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