Good News! Dorra Pharmaceuticals’ Self-Developed Fosfomycin Trometamol API Receives EU CEP Certification, Further Strengthening Its Leadership in the Global Fosfomycin Market

發(fā)布時間： 2025-07-04 閱讀：59次

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Dorra Pharma is proud to announce that its self-developed core active pharmaceutical ingredient (API), Fosfomycin Trometamol, has been granted a Certificate of Suitability to the European Pharmacopoeia (CEP) (Certificate No. 2024-168-Rev00) by the European Directorate for the Quality of Medicines & HealthCare (EDQM). This milestone underscores that our quality system, manufacturing processes, and product fully comply with European Pharmacopoeia standards, paving the way for broader access to the EU and other highly regulated global markets.

As a pioneer in the fosfomycin industry chain, Dorra has long maintained a strong position in the fosfomycin intermediate market, with substantial global market share. Through continuous technological innovation, rigorous quality control, and reliable supply, Dorra has earned the trust and recognition of pharmaceutical partners worldwide.

The award of the EU CEP for Dorra’s Fosfomycin Trometamol API stands as a high-level validation of its international quality standards. Widely recognized across Europe and ICH member countries, the EU CEP serves as a key benchmark for API market entry. This milestone underscores not only the superior quality of this API, but also highlights Dorra’s advanced R&D capabilities, robust quality management, and global strategy, further solidifying its leadership in the global fosfomycin sector.

This CEP certification is both a recognition of past achievements and a new starting point for future growth. Dorra will continue to expand its portfolio of APIs and advanced intermediates in therapeutic areas such as cardiovascular, anti-infective, central nervous system, and antidepressant treatments. The company remains dedicated to driving R&D innovation, enhancing quality systems, and accelerating global market reach.

Guided by the philosophy of “Benchmarking Global Quality, Driving the Future with Innovation.” Dorra aims to be a trusted, innovation-driven API partner, delivering greater value for life and health worldwide.

Dorra warmly welcomes inquiries and collaboration opportunities from partners around the globe.