Recently, Shandong Xinhua Pharmaceutical Co., Ltd. (hereinafter referred to as "Xinhua Pharmaceutical" or "the Company") has received the FDA Registration Approval Letter for Sevelamer Carbonate Active Pharmaceutical Ingredient (hereinafter referred to as "the Product"), which was officially verified and issued by the U.S. Food and Drug Administration (FDA). The relevant details are hereby announced as follows:
I. Basic Information
Drug Name: Sevelamer Carbonate
Drug Category: Active Pharmaceutical Ingredient (API)
Registration Classification: Chemical Drug
Applicant: Shandong Xinhua Pharmaceutical Co., Ltd.
Application Item: Marketing Authorization Application for Chemically Synthesized API Produced Domestically
Drug Master File (DMF) Number: 035326
Approval Conclusion: The review of the Drug Master File for Sevelamer Carbonate API has been completed with no further issues identified, and the product is approved for marketing.
II. Other Relevant Information
In November 2020, Xinhua Pharmaceutical submitted the DMF of the Product to the U.S. Food and Drug Administration (FDA) and obtained the registration number. In November 2024, the Company received the Drug Registration Approval Letter, with the review conclusion confirming that the DMF has been approved and taken effect.
Sevelamer Carbonate is indicated for the control of hyperphosphatemia in adult patients with chronic kidney disease (CKD) undergoing dialysis. It is a non-absorbable phosphate-binding cross-linked polymer that contains no calcium or other metals. It adsorbs phosphate in the gastrointestinal tract through ion exchange, and the resulting complexes are excreted via feces with no systemic absorption, ensuring a high safety profile.
Sevelamer Carbonate Tablets, originally developed by Sanofi Genzyme, have been marketed and widely used in more than 40 countries including the United States, Japan, Canada and European nations. Sevelamer Carbonate is currently the only next-generation phosphate binder approved by the U.S. Food and Drug Administration (FDA) that contains neither calcium nor other metals, and it is consistently recommended as the first-line agent for phosphate reduction in clinical guidelines and standards both domestically and internationally. According to relevant statistics, the global consumption volume of Sevelamer Carbonate API reached over 600 metric tons in the 12-month period ending March 31, 2024.
