Focusfreda obtains the EU CEP certificate for injectable-grade sodium hyaluronate active pharmaceutical ingredient
Good news! Recently, Focusfreda's injectable-grade sodium hyaluronate active pharmaceutical ingredient (API) has successfully obtained the CEP certificate (No.: CEP 2025-464) issued by the EDQM (European Directorate for Quality of Medicines and Health Care Products). This marks the company's second CEP certificate following its initial acquisition in 2023 for ophthalmic-grade sodium hyaluronate API, and represents its first-ever CEP certificate for injectable-grade sodium hyaluronate API, a milestone achievement.
The CEP certification, officially termed "Cerification of Suitability to Monograph of European Pharmacopoeia," is an independent quality assessment program initiated by EDQM for active pharmaceutical ingredients (APIs) and excipients included in the European Pharmacopoeia. The CEP certificate is recognized not only by all EU member states but also by countries that have signed bilateral agreements.
Obtaining the CEP certification signifies that Focusfreda's injectable-grade sodium hyaluronate has gained market access qualifications for the EU pharmaceutical raw material sector. This milestone represents a significant step in the company's transformation of its raw material division toward the high-end pharmaceutical-grade supply chain. It also marks a major breakthrough in Focusfreda's steadfast implementation of the group's annual work conference directives and its unwavering commitment to advancing its strategic transformation toward "pharmaceutical-grade, internationalization, and high added value," holding profound and far-reaching implications for the company's development.
Thanks to the efficient collaboration and seamless coordination of the Focusfreda registration team, the project took less than eight months—from application submission in September 2025 to obtaining the CEP certificate—shortening the typical registration cycle by nearly ten months. This not only demonstrates the high quality of the company's registration documents but also highlights its robust and reliable quality management system and exceptional product standards.
Next, under the unified leadership of the Group's dedicated task force, Focusfreda will leverage an efficient collaborative scheduling mechanism, a team committed to fulfilling its duties, and a professional spirit focused on excellence to accelerate the subsequent international registration of active pharmaceutical ingredients (APIs). This will provide strong momentum for the company to further expand its presence in global markets, including those in Europe and the United States, and to advance its transformation toward higher-end products.
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