SPERA PHARMA was established as a spin-out of leading Japanese pharmaceutical company by Chemistry, Manufacturing and Controls (CMC) research experts, who were already responsible for delivering numerous new drugs to high global acclaim. As a member of the Bushu Pharmaceuticals Group, SPERA PHARMA is responsible for the entire CMC process, from R&D through application; it provides services that meet the needs of customers. As the development of new drugs becomes increasingly difficult, SPERA PHARMA will hone technologies it has fostered and refined, advancing the research and development of promising drugs, and helping to achieve an even healthier society through the creation of outstanding new drugs.
Chemical R&D Division of SPERA PHARMA provides "API process research and development from 'zero-level', which meets the requirement for global regulatory filing" and "seamless and consistent API manufacturing process with the quality design" by process R&D technologies with assured quality from pre-clinical stage to marketing approvals.
Pharmaceutical Technology R&D Division of SPERA PHARMA has inherited the various technologies and know-how cultivated and being put into practical use in R&D at leading Japanese pharmaceutical company, and is further deepening them. Here, representative formulation technology with concrete examples is introduced.
Analytical R&D Division of SPERA PHARMA can provide analysis and testing technology related to all stages of development from drug substance to drug product, based upon the technology and expertise cultivated over many years at the largest pharmaceutical company in the country. In addition to advanced analytical theory and instrumental analysis, detailed services are provided based on a deep understanding of the regulators in Japan, the United States and Europe.