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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.
