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Looking for partner for the development and manufacturing of medicinal D-vitamin (cholecalciferol).

  • Formulation development and drug delivery
  • Nutraceuticals
  • Europe
  • 06/30/2018

Description

Looking for partner (Europe preferred) for the development, as well as contract manufacturing of generic medicinal D-vitamin (cholecalciferol). The dosage form should be soft gelatin capsules. The preferred strengths are 4000.

Regarding the product development, we need the full development from formulation development of soft gelatin capsules , preliminary stab studies / stress tests, analytical method development and validation, manufacturing of pilot and validation batches and of course the corresponding documentation to EU-CTD dossier (modules 2.3 and 3). We also want CDMO to source API.

Also ready dossiers (with MA in EU of ready-to-file) are considered.

More information on the project and the reference product on request.

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