In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 1,1,1,2,2,3,3,3-Octafluoropropane Drug Master File in Korea (1,1,1,2,2,3,3,3-Octafluoropropane KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 1,1,1,2,2,3,3,3-Octafluoropropane. The MFDS reviews the 1,1,1,2,2,3,3,3-Octafluoropropane KDMF as part of the drug registration process and uses the information provided in the 1,1,1,2,2,3,3,3-Octafluoropropane KDMF to evaluate the safety and efficacy of the drug.
After submitting a 1,1,1,2,2,3,3,3-Octafluoropropane 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 1,1,1,2,2,3,3,3-Octafluoropropane API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 1,1,1,2,2,3,3,3-Octafluoropropane suppliers with KDMF on PharmaCompass.