Clinical Trial Material Manufacturing, Packaging & Labeling

WuXi AppTec clinical trial material (CTM) manufacturing facilities are designed for production of Phase I and Phase IIB materials. WuXi AppTec currently manufactures solid oral (including liquid filled hard gelatin capsules), sachets, liquid oral and topical semi-solid dosage forms.

Capabilities

  • The GMP facility complies with US FDA, EMEA and SFDA requirements
  • Over-encapsulation of tablets and capsules for blinded clinical supplies
  • Expanded capacity offers multiple product manufacturing simultaneously which allows handling different products in parallel without delaying in clinical supplies
  • Facility capable of handling with hygroscopic and light sensitive compounds
  • Successfully supplied over 400 clinical supplies in different parts of world without any delays; clinical supplies have been sent to USA, UK, EU, Australia, Thailand, Korea, and China
  • Experience in handling compounds with different exposure control limits (ECL)

Clinical Trial Materials Packaging

WuXi AppTec’s state-of-the-art cGMP CTM packaging formats:

  • HDPE Bottles followed by induction sealing
  • Bottles with screw caps including CRC caps
  • Thermoforming blisters (PVC/PVDC/Aclar/Trilamintes-Alu)
  • Cold forming blisters (Alu-Alu) in different formats
  • Sachets

Clinical Trial Materials Secondary Packaging & Labeling

WuXi’s CTM packaging can provide single window and double blind clinical trial material labeling options. We can also perform secondary packaging in different formats based on client requests.