Views: 0 Author: Site Editor Publish Time: 2025-11-04 Origin: Site
A Chinese API manufacturer has recently achieved a significant milestone as its Dexamethasone sodium phosphate (CAS 55203-24-2) API product received the Certificate of Suitability to the European Pharmacopoeia (CEP). This certification confirms that the product complies with the strict quality standards of the European Pharmacopoeia, reflecting the recognition of the European market for its manufacturing process, consistency, and purity. With this approval, the Dexamethasone sodium-phosphate API can now be legally supplied to all European Union member states and other markets that recognize the CEP certificate — marking a crucial step in expanding China’s pharmaceutical export capacity and strengthening the position of domestic pharmaceutical raw material suppliers in the global industry.
Dexamethasone sodium phosphate is a synthetic glucocorticoid steroid widely used for its anti-inflammatory, anti-allergic, anti-rheumatic, and immunosuppressive properties. As a potent corticosteroid, it plays a vital role in the management of numerous inflammatory and autoimmune diseases, including connective tissue disorders, active rheumatism, rheumatoid arthritis, systemic lupus erythematosus, severe bronchial asthma, ulcerative colitis, and various dermatologic conditions. In addition, it is often applied as part of combination therapy in acute leukemia, malignant lymphoma, and certain severe infections or poisoning cases.
The CEP certification is one of the most authoritative quality recognitions in the pharmaceutical industry. It ensures that the API manufacturing process, impurity control, and analytical methods all meet EMA and EDQM standards. For Dexamethasone phosphate steroid producers, achieving CEP status demonstrates a high level of manufacturing capability, transparency, and traceability — all critical for gaining regulatory trust in Europe and other international markets.
This certification will also accelerate partnerships between Chinese active pharmaceutical ingredient manufacturers and global formulation companies seeking reliable and high-quality corticosteroid APIs. It allows streamlined Drug Master File (DMF) referencing and simplifies product registration procedures in regulated markets.
The certified Dexamethasone sodium-phosphate API product benefits from an optimized synthesis process that enhances yield, minimizes residual solvents, and ensures batch-to-batch stability. Continuous improvement in crystallization and purification techniques has led to a highly pure, stable product suitable for both injectable and oral formulations. Moreover, several pharmaceutical raw material suppliers in China have adopted greener chemistry principles, reducing solvent waste and improving environmental compliance, aligning with the European Union’s sustainability expectations.
This milestone reflects the growing competitiveness of China’s API manufacturers in regulated markets such as the EU, Japan, and the U.S. The addition of Dexamethasone sodium phosphate to the list of CEP-certified APIs reinforces China’s role not only as a global production base but also as an innovation-driven force in high-quality pharmaceutical raw materials.
As international demand for corticosteroid APIs continues to rise, this achievement will enable greater collaboration between global pharmaceutical partners and Chinese suppliers, further advancing the accessibility of reliable, high-purity Dexamethasone phosphate steroid ingredients worldwide
