Focusfreda's injectable-grade sodium hyaluronate active pharmaceutical ingredient has successfully obtained the Export to EU Active Pharmaceutical Ingredients (WC) certification.

Good news! Recently, Focusfreda's injectable-grade sodium hyaluronate active pharmaceutical ingredient (API) has successfully obtained the export certificate for EU APIs issued by the Shandong Provincial Drug Administration (WC Certificate, No.: SD260041). This marks another significant breakthrough for the company in the field of international compliance for high-end APIs, following the acquisition of the WC certificate for ophthalmic-grade sodium hyaluronate API in 2024. It signifies that the company's injectable-grade sodium hyaluronate products have officially obtained regulatory approval for entry into the EU market, laying a solid compliance foundation for further expansion into Europe's high-end pharmaceutical sector and global industrial development.

The WC certificate is issued in accordance with China's pharmaceutical regulatory regulations and the regulatory requirements of the EU's Directive 2001/83/EC. It serves not only as a mandatory "pass" for China's active pharmaceutical ingredient (API) products to enter the EU pharmaceutical market but also represents high-level authoritative recognition by the EU's drug regulatory system of the quality and compliance standards of domestic API production. The successful acquisition of this certificate fully demonstrates Focusfreda's comprehensive compliance management capabilities throughout the entire lifecycle of its injectable-grade sodium hyaluronate API—from research and development, production, testing, storage to release. Its quality management system fully complies with international high standards such as China GMP, EU GMP, and ICH Q7, ensuring stable, controllable, safe, and compliant product quality, as well as robust capabilities for large-scale, standardized exports to the EU market.

Looking ahead, Focusfreda will use this certification as a new starting point to further deepen its expertise in high-end active pharmaceutical ingredient (API) research and development as well as precision manufacturing, strictly adhere to export compliance standards, and continuously strengthen its international compliance capabilities. The company will pursue deeper market expansion in the EU with higher standards, cultivate high-quality overseas partnerships, steadily increase its global market share, provide sustained momentum for the solid implementation of its internationalization strategy, and deliver premium pharmaceutical raw materials to advance global healthcare initiatives.

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E-mail：sales@focuschem.com
Add：Economic Development Zone, High-speed Railway New District, Qufu City, Jining City, Shandong Province, China

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