On March 10, 2025, ACS Dobfar, in partnership with Leawell International Limited, achieved a significant milestone when China’s Center for Drug Evaluation (CDE) accepted the Drug Master File (DMF) for its Cefradine (Sterile) API.
In January 2020, ACS Dobfar acquired GlaxoSmithKline Manufacturing S.p.A.’s antibiotic facility in Verona, Italy, along with select product rights. Established in 1932, this plant has been a pioneer in cephalosporin production, manufacturing originator products such as cefradine for injection, cefazolin sodium for injection, cefuroxime sodium for injection, cefonicid sodium for injection, and ceftazidime for injection. Cefuroxime sodium and ceftazidime for injection remain flagship products from this portfolio.
ACS Dobfar has successfully updated and commercialized the production of Cefradine (Sterile). In collaboration with Leawell International Limited, the company is now advancing international registration, licensing, and market entry initiatives for this product.
With a legacy of innovator technologies, ACS Dobfar remains a leading marketing authorization holder and manufacturer of originator and Reference Listed Drug (RLD) cephalosporin formulations and active pharmaceutical ingredients (APIs). Its portfolio includes cefalotin sodium, cefalexin, cefazolin sodium, cefradine, cefuroxime sodium, cefaclor, cefonicid sodium, cefoxitin sodium, ceftazidime, ceftazidime/avibactam sodium, and ceftaroline fosamil.
2025年3月10日，ACS Dobfar與Leawell International Limited合作，在中國(guó)藥品審評(píng)中心（CDE）受理了其頭孢拉定（無菌）原料藥的藥品主檔案（DMF）時(shí)，實(shí)現(xiàn)了一個(gè)重要的里程碑。
2020年1月，ACS Dobfar收購(gòu)了葛蘭素史克制造股份公司在意大利維羅納的抗生素工廠，以及部分產(chǎn)品權(quán)利。該工廠成立于1932年，一直是頭孢菌素生產(chǎn)的先驅(qū)，生產(chǎn)注射用頭孢拉定、注射用頭孢唑林鈉、注射用頭孢呋辛鈉、注射用頭孢尼西鈉和注射用頭孢他啶等原研產(chǎn)品。其中，注射用頭孢呋辛鈉和注射用頭孢他啶仍是該產(chǎn)品組合中的旗艦產(chǎn)品。
ACS Dobfar公司已成功升級(jí)并商業(yè)化頭孢拉定（無菌）的生產(chǎn)。在與Leawell International Limited的合作下，該公司目前正積極推進(jìn)該產(chǎn)品的國(guó)際注冊(cè)、許可和市場(chǎng)準(zhǔn)入工作。
憑借創(chuàng)新技術(shù)的傳統(tǒng)，ACS Dobfar 仍是領(lǐng)先的上市許可持有者，也是原研藥和參考上市藥物（RLD）頭孢菌素制劑和活性藥物成分（API）的制造商。其產(chǎn)品組合包括頭孢噻吩鈉、頭孢氨芐、頭孢唑林鈉、頭孢拉定、頭孢呋辛鈉、頭孢克洛、頭孢尼西鈉、頭孢西丁鈉、頭孢他啶、頭孢他啶/阿維巴坦鈉和頭孢他洛林酯。
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