Recently in the pharmaceutical industry, there have been new movements that were not observed before, such as the selection and concentration of development targets, development of new modalities in addition to small molecule drugs, cost reduction required for intensified competition, and environment-friendly manufacturing. We at SPI select the most appropriate partners from Japan, Europe, the U.S., China, India, South Korea, and other countries in accordance with customers’ needs and product characteristics to provide support for the procurement and contract production of intermediates. While we most frequently handle raw materials, GMP* starting materials, and advance intermediates in the early development stage to the commercialization of small molecule drugs, our portfolio also includes various pharmaceutical intermediates for middle molecule drugs, oligonucleotide therapeutics, gene therapy, antibodies, etc. We also introduce partners capable of continuous manufacturing and FTE** service aimed at speed-up of the development, which has drawn much attention these days, thereby supporting the resolution of diverse customer issues. * GMP: stands for Good Manufacturing Practice, signifying the standards for pharmaceutical manufacturing control and quality control ** FTE: stands for Full Time Equivalent, signifying the retention of dedicated researchers for testing for a specified time

The environment surrounding pharmaceutical administration has substantially changed and the advanced function and quality are required for inport of APIs. Based on our extensive information collection capability utilizing the Sumitomo Corporation Group’s global network, we at SPI select the most appropriate partners from Japan and overseas in accordance with customers’ needs and product characteristics to provide support for the procurement and contract production of APIs. We especially provide overseas manufacturers with information concerning pharmaceutical administration and drug market trends in Japan, as well as support on-site manufacturing control and quality control. We are also capable of selecting proper APIs and setting specifications and testing methods based on quality testing at our API Laboratory. We also have a storage facility for imported APIs and provide customers with enhanced support based on API stocks stored under GMP control.

Drug excipients and additives refer to substances other than APIs contained in drugs, and are important drug components for drug formulations. These substances do not have pharmacological effects but are indispensable materials in drug production, not only providing benefits such as making drugs easier to take (by masking bitterness or smell, etc.), improving quality stability, and achieving stable release of APIs, but also facilitating drug formulation. Utilizing the Sumitomo Corporation Group’s global network, we at SPI provide various drug exipients and additives from Japan and overseas, including CEOLUSTM produced by Asahi Kasei Corporation, other excipients, disintegrants, taste masking agents, coating agents, bases, adhesives, and emulsifiers/solubilizers.

As a drug manufacturer (packaging, labeling, and storage categories), our Regulatory Compliance & Quality Assurance Dept. handles quality control, manufacturing control, audits, and regulatory affairs with regard to manufacturing. The Department consists of the API Laboratory, Regulatory Affairs Group, and Manufacturing Control Group. The API Laboratory is a testing and inspection institution for quality evaluation of APIs imported by SPI, and is located in Kanagawa Science Park in Kawasaki, Kanagawa. At the Laboratory, we perform API quality tests, set specifications and testing methods, and handle other activities using many instruments that conform to applicable laws and regulations. The Regulatory Affairs Group provides support in regulatory affairs, including certification of foreign manufacturers required by the PMD Act, registration of Master Files (MFs), GMP compliance inspection at API manufacturing sites in Japan and overseas, and formulating a response to audits by marketing authorization holders. The Manufacturing Control Group undertakes overall manufacturing control required by the PMD Act at the Tokyo Head Office Warehouse and the Yokohama Drug Warehouse, for which we have acquired a drug manufacturer’s license.