Packaging, labeling, and storage processes supported by specialists
SPI links overseas API (Active Pharmaceutical Ingredient) manufacturers with customers. Leveraging its long-time experience and extensive information collection capability, SPI achieves advanced GMP* control. Without being bound by the framework of a trading company, SPI provides accurate support for each process. SPI accomplishes its mission to stably supply high-quality APIs through its unique initiatives.
* GMP: Good Manufacturing Practice, signifying the standards for pharmaceutical manufacturing control and quality control
PMD Act compliance services for imported APIs
The hope of stably supplying high-quality drugs to patients is universal across borders. However, overseas API manufacturers are not always familiar with Japan’s regulatory affairs. To fulfill our mission to stably supply safe and effective products, SPI provides detailed support for overseas API manufacturers inexperienced in the Japanese market, in order to ensure compliance with Japanese pharmaceutical regulations and production conformant with approval certificates. To avoid the passive attitude of merely avoiding legal violations, we especially focus on sharing the customer-first philosophy. SPI becoming a good partner for overseas API manufacturers is the first step in becoming a good partner for patients.
Key services
Support for the registration of API MFs and approval application for the GMP inspection
Preparation and registration of the API Master Files (MFs) required by the PMD Act are major obstacles for overseas API manufacturers. We at SPI support the handling of MFs, GMP compliance inspections, and foreign manufacturer certification. We also visit the overseas sites of API manufacturers to provide instructions and guidance in person. The firm relationship of trust established in this way achieves quality assurance and stable supply.
Control of incoming and outgoing imported APIs and quality assurance
Pharmaceutical regulations in Japan have become increasingly stringent, as indicated by enforcement of the amended PMD Act in 2021. On the other hand, public trust in the entire industry has been compromised through negligence in compliance, resulting in increasingly critical views on the quality control of pharmaceuticals. Under such circumstances, SPI is promoting quality checks and inventory control with a more sincere attitude than ever. Without being bound by the framework of a trading company, SPI makes use of its internal labs and warehouses to ensure proper quality evaluation and inventory control. We respond to customer trust with the selection of proper APIs, establishment of API specifications and test methods, and other activities.
Key services
Quality assurance of imported APIs at an internal lab
Leveraging the Sumitomo Corporation Group’s global network, SPI performs quality evaluations of APIs procured from appropriate overseas partners at API Laboratory, an internal lab established at Kanagawa Science Park in Kawasaki, Kanagawa. As a testing and inspection institution with many analytical instruments, the Lab contributes to the supply of high-quality drugs.
- Click here for details regarding internal labs
Control of incoming and outgoing APIs at internal warehouses
SPI has a Tokyo Head Office Warehouse and a Yokohama Drug Warehouse, for which SPI acquired a drug manufacturer’s license. In these established storage facilities, SPI stocks APIs under GMP and stringently controls stock on behalf of its customers. These systems enable a flexible response to orders requiring short delivery times.
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