Focusfreda Obtains Korean Drug Registration and Factory Site Registration Certificates
Focusfreda has recently obtained Drug Registration Certificates and Factory Registration Certificates issued by South Korea’s Ministry of Food and Drug Safety (MFDS), laying a solid foundation for its Sodium Hyaluronate API to enter the Korean market.
In June, Focusfreda successfully completed the registration of two specifications of Sodium Hyaluronate API under South Korea’s Drug Master File (K-DMF) and officially received the registration certificates. This signifies that the company’s Sodium Hyaluronate API meets South Korea’s regulatory standards for product quality, safety, and production processes.
Recently, the company also completed the factory registration procedure in South Korea and officially obtained the Foreign Manufacturer Registration Notice from Korean authorities. This indicates that the MFDS has officially certified Focusfreda’s production facilities and quality management system, ensuring full compliance for exporting Sodium Hyaluronate API to South Korea.
This achievement marks a significant breakthrough in overcoming regulatory barriers in South Korea’s pharmaceutical market, not only opening doors to this important international market but also serving as an authoritative endorsement of Focusfreda’s technical strength, quality management capabilities, and global competitiveness. Currently, Focusfreda’s Sodium Hyaluronate API has successfully completed registrations in China, the European Union, South Korea, and other major pharmaceutical markets, significantly enhancing the company’s brand reputation and core competitiveness in the global API sector. This lays a valuable foundation for accelerating global market expansion and accumulating regulatory registration experience.
Looking ahead, Focusfreda will leverage this success in South Korea to further advance the registration and market access of its Sodium Hyaluronate API in key global pharmaceutical markets. The company aims to accelerate its international market, optimize service capabilities, and strive to serve more global partners.
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