Situated in Sydney’s Macquarie Park and built to pharmaceutical specifications, Recce and its anti-infective formulations are produced in its wholly owned, automated manufacturing facility with existing output of 500 doses per hour at a 99.9% product yield.
Recce has a patented, automated, economical manufacturing process for our synthetic compounds. We have invested in a purpose built, wholly owned manufacturing facility, produced to the highest pharmaceutical standards. Furthermore, the manufacturing process is reproducible and has a CMC (Chemistry, Manufacturing, and Controls) data package, essential for clinical study materials.
We are proud to report the successful production of 5,000 doses of RECCE® 327 (R327) per week under Good Manufacturing Practices (GMP). This robust production complies with stringent regulatory guidelines, including those set by the U.S. Food and Drug Administration (FDA).
Due to the increased demand for R327 required for clinical studies, producing 5,000 doses of R327 per week is a significant achievement that provides surplus sample material for the Therapeutic Goods Administration (TGA) Special Access Scheme, Phase I, Phase II, and anticipated registrational Phase III opportunities ahead.
