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ANFARM HELLAS S.A. sell "Ertapenem Pd.C.So.In 1g/Vial (under development)"

基本信息

553
26
12
3.8(41)

交易类型

出售

产品名称

Ertapenem Pd.C.So.In 1g/Vial (under development)

规格参数

  • Sterility: 符合USP <71>/Ph.Eur. 2.6.1对注射剂产品的无菌检查要求。
  • Bacterial Endotoxins: 符合USP <85>/Ph.Eur. 2.6.14细菌内毒素限度要求,经验证的LAL法确认。
  • Particulate Matter: 符合USP <788>/Ph.Eur. 2.9.19不溶性微粒限度要求。
  • Container Closure Integrity: 容器密封系统经验证,可在有效期内保持无菌性与产品完整性。

其他信息

补充描述:

Ertapenem 1 g powder for concentrate for solution for infusion, referencing Invanz (MSD). Ertapenem is a carbapenem antibiotic indicated for pediatric patients and adults for infections caused by bacteria known or highly likely to be susceptible, when parenteral therapy is required, including intra-abdominal infections, community-acquired pneumonia, acute gynecological infections, and diabetic foot skin/soft-tissue infections, and in adults for prophylaxis against surgical site infection following elective colorectal surgery. The dossier is in progress with timelines to be defined, stability studies cover Zone II and Zone IVb, the originator's shelf life is two years, and batch and pack sizes are to be determined (originator packs of 1 or 10 vials).
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