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与Leawell International Limited合作,在中国药品审评中心(CDE)受理了其头孢拉定(无菌)原料药的药品主档案(DMF)时,实现了一个重要的里程碑。
2020年1月,ACS Dobfar收购了葛兰素史克制造股份公司在意大利维罗纳的抗生素工厂,以及部分产品权利。该工厂成立于1932年,一直是头孢菌素生产的先驱,生产注射用头孢拉定、注射用头孢唑林钠、注射用头孢呋辛钠、注射用头孢尼西钠和注射用头孢他啶等原研产品。其中,注射用头孢呋辛钠和注射用头孢他啶仍是该产品组合中的旗舰产品。
ACS Dobfar公司已成功升级并商业化头孢拉定(无菌)的生产。在与Leawell International Limited的合作下,该公司目前正积极推进该产品的国际注册、许可和市场准入工作。
凭借创新技术的传统,ACS Dobfar 仍是领先的上市许可持有者,也是原研药和参考上市药物(RLD)头孢菌素制剂和活性药物成分(API)的制造商。其产品组合包括头孢噻吩钠、头孢氨苄、头孢唑林钠、头孢拉定、头孢呋辛钠、头孢克洛、头孢尼西钠、头孢西丁钠、头孢他啶、头孢他啶/阿维巴坦钠和头孢他洛林酯。