Our experienced research staff, drawing on long-established knowledge of process chemistry and process engineering, engages in the research and development of innovative processes.