In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a fluoromethyl hexafluoroisopropyl ether Drug Master File in Korea (fluoromethyl hexafluoroisopropyl ether KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of fluoromethyl hexafluoroisopropyl ether. The MFDS reviews the fluoromethyl hexafluoroisopropyl ether KDMF as part of the drug registration process and uses the information provided in the fluoromethyl hexafluoroisopropyl ether KDMF to evaluate the safety and efficacy of the drug.
After submitting a fluoromethyl hexafluoroisopropyl ether KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their fluoromethyl hexafluoroisopropyl ether API can apply through the Korea Drug Master File (KDMF).
click here to find a list of fluoromethyl hexafluoroisopropyl ether suppliers with KDMF on PharmaCompass.