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