In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 0431, MK Drug Master File in Korea (0431, MK KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 0431, MK. The MFDS reviews the 0431, MK KDMF as part of the drug registration process and uses the information provided in the 0431, MK KDMF to evaluate the safety and efficacy of the drug.
After submitting a 0431, MK 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 0431, MK API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 0431, MK suppliers with KDMF on PharmaCompass.