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GMP-based Clinical Sample Production & Packaging

GMP-based Clinical Sample Production & Packaging

In order to better meet the clients' demand for 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. In that way, we cannot only carry out the R&D, inspection and stability study of generic drugs for clients, but also promise the R&D, production, packaging, inspection and stability study of innovative drugs in clinical phases I and II to enable our CDMO services.
Medicilon icon-diamond.pngService
  • Our services regarding GMP-based clinical sample production and packaging mainly include the following. These items can be provided in modules or as a whole.
    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 parameters.Packaging - 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, especially suitable 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.
  • 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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