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

  • Contract manufacturing, filling and packaging
  • Animal Medicines
  • North America, South America
  • 12/18/2015

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

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