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