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.