Good news! Keyuan Pharma's API Lurasidone HCl was successfully transitioned to an "A" status.
Recently, Keyuan Pharma's API Lurasidone HCl passed the strict review of National Medical Products Administration (NMPA) of China and successfully transitioned to an "A" status, realizing the transition from R&D to production.
The major achievement indicates that the product is fully qualified for market launch, which not only reflects Keyuan Pharma's outstanding achievements in the field of chemical API R&D, but also demonstrates strong strength in production transformation and quality management of Keyuan Pharma.
As a high-tech enterprise focusing on the R&D, production and sales of chemical APIs and finished products, Keyuan Pharma has always been driven by scientific and technological innovation and committed to the R&D and production of high-quality APIs for 20 years since its establishment, equipped with advanced production processes and strict quality control systems to ensure that product quality reaches international advanced levels.
In terms of technology R&D, Keyuan Pharma has invested a lot of resources and established close cooperation with numerous domestic and foreign research institutions, scientific research academies, and universities. Keyuan pharma has built an international R&D team composed of industry experts and technical backbones to quickly capture cutting-edge scientific research trends and technical support, and transform them into a strong driving force for own development.
In terms of quality control, Keyuan Pharma adheres to the concept of "lean production, quality first" and builds a market-oriented and internationally integrated quality management system. Through continuous optimization and upgrading, Keyuan Pharma's core products have successively obtained the EU CEP certificate, passed the official pharmaceutical certification of the US FDA, Japan PMDA, South Korea MFDS and other many countries, and the product quality and service level have won international praise.
With cutting-edge R&D capabilities, advanced production equipment and processes, and a high-standard quality control system, Keyuan Pharma has successfully overcome multiple technical difficulties and finally achieved the successful transition of Lurasidone HCl API to an "A" status, providing stable and high-quality products and services to domestic and foreign customers.
The achievement has improved Keyuan Pharma's product line and brought significant benefits to future development. In the future, Keyuan Pharmas will continue to focus on product R&D and transition to production, further improve production processes and quality control systems, and enhance the level of large-scale production to provide global customers with better products and services.
