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  • Tech request D-564
  • Posted on: 27/03/2012
  • Deadline : 28/06/2012
  • Active users : 3026
  • Organization type

    Large companies

  • Type of technology request

    R&D projects

  • Deadline

    28/06/2012 - The deadline of this tech request has expired

  • Domains of knowledge

    Life sciences

Desired outcome

The aim is to develop a Bioequivalent and Stable multidose pharmaceutical high potency generic product in the time frame agreed between both companies based on milestones. The product should be scaled up to industrial facilities running the process with the following technology: direct blend, wet granulation (water or organic), fluid bed drying,… The company offering the proposal should be able to generate the necessary documentation to register the product in regulated european markets and FDA. Solutions presented should contain an innovative approach development proposal for a generic product with a detailed go - no go decision points based on a Risk Assessment Study. A joint development might be considered.

Spanish Pharmaceutical company with more than 900 employees present in more than 53 countries worldwide. We are partners with 60 R&D Centers and universities all over the world. In 2011, the companyś sales reached 311 million € and we invested 12 million € in R&D&i.

Possible solution areas

  • Pharmaceutical development companies

  • University spin offs

Details of the tech request

Solutions presented should contain an innovative approach development proposal for a generic product with a detailed go - no go decision points, using design of experiment as a tool based on a Risk Assesment Study. Presently we develop our projects following normally the same patern: from t=0 - api disponibility, to proof of concept, it takes about 6 months. We choose the best concept using in vitro dissolution profiles technology, and pre-stability testing. At this point we...

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