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