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Looking for CMO for production of risperidone and placebo for clinical trials

  • Contract manufacturing, filling and packaging
  • Human Medicines
  • Europe
  • 01/16/2014

Description

Production and supply of placebo and risperidone for clinical trials in childhood cohorts. Packaging and labelling can be done separately at another CRO already contacted. What is needed is either acquisition of 1) commerically available risperidone and GMP manufacture of matching placebo or 2) overcoating of both commercially acquired risperidone and GMP manufactured placebo or 3) GMP manufacture of both risperidone and placebo. The number of tablets needed for the study and the doses required is listed below; but in total 300,000 risperidone tablets are needed and 98,000 placebo tablets. Dose of risperidone 0.25mg / 0.5mg / 1.0mg = number of tablets 104,000 / 155,500 / 40,500. The matching placebo for the 0.25/0.5/1.0 mg doses should contain the following number of tablets 26,500 / 55,000 / 16,500. The current order is under a very short stop / go decision making process and quotations are needed no later than 12/01/2014. Furthermore, capacity should be available to fulfill this order by 01/05/2014.

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