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Looking for a CMO for tube single dose solution

  • 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 (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

Requirements

  • FDA

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