Quality Policy for Pharmaceuticals
To help people lead healthier, happier lives, we ensure a stable supply of products that satisfy our customers while observing all related laws and regulations and assuring high product quality and reliability.
We continue to develop and improve our systems so as to ensure a rapid and stable supply of quality pharmaceutical drugs through advanced supply chain management, covering from production and quality to logistics.
Manufacturing Base in Japan Odawara Central Factory
Achieving cost and quality competitiveness as a manufacturing site
Constantly upgraded with the latest equipment and systems, the Odawara Central Factory produces highly reliable pharmaceutical drugs that meet international standards, including Nippon Shinyaku’s mainstay treatment drugs for blood cancer and pulmonary arterial hypertension.
In 2017, the Odawara Central Factory saw the completion of a highly active solid formulation manufacturing plant, which commenced integrated manufacturing in the following year. With its already advanced technological capabilities further reinforced with the manufacturing of highly active solid formulations, the Odawara Central Factory strives to maximize customer satisfaction. It also promotes initiatives to enhance overall supply chain productivity, including the doubling of API sources.
In logistics, the Odawara Central Factory maintains a reliable supply system considerate of not only quality but also disaster preparedness through various measures, including accurate temperature regulation during storage and transportation and dispersed inventory storage.
Global Supply Chain
To build a foundation for continued growth, it is essential to vigorously pursue global development. Given the ever- challenging environment of the Japanese pharmaceutical market, overseas markets, such as the United States, Europe, and China and other newly emerging economies are becoming increasingly important for Nippon Shinyaku. For the launch of Viltepso in the United States in FY 2020, the Odawara Central Factory played an important role in the company’s global development, working closely with NS Pharma, Inc., the Nippon Shinyaku subsidiary in the United States, receiving FDA inspections at related manufacturing sites, building a sales network in the United States, and putting in place systems for handling legal formalities . Global supply and reliability assurance systems were thus established.
FY 2019 Overview
Building global supply and reliability assurance systems for Viltepso and improving productivity
FY 2019 was marked with preparation for the launch of Viltepso in the United States in FY 2020. This involved building global supply and reliability assurance systems. Concretely, we completed such steps as receiving FDA inspections at related manufacturing sites, building a sales network in the United States, putting in place systems for handling legal formalities, and establishing a safety database and its operating procedure. Furthermore, in view of future utilization of the company’s own manufacturing facilities, an analytical study was conducted to gauge the gap between the Odawara Central Factory and global operation, with a team formed to respond to the findings.
The stable supply system, operational efficiency improvement, and cost management that we achieved in the previous Mid-term Management Plan were further reinforced so as to improve the overall productivity of our supply chain. Specifically, we applied the quality management system vigorously to ensure the quality, efficacy, and safety of APIs and products. We also pursued low-cost management by reducing the material procurement and logistics costs of our main products. Our business continuity plan (BCP) was actively promoted to prevent product supply interruption, with risk reduction through inventory target maintenance and supplier management and emergency manual review.
Future Prospects for Production
Focus on global supply system construction, new investments related to nucleic acid drugs, and more
As the situation of the Japanese pharmaceutical market becomes increasingly challenging, the company is more intensely looking toward overseas markets in the United States, Europe, and China and other newly emerging economies. For active expansion into these markets, we are working on the construction of global supply systems, logistics systems capable of Good Distribution Practices (GDP) for pharmaceutical products, and a reliability assurance system capable of regulatory responses, including handling of inspections by overseas authorities.
In view of a shift to specialty areas of the market and the diversification of pharmaceutical modalities, we are envisaging a more active utilization of the Odawara Central Factory. Concretely, we are promoting the use of the highly active solid formulation manufacturing plant in the product life cycle management (PLCM) of selexipag and are surveying potential new investments related to nucleic acid drugs.
We are pursuing these moves while continuing our cost management efforts to reduce procurement and logistics costs, thereby increasing profits.