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GMP-based Clinical Sample Production & Packaging

GMP-based Clinical Sample Production & Packaging

To better meet the clients' demand for a one-stop service in preparation R&D, we have established a GMP-compliant workshop for oral solid preparations capable of crushing, weighing, mixing, granulating, drying, sieving, tableting, capsule filling, coating and packaging of raw materials while improving the level of pharmaceutical production and quality management system. To enable our CDMO services, in addition to carrying out R&D, inspection and stability study of generic drugs for clients, Medicilon can also deliverproduction, packaging, inspection and stability studies of innovative drugs in clinical phases I and II.
Medicilon icon-diamond.pngServices we offer
  • Our services regarding GMP-based clinical sample production and packaging include the following. These items can be provided in modules or as a complete package.
    Raw material crushing (micronizing)Weighing - each precision balance under the weighing cover systemMixing - box-type mixing or high shear mixingGranulating - wet granulating, dry granulating and fluidized bed granulatingDrying - fluidized bed drying and oven dryingSieving -fast sieving equipmentTableting - high-speed tablet press with digital display of key parametersCapsule filling - capsule filling machine with digital display of key parameters, available for granules, powders or pellets at the same timeCoating - efficient coating machine with digital display of key parametersPackaging - aluminum-plastic packaging and bottle packaging
    The advantage of our production and packaging plant lies in its GMP-compliant management, stable and reliable product quality, traceable quality conditions, complete functions and flexible production. These factors are especially relevant for the preparation of samples for phase I clinical research.
    Medicilon’s clinical production packaging can provide product label selection for single-blind and double-blind clinical trials, and different types of clinical production packaging services that meet the current GMP standards according to clients’ requirements.
FAQ
  • What is Stability of a Drug?

    Stability of a drug refers to the degree to which the physical, chemical, biological and microbial properties of an active substance or formulation can be maintained within prescribed limits during its entire storage and use.

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