07.31 2024

Tianjin Pharma received CEP certificate for betterson dipropionate raw material to broaden the scope of the international market


On May 8, Tianjin Pharma had another good news. It received a CEP certificate (Certificate of Suitability to Monograph of European Pharmacopoeia) issued by EDQM (European Directorate for the Quality of Medicines & HealthCare), on the Betomethone Dipropionate API. This means that the API meets the quality requirements of the European Pharmacopoeia and can be sold in the European market and other regulated markets that recognize CEP certificates.


It is reported that betasone dipropionate is a prodrug of the glucocorticoid drug betasone. The compound preparation composed of this product and betomethasone sodium phosphate has anti-inflammatory, anti-rheumatic and anti-allergic effects. It is mainly used clinically for the treatment of allergic and autoimmune inflammatory diseases, such as neurodermatitis, vitiligo, Urticaria, rheumatoid arthritis, lupus erythematosus, scleroderma, acute leukemia, etc.


CEP is one of the most stringent drug certifications in the world. It is also a passport for drugs to enter the EU market. It has always been known as the "green card" for the European market. CEP is not only recognized by all EU members, but also recognized by other countries that have signed bilateral agreements, such as Canada, Australia, etc.


This time, the betasone dipropionate API substance received CEP certificate, which indicates that the European regulated market recognizes and affirms the quality of this product, provides strong support for participating in global high-end market competition and further opening up incremental space in the sales market and has positive impact on the future performance of the Company.

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