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Samyang Biopharmaceuticals Corp sell "CDMO service"

y = mx + b

基本信息

139
10
2
4.1(72)

交易类型

出售

服务名称

CDMO service

规格参数

  • Purity: 符合肿瘤细胞毒性原料药及注射剂的药典纯度标准
  • 含量测定(Assay): 依据药典专论≥98.0%
  • 杂质谱: 依据ICH M7/Q3D控制基因毒性及元素杂质

其他信息

补充描述:

This oncology CDMO service covers cytotoxic injectables as lyophilized or liquid vials. The current plant holds EU GMP, JGMP, KGMP, and PIC/S certification and produces cytotoxic APIs and injectables (liquid and lyophilized vials) at a 10-200 L bulk solution scale in vial sizes from 0.5 to 50 mL, while a new plant (construction completing by end of 2020) targets cGMP certification with capacity of 30-300 L bulk solution across the same vial range; full EU and Japan dossiers are available for paclitaxel, oxaliplatin, and docetaxel, with other oncology injectable formulations possible, and approvals already in place in the EU and Japan.
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