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Manufacturing

Situated in Sydney’s Macquarie Park and built to pharmaceutical specifications, Recce and its experimental 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 demonstrated manufacturing quality and volume capabilities for RECCE® 327’s indicated first in-human clinical trials.

The U.S. Food and Drug Administration (FDA) awarded RECCE® 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling it for Fast Track Designation, plus 10 years of market exclusivity post approval.

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We have established 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.

Recce Pharmaceutical’s synthetic process is efficient giving rise to a 99.9% product yield in several hours. It requires no specialised and expensive waste removal or risk of environmental contamination

product overview

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