Manufacturing

Regenicin’s cultured skin substitute and related product candidates will be manufactured either in-house or through contract manufacturers. All production will take place in FDA-compliant, cGMP-certified facilities initially within the United States.

The proprietary collagen scaffolds are produced domestically using purified closed herd collagen in an FDA cGMP-compliant facility. These materials are sourced exclusively from U.S.-grown bovine, harvested in specialized FDA-compliant closed herd facilities. They adhere to ISO 20224:42 standards, Code of Federal Regulations Title 61.49919 for xenotransplantation, and meet all U.S. Department of Agriculture requirements for being “Fit for Human Consumption.”