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Looking for a CMO for sterile solution for injection in colorless Glass

  • Contract manufacturing, filling and packaging
  • Human Medicines, Animal Medicines
  • Europe, North America, South America
  • 02/03/2016

Description

As part of a project on behalf of one of the top ten veterinary company, we are currently looking for a CMO (North America or South America) which can provide a sterile solution for injection in Colourless Glass. (antibiotic) A full service is requested with the following process: • Mixing • Heating • Cooling • Aseptic filling • Secondary packaging Packaging Presentations: • Multidose solution for injection • VIAL : Colourless Glass type I • VIAL SIZES : 50 ml, 100 ml, 250 ml, and 500 ml • Final packing : Box of one unit Annual forecast: 100 000 Units, app. 20 000 L The company must meet following requirements: • Regulatory and Quality : o FDA agreement mandatory, Europe and other countries a plus o Authorization for Veterinary product • Process and product : o Appropriate bulk batch size related to the annual sales : 500L to 1500L • Sterilizing filtration (aseptic process) • Manufacturing : Heating and Cooling (system) vessel • Manufacturing and Filling process under Nitrogen • Filling: capability from or 50ml up to 500ml (vials) • Raw materials and Finished product : Analysis and release according to US requirements • CMO will have to perform the VICH stability test Please confirm if your company is able to meet such needs. If so, thanks for sending us below information: • Annual sales • Workforce • Indications relative to production facilities and equipments to be used • Customers references on similar product • ISO/GMP/FDA Certifications / Authorization for Veterinary product

Requirements

  • FDA

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