Nippon Shinyaku
Enhancing Quality Assurance in Intractable Disease Drug Manufacturing

Manufacturing effective and safe medications for patient treatment is a highly regulated process that necessitates compliance and adherence to strict quality norms. Continuous refinement of quality systems eliminates gaps in medicinal quality standards, guaranteeing consistency globally.

Nippon Shinyaku Co.,Ltd(NS) is an R&D-based pharmaceutical company that develops medical drugs to treat rare diseases. It has specialized in developing low molecular products and phosphorodiamidate morpholino oligomers (PMO) acceptable in U.S. and Japanese markets. The company maximizes product value by out-licensing proprietary drugs in line with regional regulations and in-licensing promising drugs manufactured by other pharmaceutical companies.

“Our focus lies in contributing to the advancement of healthcare on a global scale and greatly impacting every patient’s well-being,” says Yoshizumi Tanaka, general compliance officer of quality assurance at NS.

NS’s groundbreaking drug development practices have strategically focused on drug for intractable diseases. It has obtained approval for the first-ever PMO, Viltepso, designed for treating Duchenne muscular dystrophy. A sales and distribution system has also been established for the drug in the U.S. The company also delivers a wide range of essential drugs such as UPTRAVI^® Tablets, a treatment for pulmonaryarterial hypertension, and Defitelio^®, which was licensed from Jazz Pharmaceuticals, for treating hepatic sinusoidal obstruction syndrome in Japan.

The quality assurance process for each pharmaceutical drug at NS begins with a comprehensive understanding and adherence to different countries’ regulatory landscapes. A proactive assessment and refinement of the quality assurance protocols guarantee the delivery of high-quality pharmaceutical products.

From the developmental to post-launch stage, the NS QA team participates in the quality assurance of investigational medicinal products, process performance qualification and technical transfer engineering production to guarantee consistency in quality for small molecule drugs and PMOs.

To ensure the stability of product supply, NS QA works with the regulatory and supply chain departments. In case of critical quality events that impact supplies, the quality assurance team investigates the root cause and controls deviations in an organized way to enable rapid closures. Actions such as drug recalls and field alert reports help evaluate the quality standards across markets. A supply chain risk management process is implemented cross-departmentally to prevent risks due to drug shortages. The company is also en route to establishing a PMO purification facility at its manufacturing plant in Odawara to facilitate an efficient supply chain.

NS goes beyond compliance with good manufacturing practice (GMP) regulations and supervises every contract manufacturer as a marketing authorization holder. Regular audits confirm the compliance of contract manufacturers with the GMP system.

Our focus lies in contributing to the advancement of healthcare on a global scale and greatly impacting every patient’s well-being

Strategic partnerships with licensors, licensees and collaborators have propelled NS’s global market expansion. A notable instance is the in-house discovered product, Selexipag, sold in the global market through Johnson & Johnson Ltd. An orally available prostacyclin (PGI2) receptor agonist, Selexipag, shows long-term efficacy in pulmonary arterial hypertension by inducing vasodilation and inhibiting the proliferation of vascular smooth muscle cells.

With roots dating back over a century, NS constantly elevates product quality and refines its quality systems to ensure its products’ global accessibility. It remains committed to developing premium pharmaceutical medicines to cure ailments and improve patient access to these drugs. Leveraging its robust foundation in quality assurance and a vision for the future, NS continues to make significant strides in advancing medical solutions that cater to diverse healthcare needs.