Daewoong is the supplier and manufacturer of ABP-450, operating a purpose-built facility in South Korea that complies with FDA and EMA regulations. The company produces both the ABP-450 drug product and drug substance, with the latter manufactured through fermentation of Daewoong's Clostridium botulinum cell line. Daewoong's facility has undergone inspections by the FDA and the UK Medicines and Healthcare Products Regulatory Agency. Oversight responsibilities for products manufactured at the facility are maintained separately by Daewoong and Evolus. Daewoong was involved in lawsuits with Medytox concerning alleged misappropriation of trade secrets, which were settled in June 2021, resulting in a license to commercialize and manufacture ABP-450. Under a December 2019 agreement, Daewoong agreed to manufacture and supply ABP-450 exclusively to the reporting company for multiple territories, assuming all manufacturing costs, while the reporting company is responsible for other expenses. Other suppliers named in filings include AEON, Daewoong, Evolus, and Medytox.
Aeon Biopharma Inc's Comment on Supply Chain
Daewoong is the supplier and manufacturer of ABP-450, operating a purpose-built facility in South Korea that complies with FDA and EMA regulations. The company produces both the ABP-450 drug product and drug substance, with the latter manufactured through fermentation of Daewoong's Clostridium botulinum cell line. Daewoong's facility has undergone inspections by the FDA and the UK Medicines and Healthcare Products Regulatory Agency. Oversight responsibilities for products manufactured at the facility are maintained separately by Daewoong and Evolus. Daewoong was involved in lawsuits with Medytox concerning alleged misappropriation of trade secrets, which were settled in June 2021, resulting in a license to commercialize and manufacture ABP-450. Under a December 2019 agreement, Daewoong agreed to manufacture and supply ABP-450 exclusively to the reporting company for multiple territories, assuming all manufacturing costs, while the reporting company is responsible for other expenses. Other suppliers named in filings include AEON, Daewoong, Evolus, and Medytox.
Sources:
Aeon Biopharma inc 's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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