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IMP MANUFACTURING

RenaClinical has a wide range of manufacturing and packaging capabilities within their MHRA approved UK facility.   The manufacturing facility & equipment has been designed for small scale and large scale batch production to accommodate early phase and late phase clinical trials.  All manufacturing is performed in new state of the art cleanroom facilities using validated pharmaceutical-grade equipment.

Tablet Manufacturing

  • Matched placebo or active tablets

  • Tablet sizes from 5mm to 25mm diameter in a wide range of shapes are available. Download our shape guide for further information

  • Immediate, sustained and modified release tablets

  • Single punch or rotary tablet presses enable tablet manufacturing speeds from 1,000 to 40,000 per hour

  • Pre-formulated tablet mixes available to reduce lead time for early phase active tablet production

  • Existing stability data for placebo tablets

Tablet Coating

  • Film coating and sugar coating capabilities for effective active tablet matching

Capsule Manufacturing

  • Over-encapsulation of tablets & capsules

  • Existing placebo capsule formulations with enhanced stability data using a wide range of capsule shells and sizes

  • Neat-filled API capsules for early phase drug development

  • Automated and semi-automated capsule filling equipment

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Liquid Manufacturing

  • Topical and Oral liquid manufacturing including suspensions and solutions

  • Bulk liquid pack-downs via semi-automated filling lines

  • Matched placebo solutions and suspensions

Packaging and Labelling

  • Primary packaging into bottles, tubes, blisters and sachets into a wide range of container sizes

  • Induction sealing of bottles

  • Secondary packaging including randomisation and blinding processes

  • Manual and semi-automatic packaging processes

  • Manual packaging of complex patient kits

  • Multi-language labels including booklet labels and barcode labelling capabilities

Sterile Manufacturing (via 3rd Parties)

A wide range of sterile manufacturing activities can be performed via our approved 3rd party contact manufactures located in the UK, US and EU.  Terminal sterilization, aseptic filtration and freeze-drying capabilities are available in a wide range of batch sizes to accommodate all stages of the product lifecycle.

Get in touch for more information or your FREE QP consultation 

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