Focusfreda, a subsidiary of Freda Pharmaceutical Group, has successfully obtained the Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) for its injectable-grade sodium hyaluronate active pharmaceutical ingredient (API). The certificate number is CEP 2025-464.
This achievement represents another important breakthrough for Focusfreda following its first CEP certificate for eye drop-grade sodium hyaluronate API in 2023. It is also the first time Freda has received a CEP certificate in the field of injectable-grade sodium hyaluronate API, making it a milestone in the Group's international API development strategy.
A Recognized European Quality Certification
CEP certification, formally known as the Certificate of Suitability to the monographs of the European Pharmacopoeia, is an independent quality evaluation procedure conducted by EDQM for active pharmaceutical ingredients and excipients included in the European Pharmacopoeia.
The certificate is recognized by all European Union member states and is also acknowledged by other countries that have signed relevant bilateral agreements. For API manufacturers, obtaining a CEP certificate is an important indicator of quality system capability, regulatory compliance, and international market readiness.
Strengthening Access to the European API Market
The newly granted CEP certificate indicates that Focusfreda's injectable-grade sodium hyaluronate API has formally obtained access qualifications for the European pharmaceutical raw material market.
This progress marks a key step in Focusfreda's transformation and upgrading toward the high-end pharmaceutical-grade API value chain. It also reflects Freda Pharmaceutical Group's firm commitment to its strategic direction of pharmaceutical-grade development, internationalization, and higher value-added growth.
Advancing Freda's International API Strategy
Moving forward, Freda Pharmaceutical Group will continue to support the high-quality development of its pharmaceutical business segment. Through efficient cross-functional coordination, a dedicated professional team, and a commitment to continuous improvement, the Group will fully support Focusfreda in accelerating subsequent international API registration work.
This milestone will provide strong momentum for Freda to further expand into global pharmaceutical markets, including Europe and the United States, while continuing to move toward a higher-end and higher-value global pharmaceutical ingredient supply chain.