In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a C3F8-gas Drug Master File in Korea (C3F8-gas KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of C3F8-gas. The MFDS reviews the C3F8-gas KDMF as part of the drug registration process and uses the information provided in the C3F8-gas KDMF to evaluate the safety and efficacy of the drug.
After submitting a C3F8-gas 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 C3F8-gas API can apply through the Korea Drug Master File (KDMF).
click here to find a list of C3F8-gas suppliers with KDMF on PharmaCompass.