In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Basudin 10G Drug Master File in Korea (Basudin 10G KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Basudin 10G. The MFDS reviews the Basudin 10G KDMF as part of the drug registration process and uses the information provided in the Basudin 10G KDMF to evaluate the safety and efficacy of the drug.
After submitting a Basudin 10G 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 Basudin 10G API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Basudin 10G suppliers with KDMF on PharmaCompass.