NEWS CENTER

Great news! Keyuan Pharmaceutical's API, Rulacizone Hydrochloride, has successfully transitioned to Phase A!

Publish Time:

2024-11-02

This significant achievement marks that the product is now fully ready for market launch, showcasing not only Keyuan Pharmaceutical's outstanding success in the field of chemical API R&D, but also highlighting its strong capabilities in production transformation and quality management.

Recently, Keway Pharmaceutical (stock code: 301281.SZ)’s raw material drug lurasidone hydrochloride successfully passed the rigorous review by the National Medical Products Administration and was officially upgraded to Category A, marking a significant milestone in its seamless transition from research and development to full-scale production.

As a high-tech enterprise dedicated to the R&D, production, and sales of chemical APIs and their formulated products, Keyuan Pharmaceutical has remained steadfastly committed to driving innovation through science and technology over the past two decades. We are devoted to developing and manufacturing high-quality APIs, equipped with cutting-edge production processes and a rigorous quality-control system that ensures our products meet globally advanced standards.

In terms of technological research and development, Keyuan Pharmaceutical has invested heavily in resources and established close collaborations with numerous domestic and international R&D institutions and academic organizations. This has enabled the company to build an international R&D team composed of industry experts and technical leaders, allowing it to swiftly capture cutting-edge scientific advancements and technical support—and turn them into a powerful driving force for its own growth and innovation.

In terms of quality control, Keyuan Pharmaceutical adheres to the philosophy of "lean production, quality first," and has established a market-oriented, internationally aligned quality management system. Through continuous optimization and upgrades, the company's core products have successively earned the EU CEP certificate and passed official pharmaceutical regulatory approvals from multiple countries, including the U.S. FDA, Japan’s PMDA, and South Korea’s MFDS. As a result, the company’s product quality and service standards have garnered widespread international acclaim.

Leveraging cutting-edge R&D capabilities, advanced production equipment and processes, and a high-standard quality control system, Keyuan Pharmaceutical has successfully overcome multiple technical challenges, ultimately achieving the successful transfer of lurasidone hydrochloride API to Phase A. This enables us to provide customers—both domestically and internationally—with stable, high-quality products and services.

This achievement has strengthened Kexuan Pharmaceutical's product pipeline, bringing significant benefits to the company's future growth. Moving forward, Kexuan Pharmaceutical will continue to focus on innovative R&D and the successful commercialization of its products, further refining its manufacturing processes and quality control systems, while enhancing its capacity for large-scale production. This will enable us to deliver even higher-quality products and services to customers worldwide.

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