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Looking for CMO for spot-on single dose solution

  • Contract manufacturing, filling and packaging
  • Animal Medicines
  • Europe, North America, South America
  • 12/19/2015

Description

As part of a project on behalf of one of the top ten veterinary company, we are currently looking for a CMO (Europe / North America / South America) which can provide spot-on single dose solution filled in plastic tubes protected in aluminium packs.

A full service is requested with the following process:
· Mixing (Tank + stirrer) with potential ATEX environment
· Tube Filling ( automatic line)
· Blistering
· Secondary packaging

Packaging Presentations:
· The spot on will contain endectoparasiticide
· Probably multilingual to reduce number of SKU’s
· Single Dose Plastic tubes packed in aluminium blister or sachet
o Product from 0,25ml to 3ml extractible volume
· Presentation in carton box with leaflet by 1 by 4 and multiple (24 or 36)

Customer is open to alternative solutions for primary and secondary packaging.

Annual forecast: 4 million Units WW

The company must meet following requirements:

- Regulatory and Quality: FDA mandatory EU agreement a plus // Authorization for Veterinary product
- Process and product: Alcoholic process management // Filling process with Nitrogen

Appropriate bulk batch size related to annual forecast :

o 20L for development purpose
o Up to 200 L for Industrial purpose
o CMO must have a process for 20L valid for 200L

Raw materials : Analysis and release according to US and Europe requirements

· Stability test : CMO will have to perform the VICH stability test

Please confirm if your company is able to meet such needs. If you do, thanks for sending us below information:

· Annual sales
· Indications relative to production facilities and equipments to be used
· Customer references on similar product
· Workforce
· ISO/GMP/FDA Certifications / Authorization for Veterinary product

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