Apimeds Pharmaceuticals Us's Comment on Supply Chain
The company purchases venom from its U.S. supplier, Apico, Inc., under a letter agreement granting exclusivity for pharmaceutical use in the United States until November 3, 2031, with exceptions for Apimeds Korea's use outside the U.S. Apico employs a proprietary venom harvesting method, complies with FDA current good manufacturing practice regulations, and maintains an active Drug Master File with the FDA. Apimeds Korea holds proprietary analytical and manufacturing methods for Apitoxin, a therapeutic bee venom product registered as an active pharmaceutical ingredient in South Korea. The company intends to file a Biologics License Application with the FDA for Apitox following Phase III clinical trials, seeking 12 years of market exclusivity. Regulatory compliance includes adherence to the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and other U.S. regulations governing biological products.
Apimeds Pharmaceuticals Us's Comment on Supply Chain
The company purchases venom from its U.S. supplier, Apico, Inc., under a letter agreement granting exclusivity for pharmaceutical use in the United States until November 3, 2031, with exceptions for Apimeds Korea's use outside the U.S. Apico employs a proprietary venom harvesting method, complies with FDA current good manufacturing practice regulations, and maintains an active Drug Master File with the FDA. Apimeds Korea holds proprietary analytical and manufacturing methods for Apitoxin, a therapeutic bee venom product registered as an active pharmaceutical ingredient in South Korea. The company intends to file a Biologics License Application with the FDA for Apitox following Phase III clinical trials, seeking 12 years of market exclusivity. Regulatory compliance includes adherence to the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and other U.S. regulations governing biological products.
Sources:
Apimeds Pharmaceuticals US, 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.
Updated on:
For your research, we’ve provided nine additional tables on Apimeds Pharmaceuticals US, Inc.’s suppliers.
You can find them in the navigation menu under Suppliers.
To download the tables, please subscribe.
Intraday data delayed per exchange requirements. All quotes are in local exchange time. Intraday data delayed 15 minutes for Nasdaq, and other exchanges. Fundamental and financial data for Stocks, Sector, Industry, and Economic Indicators provided by CSIMarket.com
Disclaimer: Information provided by CSIMarket.com is for informational purposes only and does not constitute investment advice, recommendation, or solicitation to buy or sell any security.
