Quality Policy for Pharmaceuticals
Odawara Central Factory will strive to consistently produce quality products in compliance with GMP regulations to positively contribute to individual’s everyday health and the creation of affluent lifestyles.
Odawara Central Factory Quality Policy for Pharmaceuticals （April 1, 2022）
Stable Supply
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
Vision
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.
FY2021 Overview
In fiscal 2021, we promoted strengthening our global supply system to prepare for expansion into the increasingly important overseas market. More specifically, based on the supply and quality assurance systems we built for distribution of Viltepso in the U.S., we strengthened supply systems and prepared quality control procedures and safety information management procedures that can be applied in China, Europe, and other emerging markets as well. We also planned the establishment of a new nucleic acid API purification plant at the Odawara Central Factory as a response to rising demand in conjunction with our global expansion to establish a stable supply system based on in-house manufacturing. At the same time, to respond to the market shift to specialties and the diversification of drug modalities, we actively facilitated the use of the Odawara Central Factory and promoted the establishment of infrastructure for globalized manufacturing. Specifically, we utilized the manufacturing plant for highly active, solid formulations in product life cycle management (PLCM) for Uptravi, established a system for responding to overseas inspections of manufacturing and storage of nucleic acid APIs, and conducted training using mock inspections. We also increased the efficiency of operations and promoted labor savings by introducing robots in production facilities and using RPA. At the same time, we strengthened systems for stable supply and reduced costs by continually implementing risk management and low cost management.
FY2022 Initiatives
In fiscal 2022, we will further promote expansion into overseas markets other than the U.S. based on the global supply system infrastructure we strengthened in fiscal 2021. Specifically, we will move to build a quality assurance system and supply chain for distribution of our in-house products in the Chinese market. Moreover, in response to the rising demand accompanying global expansion, we will construct the nucleic acid API purification plant at the Odawara Central Factory and add second suppliers for APIs, formulation, and raw materials to further solidify our global supply system.
At the same time, we will continually promote risk management and low cost management, while also contributing to sustainable growth and maximization of product value through measures that go beyond those currently in place, including acceleration and greater efficiency of operations through active utilization of AI and promotion of DX.