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