Manufacturing

With a wholly owned automated manufacturing facility now established in Sydney, Recce Pharmaceuticals is well placed to produce product in volumes to support planned Phase I and Phase II clinical trials. Our Sydney facility is supported by a second manual manufacturing facility in Perth, Western Australia.

The Company continues to work closely with its contract research organisations in the US to deliver an expanded analysis and documentation in line with the guidance provided to the Company by the US FDA at our invitation meeting in May 2018. The Company has successfully met their in-house R&D activities to achieve manufacturing milestones as it progress through to first-in-human clinical trials.

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Recce has achieved:

  • Scale-up quantities of patented synthesis of RECCE® 327
  • Reproducibility of RECCE® 327 across multiple batches
  • Consistency in meeting high standards of internal and external Quality Assurance
  • Packaging and labelling for intravenous use meeting international standards and non-tampering protocols.
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