Italian ACS re registers cefradine (sterile) raw material in China CDE
On March 10, 2025, ACS Dobbar partnered with Leawell International Limited to achieve an important milestone when the drug master file (DMF) of its cefradine (sterile) raw material was accepted by the China Center for Drug Evaluation (CDE).
In January 2020, ACS Dobfar acquired GlaxoSmithKline Manufacturing AG's antibiotic factory in Verona, Italy, as well as some product rights. This factory was established in 1932 and has been a pioneer in cephalosporin production, producing original products such as cefradine for injection, cefazolin sodium for injection, cefuroxime sodium for injection, cefonixime sodium for injection, and cefotaxime for injection. Among them, Cefuroxime Sodium for Injection and Cefotaxime for Injection are still the flagship products in this product portfolio.
ACS Dobfar has successfully upgraded and commercialized the production of cefradine (sterile). Under the cooperation with Leawell International Limited, the company is currently actively promoting the international registration, licensing, and market access of this product.
With a tradition of innovative technology, ACS Dobfar remains a leading holder of marketing authorization and a manufacturer of original and reference marketed drug (RLD) cephalosporin preparations and active pharmaceutical ingredients (API). Its product portfolio includes ceftriaxone sodium, ceftriaxone, cefazolin sodium, cefradine, cefuroxime sodium, cefaclor, cefonixime sodium, cefoxitin sodium, cefotaxime, cefotaxime/avibactam sodium, and cefotaxime axetil.