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Samyang Biopharmaceuticals Corp sell "CDMO service"

y = mx + b

Basic Information

139
10
2
4.1(72)

Trade Type

Sell

Service Name

CDMO service

Specifications

  • Purity: Meets pharmacopeial purity specifications for cytotoxic oncology APIs and injectables
  • Assay: ≥98.0% per pharmacopeial monograph
  • Impurity Profile: Controlled per ICH M7/Q3D for genotoxic and elemental impurities

Other Information

Additional Description:

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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