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